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Development of an Intervention to Enhance Cancer Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03752268
Recruitment Status : Active, not recruiting
First Posted : November 23, 2018
Last Update Posted : May 21, 2021
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Lara Traeger, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Other Cancer Behavioral: Enhancing Cancer Pain Management Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development of an Intervention to Enhance Cancer Pain Management
Actual Study Start Date : April 15, 2014
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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**
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752268


Locations
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United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Massachusetts General Hospital
American Cancer Society, Inc.
Investigators
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Principal Investigator: Lara Traeger, MD Massachusetts General Hospital
More Information
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Responsible Party: Lara Traeger, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03752268    
Other Study ID Numbers: 13-614
ACS MRSG 14-107-01 ( Other Grant/Funding Number: American Cancer Society )
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lara Traeger, Massachusetts General Hospital:
Other Cancer
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations