Depression, Cancer, Stage III Breast Cancer, Stage II Breast Cancer, Stage I Breast Cancer, Stage III Prostate Cancer, Stage II Prostate Cancer, Stage I Prostate Cancer, Stage III Colorectal Cancer, Stage II Colorectal Cancer, Stage I Colorectal Cancer
Conditions
Keywords
Post treatment Depression
Brief summary
The purpose of this study is to develop and test a new intervention to reduce depressive symptoms in post-treatment cancer participants.
Detailed description
Mindfulness-based interventions (MBIs), including Mindfulness-based Cognitive Therapy (MBCT), reduce depressive symptoms in medically ill populations, including cancer survivors. However, MBIs have limitations, and if improved, could dramatically increase their clinical reach and impact. Most standardized MBIs are group-based, time intensive, difficult to scale, and can be costly. Thus, only a small portion of patients ever engage with MBIs. Digital approaches to delivering mindfulness content (apps and brief MBIs) have shown promise for addressing these barriers to accessibility and scalability. However, these digital approaches are not typically tailored for people with medical illness, like cancer, and/or have poor adherence. Mindfulness app user engagement decreases by 90% within 7 days of download, and the average total use of the app is only 16-21 minutes. Moreover, a recent review of MBIs that included standardized group-based MBIs (e.g., Mindfulness-Based Stress Reduction \[MBSR\]) and three mindfulness-based apps (e.g., Calm) estimated a 40-60% adherence rate of assigned at-home practice (30-45 minutes/day) in cancer survivors during the MBI, which further declines post-intervention. This suggests that the currently prescribed daily practice dosages are not feasible or accepted by this population. Thus, a brief MBI that optimizes the accessibility and scalability and other benefits of digital and asynchronous delivery, in a feasible and acceptable format, is critically needed for people with depressive symptoms and medical illness. MBCT, adapted into a brief, daily and digitally delivered format, could increase access, scalability, acceptability, and adherence. While consistent practice for longer sessions yields the most benefit,21 studies have shown improved mood following 5 and 13 minutes of daily meditation for 2 and 8 weeks, respectively. Further, because creating and sustaining a new behavior, like daily meditation, requires consistent repetition, it is plausible that delivering content in short, digestible segments each day, as opposed to longer, weekly sessions, could improve adherence and sustain engagement. The full-length, 8-week MBCT protocol delivered digitally reduces depressive symptoms in cancer survivors, and the standardized 8-week MBCT protocol has already been abbreviated from 2- to 1-hour weekly groups (MBCT-Brief). When tested via remote delivery (telephone), MBCT-Brief showed a decrease in depressive symptoms in participants with medical illness (i.e., hypertension). Because of its abbreviated format and evidence for reducing depressive symptoms in people with medical illness, MBCT-Brief is a logical and feasible intervention to adapt into a daily text-delivered format for depressive symptoms in post-treatment cancer survivors.
Interventions
BEHAVIORALMINDSET
Participants 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.
BEHAVIORALEnhanced Usual Care (EUC)
Participants 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.
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Self-reported mild to moderately-severe symptoms of depression (score 5-19 on PHQ-9). 2. A diagnosis of stage 0-III breast, prostate, or colorectal cancer. 3. Completion of primary cancer treatment within 2 years (excludes hormone therapy). 4. An ability to provide informed consent. 5. An ability to read and speak English. 6. Access to a web-enabled device (phone, tablet, computer).
Exclusion criteria
1. Self-reported minimal and severe depressive symptoms (\<4 and \> 20 on PHQ-9). 2. Self-reported suicidal ideation (\>1 on item 9 PHQ-9). 3. 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) 4. Current or recent substance abuse/dependence. 5. Stage IV cancer diagnosis. 6. A cancer recurrence actively requiring treatment. 7. Self-reported active mindfulness practice. 8. Prior participation in a formal mindfulness program (e.g., MBCT, Mindfulness-Based Stress Reduction Program, Mindfulness-Based Cancer Recovery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as assessed by listening rate | 12 weeks | 80% listening rate of daily audio content |
| Feasibility as assessed by sample retention rate | 12 weeks | 80% sample retention |
| Acceptability rate as assessed by satisfaction rating of daily audio content | 12 weeks | (\>8 median satisfaction rating of daily audio content is measured as accepatble |
| Acceptability rate as assessed by Client Satisfaction Questionnaire (CSQ-8) post-MINDSET | 12 weeks | \>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
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of depression as measured by PROMIS-D-SF | 12 weeks | 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 | 12 weeks | The PROMIS-A-SF is an 8-question survey that measures anxiety on a scale from 1 (never) to 5 (always). |
Countries
United States
Contacts
CONTACTNarissa McCarty, MS
PRINCIPAL_INVESTIGATORChelsea Siwik, PhD
Case Comprehensive Cancer Center, Cleveland Clinic
Outcome results
None listed