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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Caregiver, Metastatic Gastrointestinal Carcinoma

Intervention / Treatment
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* Behavioral: Online Mindfulness Meditation
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (web-based mindfulness meditation)<br>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<br>* Receive web-based mindfulness meditation<br>* Other names: Online Mindful Meditation; Online Mindfulness-Based Stress Reduction (MBSR); Online Mindfulness Relaxation; Online MBSR; Web-Based Mindfulness Meditation;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) |