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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Caregiver
Metastatic Gastrointestinal Carcinoma

Treatments

Behavioral: Online Mindfulness Meditation
Other: Questionnaire Administration

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03528863
NCI-2018-00622 (Registry Identifier)
174534

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

68 participants in 1 patient group

Supportive Care (web-based mindfulness meditation)
Experimental group
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.
Treatment:
Other: Questionnaire Administration
Behavioral: Online Mindfulness Meditation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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