This trial studies how well web-based mindfulness meditation works in reducing distress in both participants with gastrointestinal cancer that has spread to other parts of the body, and their caregivers. Web-based mindfulness meditation, which uses audio exercises and interactive webinars taught by trained meditation instructors, may help participants with GI cancer and their caregivers reduce distress and improve their quality of life.
PRIMARY OBJECTIVES: I. To determine the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic gastrointestinal (GI) cancer receiving chemotherapy and their caregivers. SECONDARY OBJECTIVES: I. Estimate the efficacy of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic GI cancer receiving chemotherapy and their caregivers. OUTLINE: Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks. Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks. After completion of study, participants are followed up at 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
68
Receive web-based mindfulness meditation
Ancillary studies
University of California, San Francisco
San Francisco, California, United States
Feasibility as assessed by evaluating recruitment rate
Number of participants approached who consent to participate
Time frame: At end of enrollment (Up to 1 year)
Feasibility as assessed by evaluating rate of refusal to participate
Number of participants refusing to consent.
Time frame: At end of enrollment (Up to 1 year)
Feasibility as assessed by rate of attrition
Number of participants dropping out after start of intervention for any reason.
Time frame: At 8 weeks post end of enrollment (Up to 1 year)
Acceptability as assessed by adherence to practice instructions
Number of times participant practices during study, documented via website data capture
Time frame: At 8 weeks after study start (Up to 1 year)
Acceptability as assessed by adherence to practice instructions
Number of times participant watches recorded webinars, documented via website data capture
Time frame: At 8 weeks after study start (Up to 1 year)
Acceptability as assessed by adherence to practice instructions
Number of times patient participates in live webinars, documented via roll-call.
Time frame: At 8 weeks after study start (Up to 1 year)
Acceptability as assessed by adherence to practice instructions
Average duration of meditation session (measured in minutes), documented via website data capture.
Time frame: At 8 weeks after study start (Up to 1 year)
Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
0 to 10, with 10 being the worst level of distress
Time frame: At baseline, week 4 and week 8 after study start (Up to 1 year)
Efficacy as assessed by National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS)
Time frame: At baseline, week 4 and week 8 after study start (Up to 1 year)
Efficacy as assessed by a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)
Time frame: At baseline, week 4 and week 8 after study start (Up to 1 year)
Efficacy as assessed by a "Are You at Peace?" one-item spiritual probe
Time frame: At baseline, week 4 and week 8 after study start (Up to 1 year)
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