A Study of Counseling Support for Cancer Survivors Age 65+
ConditionCancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to find out if a psychotherapy method called brief behavioral activation (BBA) can improve depression, anxiety, and overall well-being and encourage healthy lifestyle behaviors in English- and Spanish-speaking Older Adult Cancer Survivors (OACS). BBA is a therapeutic technique that guides people to set goals and engage in enjoyable or rewarding activities as a way of changing behavior and reducing symptoms of depression. In this study, BBA will be given by telephone or videoconference (remotely).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
As per self-report or medical record, ≥65 years old
As per self-report or medical record, has a history of cancer
currently with no evidence of disease (NED) AND/OR
6 months or more post-treatment
Disqualifiers
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 using the Columbia-Suicide Severity Rating Scale (CSSR) (MSK Standard) to determine level of risk;. Only those with active suicidal ideation will be excluded and referred to a higher level of care.
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 self-report, engagement in regular individual psychotherapeutic support that the participant is unable or unwilling to put on hold for the course of the study
Trial design
Design model
Sequential
Treatments tested in this trial
assessments (questionnaires)
Other interventionComplete assessments (questionnaires) before the intervention begins (at baseline), after the last session (around Week 10) and a follow-up assessment at Week 18 (or approximately 2 months after the sessions end.
Treatment groups
454 Participants
are divided into 2 treatment groupsGroup A: Behavioral Activation for Older Adult Cancer Survivor ( BBA-OAC)Experimental treatment 1 intervention
Group B: Supportive Psychotherapy (SP)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
change in Patient Health Questionnaire 9 (PHQ-9 at T2)
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). 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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov