Development of an Intervention to Enhance Cancer Pain Management

Not Applicable

• Conditions: Other Cancer
• Interventions: Behavioral: Enhancing Cancer Pain Management

• Registration Number: NCT03752268
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-04-15
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-21
• Primary Completion: 2021-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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**

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhancing Cancer Pain Management Part 2	Enhancing Cancer Pain Management	* 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.

Primary Outcome Measures

Name	Time	Method
Number of participants who identify study components as acceptable	2 years	Individual response frequencies of 4 Likert-type scale items, designed for this study, that rate acceptability of 1) number of study sessions, 2) length of study sessions, 3) usefulness of study material, and 4) impact of study material on pain management, and themes of two free-text items that elicit unstructured participant feedback about acceptability of these study components.
Number of participants who complete study sessions	2 Years	Proportion of enrolled participants who complete the study, based on a criterion of greater than or equal to 75% completed sessions.

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States