Survivorship
Conditions
Keywords
Older Adult Cancer Survivors, history of cancer, 22-248, Memorial Sloan Kettering Cancer Center
Brief summary
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)
Interventions
BEHAVIORALBehavioral Activation
Sessions for both arms (BP \& SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline: * Full participants (not training cases): Ten sessions (30-50 minutes each) will be delivered approximately weekly over a 10-week period (+10 weeks). * Training case participants: Ten sessions (30-50 minutes each) will be delivered over an approximately 5-week period (+10 weeks).
BEHAVIORALSupportive Psychotherapy
Sessions for both arms (BP \& SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline: * Full participants (not training cases): Ten sessions (30-50 minutes each) will be delivered approximately weekly over a 10-week period (+10 weeks). * Training case participants: Ten sessions (30-50 minutes each) will be delivered over an approximately 5-week period (+10 weeks).
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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 self-report or medical record, current weekly psychotherapy or currently taking an antidepressant for \<3 months. * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of Patient Health Questionnaire 9 (PHQ-9) scores between study groups | 2 months post intervention | 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 . |
Countries
United States
Contacts
CONTACTRebecca Saracino, PhD
CONTACTChristian Nelson, PhD
PRINCIPAL_INVESTIGATORRebecca Saracino, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed