Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT05358951
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2022-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2022-04-28', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Insomnia Severity at 16 weeks (optional)', 'timeFrame': '16 weeks post-intervention session', 'description': 'The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used.'}, {'measure': 'Initial Satisfaction with Intervention Session', 'timeFrame': 'Up to 4 weeks post-intervention', 'description': 'Study specific questionnaire assessing intervention acceptability, credibility and participant satisfaction'}, {'measure': 'Satisfaction with Coaching Sessions', 'timeFrame': 'Up to 4 weeks post-intervention', 'description': 'Study specific questionnaire describing satisfaction with coaching sessions'}, {'measure': 'Final satisfaction with the intervention', 'timeFrame': '8 Weeks post-intervention session', 'description': 'Study specific questionnaire asking about participant satisfaction with the intervention'}], 'primaryOutcomes': [{'measure': 'Insomnia Severity Change at 8 Weeks', 'timeFrame': 'Baseline to 8-weeks post-intervention session', 'description': 'The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used.'}], 'secondaryOutcomes': [{'measure': 'Profile of Mood States Change at 8 weeks', 'timeFrame': 'Baseline to 8-weeks post-intervention session', 'description': 'The Profile of Mood States - Short Form (POMS-SF), a 35-item measure of participant mood states that provides multiple scales including an overall Total Mood Disturbance (TMD) score will be used'}, {'measure': 'Profile of Mood States Change at 4 weeks', 'timeFrame': 'Baseline to 4-weeks post-intervention session', 'description': 'The Profile of Mood States - Short Form (POMS-SF), a 35-item measure of participant mood states that provides multiple scales including an overall Total Mood Disturbance (TMD) score will be used'}, {'measure': 'Insomnia Severity Change at 4 weeks', 'timeFrame': 'Baseline to 4-weeks post-intervention session', 'description': 'The Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms will be used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insomnia', 'Insomnia Due to Medical Condition', 'Cancer'], 'conditions': ['Insomnia', 'Insomnia Due to Medical Condition', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '38019571', 'type': 'DERIVED', 'citation': 'Michaud AL, Bice B, Miklos E, McCormick K, Medeiros-Nancarrow C, Zhou ES, Recklitis CJ. Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial. JMIR Res Protoc. 2023 Nov 29;12:e52315. doi: 10.2196/52315.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to learn if a single online education session, with or without individualized coaching sessions, can help improve young adult cancer survivors' (YACS) sleep.\n\nThe name of the study intervention is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).", 'detailedDescription': 'This study is a randomized controlled trial of young adult cancer survivors with clinically significant symptoms of insomnia to evaluate the cognitive-behavioral based Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).\n\nAll participants will take part in a single STEP-YA session, during which they will complete baseline measures prior to randomization and then receive the STEP-YA intervention. Participants will then be randomly assigned to receive the STEP-YA intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote coaching sessions (coaching condition). Participants will also complete follow-up measures 4 and 8 weeks post-baseline.\n\nIt expected that about 74 people will take part in this study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nTo be determined by patient self-report from eligibility screening with potential participants. (See Appendix A for eligibility screening materials). Participants must be screened for eligibility ≤2 weeks prior to study enrollment. Participants who are screened earlier must be rescreened within this period.\n\n* Age 20-39\n* History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior\n* No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned\n* Significant insomnia as evidenced by an Insomnia Severity Index score ≥12\n* Able to read and write in English\n\nExclusion Criteria:\n\n* Survivors who report ever being diagnosed with Bipolar Disorder.\n* Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months.\n* Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period.\n* Survivors who report being diagnosed with sleep apnea who are not receiving recommended medical treatment for their sleep apnea (as assessed by screening questions, see Appendix A).\n* Survivors who report suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).\n* Survivors who report their usual bedtime does not fall between 5:00 pm and 5:00 am.\n* Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery)\n* Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.\n* Prior participation in a research study which provided an educational or behavioral intervention for insomnia\n* Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital.\n* Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia."}, 'identificationModule': {'nctId': 'NCT05358951', 'briefTitle': 'Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA)', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): An Online Educational Intervention for Insomnia', 'orgStudyIdInfo': {'id': '21-613'}, 'secondaryIdInfos': [{'id': 'R21CA261863', 'link': 'https://reporter.nih.gov/quickSearch/R21CA261863', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NON-COACHING CONDITION STEP-YA', 'description': 'Participants will receive a single online education session and complete online questionnaires then be randomized to not receive additional coaching support sessions.\n\nParticipates will also complete follow up questionaires at 4 and 8 weeks post baseline.', 'interventionNames': ['Behavioral: STEP-YA without Coaching']}, {'type': 'EXPERIMENTAL', 'label': 'COACHING CONDITION STEP-YA', 'description': 'Participants will receive a single online education session and complete online questionnaire then be randomized to receive 2 individualized remote coaching sessions.\n\nParticipates will also complete follow up questionaires at 4 and 8 weeks post baseline.', 'interventionNames': ['Behavioral: STEP-YA with Coaching']}], 'interventions': [{'name': 'STEP-YA with Coaching', 'type': 'BEHAVIORAL', 'description': 'Online instruction on behavioral changes to improve sleep with 2 additional individually coached session', 'armGroupLabels': ['COACHING CONDITION STEP-YA']}, {'name': 'STEP-YA without Coaching', 'type': 'BEHAVIORAL', 'description': 'Online instruction on behavioral changes to improve sleep without additional individually coached session', 'armGroupLabels': ['NON-COACHING CONDITION STEP-YA']}]}, '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': 'Christopher J Recklitis, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, '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 Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christopher Recklitis, PhD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}