Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers

NCT02423720 | Completed DMC

• 1 other identifier: 15455
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Proportion of eligible patients and caregivers who agree to be screened, consent to participate, and complete or partially complete the intervention, as a measure of feasibility and acceptability.

  8 weeks

• Adherence to the intervention, as assessed by frequency and duration of practicing the exercises (recorded in a log and responses to text messages)

  8 weeks

Secondary Outcomes (4)

• Reasons for ineligibility, as a measure of feasibility

  8 weeks

• Proportion of enrolled patients and caregivers who refuse to participate in or complete the intervention, as a measure of feasibility and acceptability

  8 weeks

• Reasons for non-participation/non-continuation of the intervention, as a measure of feasibility and acceptability

  8 weeks

• Adherence to the intervention, as assessed by frequency and duration of practicing the exercises (recorded in a log and responses to text messages)

  8 weeks

Other Outcomes (6)

• Quality of life, as assessed by NIH PROMIS instruments at the beginning, midpoint and end of the study

  0, 4 and 8 weeks

• Distress, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study

  0, 4 and 8 weeks

• Anxiety, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study

  0, 4 and 8 weeks

Study Arms (1)

Study Intervention

OTHER

Audio-based mindfulness intervention A 8-week single arm pilot study will be conducted among Helen Diller Famiily Comprehensive Cancer Center (HDFCCC) patients with metastatic colorectal cancer receiving chemotherapy and their caregivers (44 participants, total). Participants will receive an informational booklet containing a practice log and an MP3 player containing an introductory lecture and guided meditations. Practice reminders will be sent via text messages. Weekly emails will contain practice instructions and links to validated questionnaires.

Behavioral: Audio-Based Mindfulness

Interventions

Audio-Based Mindfulness BEHAVIORAL

Audio-based mindfulness tracks (MP3 format).

Study Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 of recruitment
• 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, and have 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 unpaired patients are also eligible
• Eligible caregivers are a spouse/partner, other family member, or a close friend of a patient 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, and have regular access to the internet

You may not qualify if:

• This study is limited the study to patients with metastatic colon, rectum, or small bowel adenocarcinoma, because treatment regimens and disease trajectories for these disease groups are similar.
• Patients with a DT level \>7 will be considered on a case-by- case basis. Patients and caregivers who participate in a focus group and meet criteria for the intervention will be given the opportunity to participate: data will be collected, but these patients/participants will not be included in the final analyses so as not to bias the results.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (1)

• Atreya CE, Kubo A, Borno HT, Rosenthal B, Campanella M, Rettger JP, Joseph G, Allen IE, Venook AP, Altschuler A, Dhruva A. Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers. PLoS One. 2018 Jul 23;13(7):e0199423. doi: 10.1371/journal.pone.0199423. eCollection 2018.

  PMID: 30036361 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Chloe Atreya, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 22, 2015
• Study Start: April 28, 2015
• Primary Completion: May 3, 2016
• Study Completion: January 1, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

US (1)