Back to resultsMindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers (Mindfulness)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audio-Based Mindfulness
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer
Eligibility Criteria
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 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
Exclusion Criteria:
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.
Deafness, Current meditation practice (>2 episodes or >1 hour total, weekly), and current enrollment in a stress reduction program are exclusion criteria for the intervention study because 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 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.
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Adherence to the intervention, as assessed by frequency and duration of practicing the exercises (recorded in a log and responses to text messages)
Secondary Outcome Measures
Reasons for ineligibility, as a measure of feasibility
Proportion of enrolled patients and caregivers who refuse to participate in or complete the intervention, as a measure of feasibility and acceptability
Reasons for non-participation/non-continuation of the intervention, as a measure of feasibility and acceptability
Adherence to the intervention, as assessed by frequency and duration of practicing the exercises (recorded in a log and responses to text messages)
Full Information
NCT ID
NCT02423720
First Posted
April 17, 2015
Last Updated
February 22, 2018
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02423720
Brief Title
Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers
Acronym
Mindfulness
Official Title
Being Present: Audio-Based Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 28, 2015 (Actual)
Primary Completion Date
May 3, 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Audio-Based Mindfulness
Intervention Description
Audio-based mindfulness tracks (MP3 format).
Primary Outcome Measure Information:
Title
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.
Time Frame
8 weeks
Title
Adherence to the intervention, as assessed by frequency and duration of practicing the exercises (recorded in a log and responses to text messages)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Reasons for ineligibility, as a measure of feasibility
Time Frame
8 weeks
Title
Proportion of enrolled patients and caregivers who refuse to participate in or complete the intervention, as a measure of feasibility and acceptability
Time Frame
8 weeks
Title
Reasons for non-participation/non-continuation of the intervention, as a measure of feasibility and acceptability
Time Frame
8 weeks
Title
Adherence to the intervention, as assessed by frequency and duration of practicing the exercises (recorded in a log and responses to text messages)
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Quality of life, as assessed by NIH PROMIS instruments at the beginning, midpoint and end of the study
Time Frame
0, 4 and 8 weeks
Title
Distress, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study
Time Frame
0, 4 and 8 weeks
Title
Anxiety, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study
Time Frame
0, 4 and 8 weeks
Title
Depression, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study
Time Frame
0, 4 and 8 weeks
Title
Fatigue, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study
Time Frame
0, 4 and 8 weeks
Title
Sleep quality, as assessed by NCCN Distress Thermometer and NIH PROMIS instruments at the beginning, midpoint and end of the study
Time Frame
0, 4 and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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
Exclusion Criteria:
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.
Deafness, Current meditation practice (>2 episodes or >1 hour total, weekly), and current enrollment in a stress reduction program are exclusion criteria for the intervention study because 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chloe Atreya, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30036361
Citation
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.
Results Reference
derived
Learn more about this trial
Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers
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