Cancer Survivors
Conditions
Brief summary
This is a pilot feasibility study of a group-based, mind body intervention for managing stress and fear of recurrence and promoting resiliency among adult cancer survivors.
Interventions
BEHAVIORALMind-Body Program for Fear of Recurrence
An adapted protocol of the Relaxation Response Resiliency Program, a manualized, group-based, multimodal mind body program. Protocol adaptation includes refinement of content and study procedures to target fear of cancer recurrence (FCR) among adult cancer survivors.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must have a history of breast, lung, colorectal, hematologic, prostate, melanoma, or gynecological cancer (by medical record and/or self-report) 2. Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy) between 3 to 30 months ago 3. Ages 18 and older (by medical record and/or self-report)
Exclusion criteria
1. Self-reported inability to speak and write in English 2. Concurrent participation in weekly, group-based psychosocial or mind-body programs 3. Serious mental illness (by medical record and/or self-report) as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year. 4. Inability to travel to necessary study visits 5. No e-mail address to access online assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (i.e., retention at initial follow-up assessment) | Through study completion (approximately 5 months) | The primary metric for assessing Feasibility will be retention at the initial follow-up assessment. Reasons for ineligibility, refusal, or dropping out will be measured. |
| Acceptability | During intervention group sessions (approximately 2 months) | The primary metric for assessing Acceptability will be a five-item, investigator developed self-report questionnaire. Following each study session, participants will be asked to rate (1=not at all to 5=very much) the enjoyableness, convenience, helpfulness, relevancy, odds of future use, and overall satisfaction of the session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear of Cancer Recurrence | Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up | Fear of Cancer Recurrence Inventory. Validated self-report measure of fear of cancer recurrence. 42 items across 7 subscales (triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance). Higher scores indicate more fear of recurrence. Severity subscale score ≥16 indicates elevated FCR. |
Countries
United States
Outcome results
None listed