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

Primary Purpose

Caregiver, Metastatic Gastrointestinal Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Mindfulness Meditation
Questionnaire Administration
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (web-based mindfulness meditation)

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility as assessed by evaluating recruitment rate
Number of participants approached who consent to participate
Feasibility as assessed by evaluating rate of refusal to participate
Number of participants refusing to consent.
Feasibility as assessed by rate of attrition
Number of participants dropping out after start of intervention for any reason.
Acceptability as assessed by adherence to practice instructions
Number of times participant practices during study, documented via website data capture
Acceptability as assessed by adherence to practice instructions
Number of times participant watches recorded webinars, documented via website data capture
Acceptability as assessed by adherence to practice instructions
Number of times patient participates in live webinars, documented via roll-call.
Acceptability as assessed by adherence to practice instructions
Average duration of meditation session (measured in minutes), documented via website data capture.

Secondary Outcome Measures

Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
0 to 10, with 10 being the worst level of distress
Efficacy as assessed by National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS)
Efficacy as assessed by a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)
Efficacy as assessed by a "Are You at Peace?" one-item spiritual probe

Full Information

First Posted
April 30, 2018
Last Updated
October 8, 2020
Sponsor
University of California, San Francisco
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03528863
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Genentech, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver, Metastatic Gastrointestinal Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (web-based mindfulness meditation)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Mindfulness Meditation
Other Intervention Name(s)
Online Mindful Meditation; Online Mindfulness-Based Stress Reduction (MBSR); Online Mindfulness Relaxation; Online MBSR; Web-Based Mindfulness Meditation
Intervention Description
Receive web-based mindfulness meditation
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility as assessed by evaluating recruitment rate
Description
Number of participants approached who consent to participate
Time Frame
At end of enrollment (Up to 1 year)
Title
Feasibility as assessed by evaluating rate of refusal to participate
Description
Number of participants refusing to consent.
Time Frame
At end of enrollment (Up to 1 year)
Title
Feasibility as assessed by rate of attrition
Description
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)
Title
Acceptability as assessed by adherence to practice instructions
Description
Number of times participant practices during study, documented via website data capture
Time Frame
At 8 weeks after study start (Up to 1 year)
Title
Acceptability as assessed by adherence to practice instructions
Description
Number of times participant watches recorded webinars, documented via website data capture
Time Frame
At 8 weeks after study start (Up to 1 year)
Title
Acceptability as assessed by adherence to practice instructions
Description
Number of times patient participates in live webinars, documented via roll-call.
Time Frame
At 8 weeks after study start (Up to 1 year)
Title
Acceptability as assessed by adherence to practice instructions
Description
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)
Secondary Outcome Measure Information:
Title
Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
Description
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)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chloe Atreya, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35174001
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.
Results Reference
derived

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

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