Clinical trial NCT03528863: Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers
Official title: Being Present 2.0: Web-Based Mindfulness Meditation for Gastrointestinal Cancer Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Metastatic Gastrointestinal Carcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2018-05-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as assessed by evaluating recruitment rate
timeFrame: At end of enrollment (Up to 1 year)
measure: Feasibility as assessed by evaluating rate of refusal to participate
timeFrame: At end of enrollment (Up to 1 year)
measure: Feasibility as assessed by rate of attrition
timeFrame: At 8 weeks post end of enrollment (Up to 1 year)
measure: Acceptability as assessed by adherence to practice instructions
timeFrame: At 8 weeks after study start (Up to 1 year)
measure: Acceptability as assessed by adherence to practice instructions
timeFrame: At 8 weeks after study start (Up to 1 year)
measure: Acceptability as assessed by adherence to practice instructions
timeFrame: At 8 weeks after study start (Up to 1 year)
measure: Acceptability as assessed by adherence to practice instructions
timeFrame: At 8 weeks after study start (Up to 1 year)
Secondary outcomes:
measure: Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
timeFrame: At baseline, week 4 and week 8 after study start (Up to 1 year)
measure: Efficacy as assessed by National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS)
timeFrame: At baseline, week 4 and week 8 after study start (Up to 1 year)
measure: Efficacy as assessed by a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)
timeFrame: At baseline, week 4 and week 8 after study start (Up to 1 year)
measure: Efficacy as assessed by a "Are You at Peace?" one-item spiritual probe
timeFrame: At baseline, week 4 and week 8 after study start (Up to 1 year)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Chloe Atreya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dragomanovich HM, Dhruva A, Ekman E, Schoenbeck KL, Kubo A, Van Blarigan EL, Borno HT, Esquivel M, Chee B, Campanella M, Philip EJ, Rettger JP, Rosenthal B, Van Loon K, Venook AP, Boscardin C, Moran P, Hecht FM, Atreya CE. Being Present 2.0: Online Mindfulness-Based Program for Metastatic Gastrointestinal Cancer Patients and Caregivers. Glob Adv Health Med. 2021 Nov 3;10:21649561211044693. doi: 10.1177/21649561211044693. eCollection 2021.