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

Caregiver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528863
• Other study ID #: 174534
• Secondary ID: NCI-2018-00622
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: October 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver
• Gastrointestinal Neoplasms
• Metastatic Gastrointestinal Carcinoma

Intervention

Behavioral:
• Online Mindfulness Meditation
Receive web-based mindfulness meditation

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by evaluating recruitment rate	Number of participants approached who consent to participate	At end of enrollment (Up to 1 year)
Primary	Feasibility as assessed by evaluating rate of refusal to participate	Number of participants refusing to consent.	At end of enrollment (Up to 1 year)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)