Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT05087251
Status:
UNKNOWN
Last Update Posted:
2022-11-14
First Post:
2021-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Transitions Project: Efficacy Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differences in quality of life between study groups (Functional Assessment of Cancer Therapy-Lung Cancer score range 0-144, with higher scores indicating better quality of life)'}], 'secondaryOutcomes': [{'measure': 'Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differences in fear of cancer recurrence between study groups (Fear of Cancer Recurrence Scale 7, score range 7-35, with higher scores indicating more fear of cancer recurrence)'}, {'measure': 'Symptom burden: Edmonton Symptom Assessment Scale', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differences in symptom burden (Edmonton Symptom Assessment Scale score range 0-90, with higher scores indicating more symptom burden)'}, {'measure': 'Psychological symptom burden: Hospital Anxiety and Depression Scale', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differences in psychological symptom burden (Hospital Anxiety and Depression Scale score range 0-42 with higher scores indicating more psychological symptom burden)'}, {'measure': 'Social support: Multidimensional Scale of Perceived Social Support', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differencs in social support (Multidimensional Scale of Perceived Social Support score range 12-84, with higher scores indicating more social support)'}, {'measure': 'Social isolaton: Campaign to End Loneliness Measurement Tool', 'timeFrame': 'Up to 12 weeks', 'description': 'We will investigate longitudinal differences in social isolation (Campaign to End Loneliness measurement tool score range 0-12 with higher scores indicating more social isolation)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Cancer', 'Supportive Care'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve quality of life in patients with lung cancer who are transitioning from active treatment to surveillance.', 'detailedDescription': 'This is a randomized controlled trial to test the efficacy of a brief psychoeducational intervention relative to a control condition for improving quality of life in patients with lung cancer who are transitioning from treatment to surveillance.\n\nIn this study, participants will complete survey questions and will be randomly assigned to receive a 5-session program or a 1-session program.\n\nIt is expected that about 100 people will take part in this research study.\n\nThe American Lung Association is supporting this research by providing funding for the research study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 or older\n* Able to read and respond in English\n* Diagnosis of non-small cell lung cancer or small cell lung cancer\n* Documented curative treatment plan including systemic therapy +/- radiation and +/- surgery\n* Completed cancer treatment within past 3 weeks\n\n * If final treatment is systemic therapy +/- radiation: within 3 weeks after cancer care team determination that treatment is complete\n * If final treatment is surgery: within 3 weeks after hospital discharge following surgery\n\nExclusion Criteria:\n\n* Comorbid health condition that would interfere with study participation\n* Current participation in cognitive behavioral therapy treatment'}, 'identificationModule': {'nctId': 'NCT05087251', 'briefTitle': 'The Transitions Project: Efficacy Trial', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent', 'orgStudyIdInfo': {'id': '21-426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention: Five Psycho-educational Sessions', 'description': "Approximately 6 weeks after the patient's cancer treatment is complete, participants in the intervention arm will proceed to receive up to 5 study sessions (approximately weekly, \\~50 minutes each) with a trained interventionist focused on psychoeducational topics. This arm was designed to enhance patient skills to address key concerns during the transition from treatment to surveillance, using a cognitive-behavioral approach. Sessions will be based on an intervention manual.", 'interventionNames': ['Behavioral: Five Psycho-educational Session(s)']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Usual Care: One Psycho-educational Session', 'description': 'At approximately 6 weeks after treatment completion (as defined by our eligibility criteria), control patients will attend one study session (\\~50 minutes) with a study clinician. This session is designed to control for patient access and connection to psychosocial resources as recommended in recent work.', 'interventionNames': ['Behavioral: One Psycho-educational Session(s)']}], 'interventions': [{'name': 'Five Psycho-educational Session(s)', 'type': 'BEHAVIORAL', 'description': '5 psychoeducational sessions focused on skills for enhancing wellbeing, relationships, social support, and ability to cope with uncertainty', 'armGroupLabels': ['Intervention: Five Psycho-educational Sessions']}, {'name': 'One Psycho-educational Session(s)', 'type': 'BEHAVIORAL', 'description': '1 session focused on exploring goals and expectations for post-treatment quality of life, including supportive listening; assessment of unmet needs; preferences for support, and tailored referral recommendations', 'armGroupLabels': ['Enhanced Usual Care: One Psycho-educational Session']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lara Traeger, PhD', 'role': 'CONTACT', 'email': 'LTRAEGER@mgh.harvard.edu', 'phone': '617-643-4314'}, {'name': 'Lara Traeger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital Cancer Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sharon Bober, PhD', 'role': 'CONTACT', 'email': 'Sharon_Bober@DFCI.HARVARD.EDU', 'phone': '617-632-6547'}, {'name': 'Timothy Sannes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Lara Traeger, PhD', 'role': 'CONTACT', 'email': 'LTRAEGER@mgh.harvard.edu', 'phone': '(617) 643-4314'}], 'overallOfficials': [{'name': 'Lara Traeger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \\[contact information for Sponsor Investigator or designee\\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Partners Innovations team at http://www.partners.org/innovation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Lung Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lara Traeger', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}