Clinical trial · Interventional
Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers
Being Present: Audio-Based Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers
NCT02423720CI-TRIAL-00031782MindfulnesscompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Audio-Based Mindfulness | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 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 practice instructions and links to validated questionnaires.
- interventionNames
- Behavioral: Audio-Based Mindfulness
Primary outcomes (2)
- 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.
- timeFrame
- 8 weeks
- measure
- Adherence to the intervention, as assessed by frequency and duration of practicing the exercises (recorded in a log and responses to text messages)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAtreya 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