About this trial
The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Self-reported mild to moderately-severe symptoms of depression (score 5-19 on PHQ-9).
A diagnosis of stage 0-III breast, prostate, or colorectal cancer.
Completion of primary cancer treatment within 2 years (excludes hormone therapy).
An ability to provide informed consent.
Disqualifiers
Self-reported minimal and severe depressive symptoms (<4 and > 20 on PHQ-9).
Self-reported suicidal ideation (>1 on item 9 PHQ-9).
Another psychological, medical, or other condition/issue determined that necessitates priority treatment and/or that would interfere with participation (e.g., schizophrenia, borderline personality disorder)
Current or recent substance abuse/dependence.
Trial design
Parallel
Treatments tested in this trial
MINDSET
BehavioralParticipants randomized to MINDSET will receive a text message at their preferred time each day for 8 weeks containing a link to the 15-minute audio content. At the end of each week (on day 7), participants will receive a second link to the weekly survey in the text. Participants will be able to play the audio content on their device by clicking the first link and access the weekly survey by clicking the second.
Enhanced Usual Care (EUC)
BehavioralParticipants will receive a 1-page brochure summarizing publicly available information on depression self-care strategies via text each week for 8 weeks on the same day they receive the text message containing a link to the weekly survey (day 7). This information will come from the Facing Forward: Life After Cancer Treatment booklet from the National Cancer Institute.38 Weekly topics will include: 1) Reducing stress; 2) Coping with stress; 3) Coping with depression; 4) Feeling angry; 5) Feeling alone; 6) Finding meaning after treatment; 7) Social relationships; and 8) Seeking support. These materials do not include any content on mindfulness or cognitive therapy.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility as assessed by listening rate
80% listening rate of daily audio content
Feasibility as assessed by sample retention rate
80% sample retention
Acceptability rate as assessed by satisfaction rating of daily audio content
(\>8 median satisfaction rating of daily audio content is measured as accepatble
Acceptability rate as assessed by Client Satisfaction Questionnaire (CSQ-8) post-MINDSET
\>24 on the Client Satisfaction Questionnaire (CSQ-8) post-MINDSET will be considered as acceptable. CSQ-8 is a list of questions rating the satisfaction ranging from quite dissatisfied to very satisfied
Secondary outcomes
Symptoms of depression as measured by PROMIS-D-SF
The PROMIS-D-SF is an 8-question survey that measures depression on a scale from 1 (never) to 5 (always).
Symptoms of anxiety as measured by PROMIS-A-SF
The PROMIS-A-SF is an 8-question survey that measures anxiety on a scale from 1 (never) to 5 (always).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: