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The purpose of this study is to find out if a psychotherapy method called behavioral activation (BA) can be successfully delivered by telephone or videoconference (remotely) and can effectively treat depression in Older Adult Cancer Survivors (OACS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA) | Experimental | Older adult cancer survivors (OACS) will receive a Behavioral Activation intervention |
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| Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP) | Experimental | Older adult cancer survivors (OACS) will receive a Supportive Psychotherapy intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation | Behavioral | Sessions for both arms (BP & SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline:
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| Measure | Description | Time Frame |
|---|---|---|
| Difference of Patient Health Questionnaire 9 (PHQ-9) scores between study groups | Patient Health Questionnaire 9 (PHQ-9): The PHQ-9 consists of nine items, each of which corresponds to one of the nine symptoms required for a diagnosis of a major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders. Respondents are asked to rate how often they have been bothered by each of the nine symptoms over the preceding two weeks. Respondents rate each item on a four-point scale (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day). Its reliability and validity have been established in diverse general and medical populations. Total scores range from 0-27; In outpatient cancer settings, psychometric research suggests that a score of ≥8 indicates clinically significant depressive symptoms and should be used as a clinical cut-off . | 2 months post intervention |
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Inclusion Criteria:
As per self-report or medical record, ≥65 years old
As per self-report or medical record, has a history of cancer
As per medical record and/or clinician confirmation:
Fluent in English, as per self-reported fluency of "well" or "very well"*
As per self-report, able to communicate over video-conference and/or phone for sessions
Elevated score on the PHQ-9: ≥5 (N/A for Training Case participants)
Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for Training Case participants)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Saracino, PhD | Contact | 646-888-0263 | jamesr@mskcc.org | |
| Christian Nelson, PhD | Contact | 646-888-0030 | nelsonc@MSKCC.ORG |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Saracino, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38342735 | Derived | Saracino RM, Park EY, Demirjian C, Jutagir DR, McConnell KM, Schofield E, Raue PJ, Lejuez CW, Nelson CJ. Protocol for a randomized controlled trial of brief behavioral activation among older adult cancer survivors. J Geriatr Oncol. 2024 Jun;15(5):101719. doi: 10.1016/j.jgo.2024.101719. Epub 2024 Feb 10. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2024 | Sep 30, 2025 | ICF_000.pdf |
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| Supportive Psychotherapy | Behavioral | Sessions for both arms (BP & SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline:
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