Caregiver, Metastatic Gastrointestinal Carcinoma
Conditions
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.
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.
Interventions
BEHAVIORALOnline Mindfulness Meditation
Receive web-based mindfulness meditation
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Genentech, Inc.
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability as assessed by adherence to practice instructions | At 8 weeks after study start (Up to 1 year) | Number of times participant practices during study, documented via website data capture |
| Feasibility as assessed by evaluating recruitment rate | At end of enrollment (Up to 1 year) | Number of participants approached who consent to participate |
| Feasibility as assessed by evaluating rate of refusal to participate | At end of enrollment (Up to 1 year) | Number of participants refusing to consent. |
| Feasibility as assessed by rate of attrition | At 8 weeks post end of enrollment (Up to 1 year) | Number of participants dropping out after start of intervention for any reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 0 to 10, with 10 being the worst level of distress |
| 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) | — |
Countries
United States
Outcome results
None listed