Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers (Mindfulness)
Being Present: Audio-Based Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- University of California San Francisco
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Study Intervention
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.
|
Audio-based mindfulness tracks (MP3 format).
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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)
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
8 weeks
|
|
Reasons for ineligibility, as a measure of feasibility
Time Frame: 8 weeks
|
8 weeks
|
|
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
|
8 weeks
|
|
Reasons for non-participation/non-continuation of the intervention, as a measure of feasibility and acceptability
Time Frame: 8 weeks
|
8 weeks
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
Time Frame: 0, 4 and 8 weeks
|
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
Time Frame: 0, 4 and 8 weeks
|
0, 4 and 8 weeks
|
|
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
|
0, 4 and 8 weeks
|
|
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
|
0, 4 and 8 weeks
|
|
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
|
0, 4 and 8 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Chloe Atreya, MD, PhD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 15455
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Cancer
-
NCT04597151CompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
-
NCT04832763Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
-
NCT03781778TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
-
NCT04739072RecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
-
NCT03796884Active, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal Cancer AJCC v8
-
NCT03844620Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Refractory Colorectal Carcinoma
-
NCT03520283CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal Cancer AJCC v8 | Stage IIC Colorectal Cancer AJCC v8
-
NCT03800602CompletedColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal Cancer
-
NCT01570452CompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage I
-
NCT03300609TerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer AJCC v7
Clinical Trials on Audio-Based Mindfulness
-
NCT06541587RecruitingBreast Cancer | Chemotherapy | Virtual Reality | Mindfulness
-
NCT06034249CompletedQuality of Life | Caregivers of People With Dementia
-
NCT07103434Not yet recruitingDementia | Caregiver Burden of People With Dementia
-
NCT05746468Not yet recruiting
-
NCT05852795CompletedAutism Spectrum Disorder | Parents
-
NCT05054595WithdrawnPain | Osteoarthritis, Knee | Osteoarthritis, Hip
-
NCT06232382Not yet recruitingHypnosis, Mindfulness Meditation
-
NCT05590507Completed
-
NCT03797599CompletedMindfulness | Healthy Population
-
NCT01964664CompletedCerebral Palsy | Physical Impairments | Cerebral Ataxia | locked-in Syndrome