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Completed

NCT Number: NCT02423720

Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Audio-Based Mindfulness

Behavioral

Audio-based mindfulness tracks (MP3 format).

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Reasons for ineligibility, as a measure of feasibility

    Time frame: 8 weeks

  2. 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

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

    Time frame: 8 weeks

  4. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: Mindfulness

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 22, 2015
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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