Using behavioral activation to treat depression in older cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a psychotherapy method called behavioral activation (BA) delivered remotely via telephone or videoconference for treating depression in older adult cancer survivors. Participants will be individuals aged 65 and older with a history of cancer who are currently in survivorship clinics or have been disease-free for at least six months. The study aims to assess whether this approach can improve mental health outcomes in this vulnerable population. The intervention includes behavioral activation and supportive psychotherapy tailored to the needs of older adults.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Phase I:

* 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:

  * a patient in MSK Survivorship Clinics AND/OR
  * no evidence of disease (NED) AND/OR
  * 6 months or more post-treatment (patients on maintenance hormonal therapies are eligible)
* 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)

Phase II:

* As per self-report or medical record, ≥18 years old
* Fluent in English, as per self-reported fluency of "well" or "very well"\*
* As per self-report or medical record, has a history of cancer
* Elevated score on the PHQ-9: ≥5
* Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for Training Case participants)

Note. The eligibility criteria for Phase II allows inclusion of younger participants and those receiving active treatment due to the theoretical rationale that a single-session intervention will remove certain barriers that are believed to exist for these groups in receiving the longer, 10-session intervention.

Exclusion Criteria:

Phase I:

* As per PI determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. If a participant receives a score of \> 0 on item 9 of the PHQ-9, they will be referred to study PI for further evaluation. They will be excluded from participation in this study if the PI determines they would be appropriate for a higher level of care than BA may be able to provide.
* As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
* As per self-report or medical record, currently taking antidepressant medication for \< 3 month
* As per medical record, patient has impaired decision-making capacity

Phase II:

* As per PI determination, requires a higher level of care for current active suicidal ideation than current protocol is able to provide. If a participant receives a score of \> 0 on item 9 of the PHQ-9, they will be referred to study PI for further evaluation. They will be excluded from participation in this study if the PI determines they would be appropriate for a higher level of care than BA may be able to provide.
* As per medical record, patient has impaired decision-making capacity

  * Language verification: Prior to enrollment, patients will be asked the following two questions by research staff to verify English fluency necessary for participation in the study:

    1. How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
    2. What is your preferred language for healthcare? (must respond English)

Where it's running

• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Rebecca Saracino, PhD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Rebecca Saracino, PhD
• Email: jamesr@mskcc.org
• Phone: 646-888-0263

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.