Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers

Last updated: February 22, 2018
Sponsor: University of California, San Francisco
Overall Status: Completed

Phase

N/A

Condition

Rectal Cancer

Cancer

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT02423720
15455
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a audio based mindfulness meditation intervention for colorectal cancer patients and caregivers. A 8-week single arm study will be conducted among University of California, San Francisco (UCSF) patients with metastatic colorectal cancer undergoing chemotherapy and caregivers of these patients (44 participants total).

Eligibility Criteria

Inclusion

Inclusion Criteria: Eligible patients must:

  • Carry a diagnosis of metastatic colon, rectum, or small bowel adenocarcinoma

  • Anticipate receiving chemotherapy for at least 12 weeks total from the time ofrecruitment

  • Have life expectancy of at least 6 months

  • Have Karnofsky Performance Status ≥60

  • Be able to speak and read English

  • Have access to a mobile phone

  • Be able to navigate websites, fill out forms on the web, communicate by email, andhave regular access to the internet

  • Have a distress level of ≥3 on the NCCN Distress Thermometer (DT).[1, 40]

  • An effort will always be made to recruit patient and caregiver pairs, but unpairedpatients are also eligible Eligible caregivers are a spouse/partner, other family member, or a close friend of apatient with metastatic colon, rectum, or small bowel adenocarcinoma. Eligible caregivers must:

  • Be able to speak and read English

  • Have access to a mobile phone

  • Be able to navigate websites, fill out forms on the web, communicate by email, andhave regular access to the internet

Exclusion

Exclusion Criteria: This study is limited the study to patients with metastatic colon, rectum, or small boweladenocarcinoma, because treatment regimens and disease trajectories for these diseasegroups are similar. Deafness, Current meditation practice (>2 episodes or >1 hour total, weekly), and currentenrollment in a stress reduction program are exclusion criteria for the intervention studybecause the study is designed as an audio-based introduction to mindfulness meditation. Patients with a DT level >7 will be considered on a case-by- case basis. Patients andcaregivers who participate in a focus group and meet criteria for the intervention will begiven the opportunity to participate: data will be collected, but thesepatients/participants will not be included in the final analyses so as not to bias theresults.

Study Design

Total Participants: 53
Study Start date:
April 28, 2015
Estimated Completion Date:
January 01, 2017

Study Description

A metastatic cancer diagnosis is associated with high levels of distress in both patients and caregivers. The investigators hypothesize that an audio-based mindfulness intervention will be an effective means to reduce distress and improve quality of life among patients with advanced cancer and their caregivers. With the Being Present study, conduct an 8-week single arm study among UCSF patients with metastatic colorectal cancer undergoing chemotherapy and caregivers of these patients (44 participants total). Participants will receive an informational booklet containing a practice log and a MP3 player containing an introductory lecture and guided meditations. Practice reminders will be sent via text messages. Emails will contain practice assignments and links to validated survey instruments. The survey instruments (National Comprehensive Cancer Network (NCCN) Distress Thermometer and National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) adult short forms) will measure global health, anxiety, depression, fatigue, and sleep quality before, during, and after the intervention to obtain preliminary estimates of the efficacy of the intervention among patients and caregivers on self-reported outcomes. Qualitative data will be collected from pre- and post-intervention interviews.

Connect with a study center

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

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