Development of an Intervention to Enhance Cancer Pain Management

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Other Cancer
• Intervention / Treatment: Behavioral: Enhancing 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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02214
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Enhancing Cancer Pain Management Part 1; 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
Experimental: Enhancing Cancer Pain Management Part 2; 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.	Behavioral: Enhancing Cancer Pain Management; Patients will learn and practice an enduring framework of cognitive-behavioral strategies, to enhance adherence behavior, reduce intentional and unintentional deviations from the prescribed regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who complete study sessions	Proportion of enrolled participants who complete the study, based on a criterion of greater than or equal to 75% completed sessions.	2 Years
Number of participants who identify study components as acceptable	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.	2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Lara Traeger, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2014
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Other Cancer
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: 13-614; ACS MRSG 14-107-01 (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No