Mindfulness Meditation Intervention for Colorectal Cancer Patients and Caregivers

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.

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.