Development of an Intervention to Enhance Cancer Pain Management

NCT ID: NCT03752268

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-15
• Study Completion Date: 2022-11-30

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.

Conditions

Other Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Enhancing Cancer Pain Management

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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**

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lara Traeger

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lara Traeger, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

ACS MRSG 14-107-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

13-614

Identifier Type: -

Identifier Source: org_study_id