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OpenTrials
Active, Not Recruiting

NCT Number: NCT03752268

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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**

Treatment and study plan

Enhancing Cancer Pain Management

Behavioral

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.

Primary outcomes

  1. Number of participants who complete study sessions

    Time frame: 2 Years

    Proportion of enrolled participants who complete the study, based on a criterion of greater than or equal to 75% completed sessions.

  2. Number of participants who identify study components as acceptable

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2026
First posted
Nov 23, 2018
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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