Development of an Intervention to Enhance Cancer Pain Management

Mass General Brigham

Status: Unknown

Conditions: Other Cancer

Treatments: Behavioral: Enhancing Cancer Pain Management

Study type: Interventional

Funder types: Other

Identifiers

NCT03752268

13-614

ACS MRSG 14-107-01 (Other Grant/Funding Number)

Details and patient eligibility

About

This research study is being done to understand how patients with chronic cancer pain take their long-acting opioid medications, and to develop an intervention to enhance cancer pain management.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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**

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Enhancing Cancer Pain Management Part 1

No Intervention group

Description:

* Will collect information from participants via self-report assessment at two time points: at baseline (i.e. study enrollment) and approximately 8 weeks post-baseline * Will then use MEMS to monitor LA opioid intake over approximately 8 weeks * A subset of enrolled participants (n=20) will be invited to participate in an optional one-time qualitative exit interview with a study staff member trained in conducting qualitative interviews

Enhancing Cancer Pain Management Part 2

Experimental group

Description:

* Enhancing Cancer Pain Management will consist of 3 individual manualized sessions * The 3 individual manualized sessions will be conducted (approximately 20 minutes each), led by a nurse practitioner, to provide sufficient dose for change in adherence behaviors. * Learning and practicing skills for managing cancer-related pain and adhering to prescribed LA opioid regimens. * Study staff will provide participants with MEMS caps and bottles at time of enrollment, to monitor LA opioid intake over approximately 14 weeks.

Treatment:

Behavioral: Enhancing Cancer Pain Management