NCT03528863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

April 30, 2018

Last Update Submit

October 8, 2020

Conditions

CaregiverMetastatic Gastrointestinal Carcinoma

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (4)

  • Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer

    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)

Study Arms (1)

Supportive Care (web-based mindfulness meditation)

EXPERIMENTAL

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 MeditationOther: Questionnaire Administration

Interventions

Online Mindfulness MeditationBEHAVIORAL

Receive web-based mindfulness meditation

Also known as: Online Mindful Meditation; Online Mindfulness-Based Stress Reduction (MBSR); Online Mindfulness Relaxation; Online MBSR; Web-Based Mindfulness Meditation
Supportive Care (web-based mindfulness meditation)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive Care (web-based mindfulness meditation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • 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.

    PMID: 35174001DERIVED

Study Officials

  • Chloe Atreya, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 18, 2018

Study Start

May 7, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

October 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)