Mindfulness to Enhance Quality of Life and Support Advance Care Planning

Mindfulness meditation practices have reduced emotional distress, avoidant coping, and
improved spiritual well-being in adult cancer patients. These beneficial effects may occur
through present-moment acceptance of unpleasant thoughts, feelings, and circumstances and
adaptive coping through self-awareness, self-regulation, and self-transcendence. Most
mindfulness trials in cancer have focused on early-stage survivors; however, preliminary
evidence suggests that mindfulness may help reduce distress in patients with advanced cancer
and their family caregivers (FCGs).

Sixty patients with an advanced-stage solid malignancy and their FCGs (60 dyads) will be
randomized in equal numbers to receive either the 6-week mindfulness intervention or usual
care. Both groups will receive standard cancer care throughout the study period. Dyads
randomized to the mindfulness arm will learn mindfulness meditation practices (e.g., body
scan, sitting meditation) and mindful communication practices to enhance quality of life,
support advance care planning engagement, and improve a variety of secondary outcomes.

The study will use a mixed methods 2-arm randomized design to examine the effects of the
mindfulness intervention compared to usual care and seek to explain trial results using
insights gleaned from post-intervention qualitative interviews.

Inclusion Criteria—Patients

- Patient is at least 18 years of age.

- Patient is at least 3 weeks post-diagnosis of an incurable (locally advanced or
metastatic) solid malignancy.

- Patient's attending medical oncologist would not be surprised if the patient died in
the next 12 months.

- Patient has not completed a POST form.

- Patient scores ≥ 7 on the Mini-Mental Adjustment to Cancer cognitive avoidance
subscale.

- Patient is willing and able to consent and travel to the class location for 6 weekly
2-hour sessions.

- Patient has a family member or close friend eligible and interested in participating
in the study.

- Patient has adequate English fluency for completion of data collection

Inclusion Criteria—Family Care Givers (FCG)

- FCG is at least 18 years of age.

- FCG has been invited to participate in the trial with a patient who meets eligibility
criteria above.

- FCG is willing and able to consent and travel to the class location for 6 weekly
2-hour sessions.

- FCG has adequate English fluency for completion of data collection

Exclusion Criteria—Patients

- Patient reports a score of > 2 on the Activities and Function item from the Patient
Generated Subjective Global Assessment91 (PG-SGA; the patient-reported version of the
Eastern Cooperative Oncology Group score).

- Patient makes 3 or more errors on a validated 6-item cognitive screener or exhibits
significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation,
active psychosis) that in the judgment of the investigators would preclude providing
informed consent and study participation.

- Currently receiving hospice care (patients who enroll in hospice during the trial will
have the option of continuing trial participation).

Exclusion Criteria—FCGs

• FCG exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium,
retardation, active psychosis) that in the judgment of the investigators would preclude
providing informed consent and study participation.