Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-04 @ 5:53 PM
Study NCT ID:
NCT03654404
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2018-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Hermioni_Amonoo@dfci.harvard.edu', 'phone': '617-525-7472', 'title': 'Hermioni L. Amonoo, Director of Well-Being and Cancer Research Program', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Death due to complications related to hematopoietic stem cell transplantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Positive Psychology (PP) Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - week 8 of intervention', 'description': 'Feasibility will be measured by examining the number of completed exercises.', 'unitOfMeasure': 'sessions completed out of 8 sessions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Acceptability of Exercises: Ease Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - week 8 of intervention', 'description': 'Participants will provide ratings of ease of completion after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = very difficult and 10 = very easy). Ratings from all 8 weeks were averaged.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Acceptability of Exercises: Utility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '1.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - week 8 of intervention', 'description': 'Participants will provide ratings of utility of completion after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not helpful and 10 = very helpful). Ratings from all 8 weeks were averaged.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in PANAS Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '35.17', 'spread': '5.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '37.08', 'spread': '4.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in score from baseline to 8 weeks', 'description': 'The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illness, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in LOT-R Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '18.75', 'spread': '3.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '19.50', 'spread': '3.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in score from baseline to 8 weeks', 'description': 'Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of dispositional optimism.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in HADS Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'classes': [{'title': 'HADS-D Baseline', 'categories': [{'measurements': [{'value': '6.58', 'spread': '2.15', 'groupId': 'OG000'}]}]}, {'title': 'HADS-D Week 8', 'categories': [{'measurements': [{'value': '6.00', 'spread': '2.00', 'groupId': 'OG000'}]}]}, {'title': 'HADS-A Baseline', 'categories': [{'measurements': [{'value': '5.75', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'HADS-A Week 8', 'categories': [{'measurements': [{'value': '5.08', 'spread': '3.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in score from baseline to 8 weeks', 'description': 'The Hospital Anxiety and Depression Scale (HADS), which consists of the HADS-depression subscale and HADS-anxiety subscale, is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically ill patients before and after the PP intervention. Both subscales consist of 7 items, and each item is scored on a 0-3 scale, 0 indicating no clinical severity or a lack of symptoms, and 3 indicating significant clinical severity or increased symptom frequency; the maximum score is for each scale 21 and the minimum score is a 0. Higher scores indicate higher levels of depression or anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in FACT-BMT Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '107.91', 'spread': '15.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '110', 'spread': '18.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in score from baseline to 8 weeks', 'description': 'The Functional Assessment of Cancer Therapy - Bone Marrow Transplant is a 47-item measure of the quality of life in patients undergoing bone marrow transplants before and after the PP intervention. There are five subscales, each including 7 items and various score ranges: Physical Well-Being (0-28), Social/Family Well-Being (0-28), Emotional Well-Being (0-24), Functional Well-Being (0-28), and Transplant (0-40). Each item is scored on a 5-point Likert scale based on patient agreement with each statement: 0 for "not at all," 1 for "a little bit," 2 for "somewhat," 3 for "quite a bit," and 4 for "very much." In each subscale, add items together to get the sum, then the sum is multiplied by 7, and finally, the sum is divided by the number of items answered to obtain the subscale score. The Physical and Emotional subscales are reverse scored. The total score is the sum of the subscale total added together and ranges from 0-148. The higher the score, the better the quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in PROMIS-PF-20 Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '85.67', 'spread': '8.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '86.33', 'spread': '10.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in score from baseline to 8 weeks', 'description': 'The Patient-Reported Outcomes Measurement Information System - Physical Function is a well-validated scale used to measure overall function before and after the PP intervention. The PROMIS-Fatigue is scored on a 5-point Likert scale based on how much the person filling out the questionnaire agrees with the statement or question. The minimum value is 1 indicating "not at all" and the maximum value is 5 indicating "very much". Higher scores indicate higher levels of fatigue. The PROMIS-PF scores range from 20-100, with 20 indicating lower or limited levels of physical functioning and 100 indicating no difficulty or higher levels of physical functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immediate Impact of Exercises: Optimism Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'classes': [{'title': 'pre-exercise', 'categories': [{'measurements': [{'value': '8.0', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'post-exercise', 'categories': [{'measurements': [{'value': '8.6', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 of intervention - Week 8 of intervention', 'description': 'Participants will provide ratings of their present level of optimism after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not optimistic and 10 = very optimistic). Ratings from all 8 weeks were averaged.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immediate Impact of Exercises: Positive Affect Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'classes': [{'title': 'pre-exercise', 'categories': [{'measurements': [{'value': '7.9', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'post-exercise', 'categories': [{'measurements': [{'value': '8.5', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 of intervention - Week 8 of intervention', 'description': 'Participants will provide ratings of their present level of positive affect after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not happy and 10 = very happy). Ratings from all 8 weeks were averaged.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.\n\nPositive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '12.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Optimism', 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'spread': '5.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Optimism was measured using the Life Orientation Test-Revised (LOT-R), a 10-item measure of dispositional (trait) optimism (range 0-24); higher scores indicate greater optimism', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-09', 'size': 378295, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-24T07:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2018-08-29', 'resultsFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2018-08-29', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-20', 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Positive Psychology (PP) Intervention', 'timeFrame': 'Baseline - week 8 of intervention', 'description': 'Feasibility will be measured by examining the number of completed exercises.'}, {'measure': 'Acceptability of Exercises: Ease Score', 'timeFrame': 'Baseline - week 8 of intervention', 'description': 'Participants will provide ratings of ease of completion after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = very difficult and 10 = very easy). Ratings from all 8 weeks were averaged.'}, {'measure': 'Acceptability of Exercises: Utility Score', 'timeFrame': 'Baseline - week 8 of intervention', 'description': 'Participants will provide ratings of utility of completion after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not helpful and 10 = very helpful). Ratings from all 8 weeks were averaged.'}], 'secondaryOutcomes': [{'measure': 'Changes in PANAS Scores', 'timeFrame': 'Change in score from baseline to 8 weeks', 'description': 'The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illness, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.'}, {'measure': 'Changes in LOT-R Scores', 'timeFrame': 'Change in score from baseline to 8 weeks', 'description': 'Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of dispositional optimism.'}, {'measure': 'Changes in HADS Scores', 'timeFrame': 'Change in score from baseline to 8 weeks', 'description': 'The Hospital Anxiety and Depression Scale (HADS), which consists of the HADS-depression subscale and HADS-anxiety subscale, is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically ill patients before and after the PP intervention. Both subscales consist of 7 items, and each item is scored on a 0-3 scale, 0 indicating no clinical severity or a lack of symptoms, and 3 indicating significant clinical severity or increased symptom frequency; the maximum score is for each scale 21 and the minimum score is a 0. Higher scores indicate higher levels of depression or anxiety.'}, {'measure': 'Changes in FACT-BMT Scores', 'timeFrame': 'Change in score from baseline to 8 weeks', 'description': 'The Functional Assessment of Cancer Therapy - Bone Marrow Transplant is a 47-item measure of the quality of life in patients undergoing bone marrow transplants before and after the PP intervention. There are five subscales, each including 7 items and various score ranges: Physical Well-Being (0-28), Social/Family Well-Being (0-28), Emotional Well-Being (0-24), Functional Well-Being (0-28), and Transplant (0-40). Each item is scored on a 5-point Likert scale based on patient agreement with each statement: 0 for "not at all," 1 for "a little bit," 2 for "somewhat," 3 for "quite a bit," and 4 for "very much." In each subscale, add items together to get the sum, then the sum is multiplied by 7, and finally, the sum is divided by the number of items answered to obtain the subscale score. The Physical and Emotional subscales are reverse scored. The total score is the sum of the subscale total added together and ranges from 0-148. The higher the score, the better the quality of life.'}, {'measure': 'Changes in PROMIS-PF-20 Scores', 'timeFrame': 'Change in score from baseline to 8 weeks', 'description': 'The Patient-Reported Outcomes Measurement Information System - Physical Function is a well-validated scale used to measure overall function before and after the PP intervention. The PROMIS-Fatigue is scored on a 5-point Likert scale based on how much the person filling out the questionnaire agrees with the statement or question. The minimum value is 1 indicating "not at all" and the maximum value is 5 indicating "very much". Higher scores indicate higher levels of fatigue. The PROMIS-PF scores range from 20-100, with 20 indicating lower or limited levels of physical functioning and 100 indicating no difficulty or higher levels of physical functioning.'}, {'measure': 'Immediate Impact of Exercises: Optimism Score', 'timeFrame': 'Week 1 of intervention - Week 8 of intervention', 'description': 'Participants will provide ratings of their present level of optimism after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not optimistic and 10 = very optimistic). Ratings from all 8 weeks were averaged.'}, {'measure': 'Immediate Impact of Exercises: Positive Affect Score', 'timeFrame': 'Week 1 of intervention - Week 8 of intervention', 'description': 'Participants will provide ratings of their present level of positive affect after each PP exercise, measured on a 10-point Likert scale (score range: 0-10, 0 = not happy and 10 = very happy). Ratings from all 8 weeks were averaged.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hematopoietic Stem Cell Transplant', 'Positive Psychology', 'Hematologic malignancy', 'Positive Psychological Intervention'], 'conditions': ['Hematologic Malignancy', 'Hematopoietic/Lymphoid Cancer', 'Blood Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to find out if a novel phone-based positive psychology intervention that focuses on improving health behaviors and positive emotions can help improve mood, health related quality of life, and overall function in patients who have just undergone hematopoietic stem cell transplantation as part of blood cancer treatment.', 'detailedDescription': 'Hematopoietic stem cell transplantation (HSCT) is a rigorous treatment for blood cancer patients that can be life-saving, but often causes psychological distress. The investigators hope that this study will help the research team to develop and implement a positive psychological intervention designed to help HSCT patients increase positive emotions such as hope, gratitude, and fulfillment while recovering from a stem cell transplant. Participants will be selected after receiving an allogeneic hematopoietic stem cell transplant treatment in the past 30 days at the Dana-Farber Cancer Institute (DFCI).\n\nIn this project, the investigators hope to:\n\n1. Test the feasibility and acceptability of a novel, 8-week, phone-based positive psychology intervention in a small cohort of post-HSCT patients (N = 20).\n2. Explore potential benefits of completing the intervention on outcomes of interest, such as positive affect and overall function.\n\nBaseline information about enrolled participants will be obtained from patients from the electronic medical record as required for characterization of our population. This information will include data regarding medical history, current medical variables, medications, and sociodemographic data.\n\nParticipants will be approached upon nearing their discharge from the hospital, approximately 30 days after their transplant. Between the time of their discharge and their 100-day post-transplant visit, there will be three check-in/psychosocial support phone calls at weeks 4, 8, and 12 after discharge to build rapport and discuss their recovery. Then, at week 14, participants will meet with the principal investigator to complete self-assessment questionnaires. The participants will then complete an 8-week phone-based positive psychology intervention, at the end of which the self-assessment questionnaires will be repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients with hematologic malignancies hospitalized for allogeneic HSCT at the DFCI inpatient units who are medically stable and appropriate for study approach\n* Ability to speak, read and write English\n* Access to a telephone\n\nExclusion Criteria:\n\n* Current major depressive episode, bipolar disorder, psychosis or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI)\n* Cognitive deficits impeding a study participant's ability to provide informed consent or participate adequately in the study assessed via the Brief Interview for Mental Status (BIMS)\n* Medical conditions precluding interviews"}, 'identificationModule': {'nctId': 'NCT03654404', 'briefTitle': 'A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients', 'orgStudyIdInfo': {'id': '18-225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive Psychology', 'description': 'Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment.\n\nAt approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).\n\nParticipants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention.', 'interventionNames': ['Behavioral: Positive Psychology Intervention']}], 'interventions': [{'name': 'Positive Psychology Intervention', 'type': 'BEHAVIORAL', 'description': 'Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.', 'armGroupLabels': ['Positive Psychology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Hermioni Amonoo, MD, MPP, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Well-Being and Cancer Research Program', 'investigatorFullName': 'Hermioni L.Amonoo, MD, MPP, MPH', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}