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

Being Present 2.0: Web-Based Mindfulness Meditation for Gastrointestinal Cancer Patients and Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Caregiver; Metastatic Gastrointestinal Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Online Mindfulness Meditation

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care (web-based 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.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Online Mindfulness Meditation; Receive web-based mindfulness meditation; Other Names: Online Mindful Meditation; Online Mindfulness-Based Stress Reduction (MBSR); Online Mindfulness Relaxation; Online MBSR; Web-Based Mindfulness Meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as assessed by evaluating recruitment rate	Number of participants approached who consent to participate	At end of enrollment (Up to 1 year)
Feasibility as assessed by evaluating rate of refusal to participate	Number of participants refusing to consent.	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.	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	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	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.	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.	At 8 weeks after study start (Up to 1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer	0 to 10, with 10 being the worst level of distress	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 a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)		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		At baseline, week 4 and week 8 after study start (Up to 1 year)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Chloe Atreya, MD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: 174534 (Integrated Research Application System); NCI-2018-00622 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No