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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528863
Recruitment Status : Active, not recruiting
First Posted : May 18, 2018
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Caregiver Metastatic Gastrointestinal Carcinoma Behavioral: Online Mindfulness Meditation Other: Questionnaire Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Being Present 2.0: Web-Based Mindfulness Meditation for Gastrointestinal Cancer Patients and Caregivers
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : February 28, 2019
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.
Behavioral: Online Mindfulness Meditation
Receive web-based mindfulness meditation
Other Name: Online Mindful Meditation; Online Mindfulness-Based Stress Reduction (MBSR); Online Mindfulness Relaxation; Online MBSR; Web-Based Mindfulness Meditation

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Feasibility as assessed by evaluating recruitment rate [ Time Frame: At end of enrollment (Up to 1 year) ]
    Number of participants approached who consent to participate

  2. Feasibility as assessed by evaluating rate of refusal to participate [ Time Frame: At end of enrollment (Up to 1 year) ]
    Number of participants refusing to consent.

  3. Feasibility as assessed by rate of attrition [ Time Frame: At 8 weeks post end of enrollment (Up to 1 year) ]
    Number of participants dropping out after start of intervention for any reason.

  4. Acceptability as assessed by adherence to practice instructions [ Time Frame: At 8 weeks after study start (Up to 1 year) ]
    Number of times participant practices during study, documented via website data capture

  5. Acceptability as assessed by adherence to practice instructions [ Time Frame: At 8 weeks after study start (Up to 1 year) ]
    Number of times participant watches recorded webinars, documented via website data capture

  6. Acceptability as assessed by adherence to practice instructions [ Time Frame: At 8 weeks after study start (Up to 1 year) ]
    Number of times patient participates in live webinars, documented via roll-call.

  7. Acceptability as assessed by adherence to practice instructions [ Time Frame: 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 :
  1. Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer [ Time Frame: 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

  2. 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) ]
  3. 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) ]
  4. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528863


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Genentech, Inc.
Investigators
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Principal Investigator: Chloe Atreya University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03528863    
Other Study ID Numbers: 174534
NCI-2018-00622 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases