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

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.

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