Development of an Intervention to Enhance Cancer Pain Management

Long-acting opioids are a common treatment for cancer pain. The purpose of this study is to
develop a program for patients who are taking a prescribed long-acting opioid for their
cancer pain. Participants will be enrolled in this study at the Massachusetts General
Hospital Cancer Center. This 14-week study involves completing a set of questionnaires at
three different times during the study period. . During the study period, participants will
use electronic pill caps to monitor their pain medication taking. They also will attend a
series of three visits with one of the nurse practitioners on their care cancer team. The
visits will focus on learning and practicing skills for managing cancer pain. The information
that the investigators collect will help identify whether the sessions are feasible and
useful to patients during the course of treatment for cancer pain.

This trial will consist of two parts:

Part 1: This is a single-group prospective observational study. Investigators will use
quantitative and qualitative methods to examine rates, predictors and outcomes of adherence
to LA opioids over a period of approximately eight weeks. This information will be used to
inform Part 2 intervention development and testing.

Part 2: Investigators will test the behavioral intervention in a non-randomized open pilot,
over a period of approximately six weeks. Intervention process data, psychosocial and medical
data, and post-intervention feedback will be collected to assess feasibility and
acceptability. In an iterative process, ongoing data from exit interviews and therapist
experience will be used to modify the intervention protocol.

Inclusion Criteria:

- Age 21 or older

- Currently prescribed a long-acting (LA) opioid for nociceptive cancer pain (extended
release oxycodone, extended-release morphine, transdermal fentanyl patches, methadone
tablets)

- Ability to comprehend study materials in English

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- In charge of administering own pain medications

- Part 2 study only: within 4 months of current prescription of LA opioid for
nociceptive cancer pain

Exclusion Criteria:

- Impaired cognition, active substance disorder, or other active, unstable mental health
disorder

- Current long-acting opioid treatment for pre-existing condition

- Part 2 study only: Prior enrollment in the Part 1 study**