Development of an Intervention to Enhance Cancer Pain Management

NCT03752268 | Active Not Recruiting

• 2 other identifiers: 13-614ACS MRSG 14-107-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Cancer

Keywords

Other Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Enhancing Cancer Pain Management Part 1

NO INTERVENTION

* 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

* 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

Interventions

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.

Enhancing Cancer Pain Management Part 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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\*\*

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02214, United States

Location

Study Officials

• Lara Traeger, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: April 15, 2014
• Primary Completion: November 30, 2021
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)