Expired Study
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San Francisco, California 94158


Purpose:

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).


Study summary:

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.


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.


Study is Available At:


Original ID:

15455


NCT ID:

NCT02423720


Secondary ID:


Study Acronym:

Mindfulness


Brief Title:

Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers


Official Title:

Being Present: Audio-Based Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

53


Enrollment Type:

Actual


Overall Contact Information

Official Name:Chloe Atreya, MD, PhD
Principal Investigator
University of California, San Francisco

Study Dates

Start Date:April 28, 2015
Completion Date:January 1, 2017
Completion Type:Actual
Primary Completion Date:May 3, 2016
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 22, 2018
First Received Date:April 17, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Reasons for non-participation/non-continuation of the intervention, as a measure of feasibility and acceptability
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Reasons for ineligibility, as a measure of feasibility
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Audio-Based Mindfulness
Description:Audio-based mindfulness tracks (MP3 format).
Arm Name:Study Intervention

Study Arms

Study Arm Type:Other
Arm Name:Study Intervention
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 prac

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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