Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers

Not Applicable

Completed

Interventions: Behavioral: Online Mindfulness Meditation
Other: Questionnaire Administration

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

ELIGIBLE PATIENTS: Carry a diagnosis of a metastatic GI cancer
ELIGIBLE PATIENTS: Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
ELIGIBLE PATIENTS: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
ELIGIBLE PATIENTS: Have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
ELIGIBLE PATIENTS: Be able to speak and read English
ELIGIBLE PATIENTS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
ELIGIBLE PATIENTS: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
ELIGIBLE PATIENTS: Be able to provide informed consent
ELIGIBLE CAREGIVERS: Be a spouse/partner, other family member, or a close friend of a patient who consented to participate in the Being Present 2.0 study
ELIGIBLE CAREGIVERS: Be able to speak and read English
ELIGIBLE CAREGIVERS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
ELIGIBLE CAREGIVERS: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
ELIGIBLE CAREGIVERS: Be able to provide informed consent

Exclusion Criteria

Have a current meditation practice (> 2 episodes or > 1 hour total, weekly)
Be currently enrolled in a stress reduction program
Have extensive hearing loss such that ability to participate in the study would be impaired
Have participated in the original Being Present pilot study (BP1)
Be caregivers of patients who decline Being Present 2.0 (BP2) study participation

Arm && Interventions

Group	Intervention	Description
Supportive Care (web-based mindfulness meditation)	Online Mindfulness Meditation	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.
Supportive Care (web-based mindfulness meditation)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Feasibility as assessed by evaluating recruitment rate	At end of enrollment (Up to 1 year)	Number of participants approached who consent to participate
Feasibility as assessed by rate of attrition	At 8 weeks post end of enrollment (Up to 1 year)	Number of participants dropping out after start of intervention for any reason.
Feasibility as assessed by evaluating rate of refusal to participate	At end of enrollment (Up to 1 year)	Number of participants refusing to consent.
Acceptability as assessed by adherence to practice instructions	At 8 weeks after study start (Up to 1 year)	Average duration of meditation session (measured in minutes), documented via website data capture.

Secondary Outcome Measures

Name	Time	Method
Efficacy as assessed by a "Are You at Peace?" one-item spiritual probe	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)	At baseline, week 4 and week 8 after study start (Up to 1 year)
Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer	At baseline, week 4 and week 8 after study start (Up to 1 year)	0 to 10, with 10 being the worst level of distress
Efficacy as assessed by a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)	At baseline, week 4 and week 8 after study start (Up to 1 year)

Locations (1): University of California, San Francisco
🇺🇸
San Francisco, California, United States