Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT03536702
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2018-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Group Led Creative Writing on Mood in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'muj14@psu.edu', 'phone': '717-531-8678', 'title': 'Monika Joshi, MD, MRCP', 'organization': 'MS Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Emotional Thermometer Subscale 1- Distress at Final', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Emotional Thermometer Subscale 2 - Anxiety at Final', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Emotional Thermometer Subscale 3 - Depression at Final', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.re.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Emotional Thermometer Subscale 4-anger at Final', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score..', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Emotional Thermometer Subscale 5-need Help at Final', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Emotional Thermometer Score (Total) at Final', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depression Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Severity of depression symptoms before and after intervention between two groups. The validated depression questionnaire, the Patient Health Questionnaire-9 (PHQ-9), will be used to predict changes. This questionnaire includes 9 questions, that describes individual symptoms of depression and asks individuals to asses how much each depression symptoms has bothered them in the last two weeks, from 0 (not at all) to 3 (nearly every day). The total score is compiled to represent a final depression severity score, with higher scores indicating worse severity, at a maximum value of 27 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anxiety Symptoms', 'timeFrame': '4 months', 'description': 'Severity of anxiety symptoms before and after intervention between two groups. The validated anxiety questionnaire, the Generalized Anxiety Disorder - 7 Scale, will be used to predict changes. This includes 7 questions describing symptoms of generalized anxiety, asking individual patients to rate how much those symptoms have bothered the individual in the past two weeks, from a score of 0 (not at all) to 3 (nearly every day). The total of the scores will be used to represent anxiety symptoms score, with a minimum score of 0 and a maximum score of 21, with higher score representing increasing severity of anxiety.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Self Reported Somatic Symptoms at Final', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '16'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Self-reported somatic symptoms pre and post intervention in two groups. We will use the Somatic Symptom Scale - 8 (SSS-8) to quantify somatic symptom burden. The scale is composed of 8 questions with options to choose a score of 0 (not at all) - 4 (very much) to describe degree of distress caused by individual somatic symptoms. A total of the 8 scores is used as a final value for the SSS-8, with higher scores indicating worse Somatic Symptom severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depression Symptoms at Final', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Severity of depression symptoms before and after intervention between two groups. The validated depression questionnaire, the Patient Health Questionnaire-9 (PHQ-9), will be used to predict changes. This questionnaire includes 9 questions, that describes individual symptoms of depression and asks individuals to asses how much each depression symptoms has bothered them in the last two weeks, from 0 (not at all) to 3 (nearly every day). The total score is compiled to represent a final depression severity score, with higher scores indicating worse severity, at a maximum value of 27 points', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Status of Cancer at Consent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'title': 'Cured', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'New', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Progression', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stable', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'consent', 'description': 'Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Difference in number of emergency room visits and hospitalizations during study period between control and intervention group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subject That Were Not Hospital or ER Admissions After Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Difference in number of emergency room visits and hospitalizations during study period between control and intervention group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Emergency Room Visits and Hospitalizations Per Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'Difference in number of emergency room visits and hospitalizations per subject during study period between control and intervention group', 'unitOfMeasure': 'ER visits and hospitalizations', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Status of Cancer at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'title': 'stable', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Progression', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'OG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Difference in number of emergency room visits and hospitalizations by subject during study period between control and intervention group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'FG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'comment': 'Competers are those who signed consent took baseline measures and at least one class', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': '60 subjects signed consent. Results reported are for completers only. Completers are participants who signed consent, were randomized, completed baseline measures and took at least one class after baseline.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.\n\nCreative Writing Workshop: This group will participate in a writing workshop in group sessions.'}, {'id': 'BG001', 'title': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.\n\nIndependent Writing - Control Group: This group will receive a book for a self writing session.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '61.9', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mood Score Baseline Emotional Thermometer Scale subscale 1-distress', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '6.5'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '6.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Emotional Thermometer subscale 2- anxiety baseline', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.5', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Emotional Thermometer subscale 3- depression baseline', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1.2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score..', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Emotional Thermometer subscale 4- anger baseline', 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '0.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Emotional Thermometer subscale 5- need help baseline', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1.5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Emotional Thermometer score (total) at baseline', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '9.5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '21'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '25'}]}]}], 'paramType': 'MEDIAN', 'description': 'A validated Emotional Thermometer Scales will be used to predict changes in parameters pre and post-intervention. The validated Emotional Thermometer Scale (ETS) has five dimensions (distress, anxiety, depression, anger and need help), which are all continuous variables and range from 0 (best) to 10 (worst). Both the individual scores will be analyzed for each dimension as well as a sum of the five scores will be collected to represent average mood score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Self Reported Somatic Symptoms baseline', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '16'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'description': 'Self-reported somatic symptoms pre and post intervention in two groups. We will use the Somatic Symptom Scale - 8 (SSS-8) to quantify somatic symptom burden. The scale is composed of 8 questions with options to choose a score of 0 (not at all) - 4 (very much) to describe degree of distress caused by individual somatic symptoms. A total of the 8 scores is used as a final value for the SSS-8, with higher scores indicating worse Somatic Symptom severity', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Depression Symptoms baseline', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'description': 'Severity of depression symptoms before and after intervention between two groups. The validated depression questionnaire, the Patient Health Questionnaire-9 (PHQ-9), will be used to predict changes. This questionnaire includes 9 questions, that describes individual symptoms of depression and asks individuals to asses how much each depression symptoms has bothered them in the last two weeks, from 0 (not at all) to 3 (nearly every day). The total score is compiled to represent a final depression severity score, with higher scores indicating worse severity, at a maximum value of 27 points', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Anxiety Symptoms baseline', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'description': 'The validated anxiety questionnaire, the Generalized Anxiety Disorder - 7 Scale, will be used to predict changes. This includes 7 questions describing symptoms of generalized anxiety, asking individual patients to rate how much those symptoms have bothered the individual in the past two weeks, from a score of 0 (not at all) to 3 (nearly every day). The total of the scores will be used to represent anxiety symptoms score, with a minimum score of 0 and a maximum score of 21, with higher score representing increasing severity of anxiety', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Following the Intention-to-treat (ITT) principle, we report the status of all the 60 consented participants, who have been randomized with 1:2 ratio to two groups (control and intervention). Of those 60, 34 completed the baseline measures and took one class.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-24', 'size': 1703191, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-26T11:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': "Participants will be randomized within strata formed by cancer type in order to assure that these potentially important confounding variables are balanced across groups. Patients will be enrolled on a rolling basis over a three-month period, allowing patients in intervention arm to participate in 3 months workshops (workshops would be held once every 2 weeks). Patients in control arm will be provided a book (Writing Down Bones by Natalie Goldberg) about creative writing and will be asked to do activities for 1.5 hours every 2 weeks. After three months, control group participants can join creative writing workshops at their discretion for the remaining period for writing workshops. Both group members will receive follow up surveys twice a month for two months at the completion of the participant's three-month study period."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2018-03-28', 'resultsFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-16', 'studyFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Status of Cancer at Consent', 'timeFrame': 'consent', 'description': 'Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.'}, {'measure': 'Number of Subjects Who Were Admitted to the Hospital and ER Admissions During Study Time', 'timeFrame': '4 months', 'description': 'Difference in number of emergency room visits and hospitalizations during study period between control and intervention group'}, {'measure': 'Number of Subject That Were Not Hospital or ER Admissions After Study', 'timeFrame': '4 months', 'description': 'Difference in number of emergency room visits and hospitalizations during study period between control and intervention group'}, {'measure': 'Number of Emergency Room Visits and Hospitalizations Per Subject', 'timeFrame': '4 months', 'description': 'Difference in number of emergency room visits and hospitalizations per subject during study period between control and intervention group'}, {'measure': 'Status of Cancer at End of Study', 'timeFrame': '4 months', 'description': 'Comparison of status of cancer (stable, progressing, in remission) between intervention and control group.'}, {'measure': 'Number of Subject That Were Not Hospitalized or in the Emergency Room During Study Time', 'timeFrame': '4 months', 'description': 'Difference in number of emergency room visits and hospitalizations by subject during study period between control and intervention group'}], 'primaryOutcomes': [{'measure': 'Emotional Thermometer Subscale 1- Distress at Final', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.'}, {'measure': 'Emotional Thermometer Subscale 2 - Anxiety at Final', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.'}, {'measure': 'Emotional Thermometer Subscale 3 - Depression at Final', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.re.'}, {'measure': 'Emotional Thermometer Subscale 4-anger at Final', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score..'}, {'measure': 'Emotional Thermometer Subscale 5-need Help at Final', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.'}, {'measure': 'Emotional Thermometer Score (Total) at Final', 'timeFrame': '4 months', 'description': 'Mood scores before and after intervention (after completion of entire session this may vary as some patients may not be able to complete six sessions). A validated Emotional Thermometer Scales (ETS) will be used to predict changes pre and post-intervention. The validated ETS has five dimensions (distress, anxiety, depression,anger, need help), which are all continuous variables and range from 0 to 10 with 0 being no emotional symptoms and 10 extremely emotional. Individual scores will be analyzed as well as a sum of the five scores will be collected to represent average mood score.score.'}], 'secondaryOutcomes': [{'measure': 'Depression Symptoms', 'timeFrame': '4 months', 'description': 'Severity of depression symptoms before and after intervention between two groups. The validated depression questionnaire, the Patient Health Questionnaire-9 (PHQ-9), will be used to predict changes. This questionnaire includes 9 questions, that describes individual symptoms of depression and asks individuals to asses how much each depression symptoms has bothered them in the last two weeks, from 0 (not at all) to 3 (nearly every day). The total score is compiled to represent a final depression severity score, with higher scores indicating worse severity, at a maximum value of 27 points.'}, {'measure': 'Anxiety Symptoms', 'timeFrame': '4 months', 'description': 'Severity of anxiety symptoms before and after intervention between two groups. The validated anxiety questionnaire, the Generalized Anxiety Disorder - 7 Scale, will be used to predict changes. This includes 7 questions describing symptoms of generalized anxiety, asking individual patients to rate how much those symptoms have bothered the individual in the past two weeks, from a score of 0 (not at all) to 3 (nearly every day). The total of the scores will be used to represent anxiety symptoms score, with a minimum score of 0 and a maximum score of 21, with higher score representing increasing severity of anxiety.'}, {'measure': 'Self Reported Somatic Symptoms at Final', 'timeFrame': '4 months', 'description': 'Self-reported somatic symptoms pre and post intervention in two groups. We will use the Somatic Symptom Scale - 8 (SSS-8) to quantify somatic symptom burden. The scale is composed of 8 questions with options to choose a score of 0 (not at all) - 4 (very much) to describe degree of distress caused by individual somatic symptoms. A total of the 8 scores is used as a final value for the SSS-8, with higher scores indicating worse Somatic Symptom severity.'}, {'measure': 'Depression Symptoms at Final', 'timeFrame': '4 months', 'description': 'Severity of depression symptoms before and after intervention between two groups. The validated depression questionnaire, the Patient Health Questionnaire-9 (PHQ-9), will be used to predict changes. This questionnaire includes 9 questions, that describes individual symptoms of depression and asks individuals to asses how much each depression symptoms has bothered them in the last two weeks, from 0 (not at all) to 3 (nearly every day). The total score is compiled to represent a final depression severity score, with higher scores indicating worse severity, at a maximum value of 27 points'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer Patients']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'DOI: 10.1200/JCO.2017.35.31_suppl.178 Journal of Clinical Oncology 35, no. 31_suppl (November 2017) 178-178.'}], 'seeAlsoLinks': [{'url': 'http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.31_suppl.178', 'label': 'Abstract presented at Palliative Care Symposium 11/2017'}]}, 'descriptionModule': {'briefSummary': "The primary purpose of this study is to determine whether creative writing in newly diagnosed cancer patients and those with recent progression in their disease will have a positive impact on their mental health. Using a randomized controlled trial approach, emotion thermometers will be employed to evaluate participants' responses on a number of domains, such as anxiety, depression, despair, and anger along with a series of survey questions to monitor changes in depressive and anxiety symptoms. Open-ended survey questions will be used to capture how a creative writing intervention impacts participants' experience of their illness. Melissa Greene's Write from the Heart program focuses more on creative writing rather than cancer focused topics. Patients in the intervention arm will complete -one and a half hour group sessions every two weeks over the span of 3 months. Participants in the active control arm will be provided a book (i.e., Writing Down Bones by Natalie Goldberg) about creative writing and will be asked to do activities for 1.5 hrs every 2 weeks for a period of 3 months.", 'detailedDescription': "Mental wellness before and after intervention in both arms. A validated Emotional Thermometer Scales will be used to predict changes in parameters reflecting participants' mental health pre- and post-intervention. Survey questions focused on symptoms of depression and anxiety will be used to monitor for changes in mental wellness pre- and post-intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNewly diagnosed with any stage or type of cancer within 3 months OR progression of disease within 3 months of enrollment. Recurrence of cancer within 3 months of enrollment would also be eligible as it will be considered as progression of cancer Ability to understand English language and ability to write without any functional difficulty ECOG performance status 0-3\n\nExclusion Criteria:\n\nInability to give informed consent Severe psychiatry illness (e.g., uncontrolled depression, schizophrenia or psychosis) Severe cognitive impairment Pregnant females Inability to write or understand English'}, 'identificationModule': {'nctId': 'NCT03536702', 'briefTitle': 'Effect of Group Led Creative Writing on Mood in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Effect of Group Led Creative Writing on Mood in Cancer Patients', 'orgStudyIdInfo': {'id': 'PSCI 18-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Creative Writing Workshop', 'description': 'The intervention arm will receive a dedicated workshop for one and a half hours every 2 weeks for 3 months.', 'interventionNames': ['Other: Creative Writing Workshop']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Independent Writing - Control Group', 'description': 'The control arm will receive a book (i.e., Writing Down Bones by Natalie Goldberg) on creative writing and asked to read and do writing activities for one and a half hours once every two weeks for 3 months.', 'interventionNames': ['Other: Independent Writing - Control Group']}], 'interventions': [{'name': 'Creative Writing Workshop', 'type': 'OTHER', 'description': 'This group will participate in a writing workshop in group sessions.', 'armGroupLabels': ['Creative Writing Workshop']}, {'name': 'Independent Writing - Control Group', 'type': 'OTHER', 'description': 'This group will receive a book for a self writing session.', 'armGroupLabels': ['Independent Writing - Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Cancer Institute', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Monika Joshi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State Hershey Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Medicine, Division of Hematology-Oncology', 'investigatorFullName': 'Monika Joshi', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}