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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

Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE November 23, 2018
Last Update Posted Date May 21, 2021
Actual Study Start Date  ICMJE April 15, 2014
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of an Intervention to Enhance Cancer Pain Management
Official Title  ICMJE Development of an Intervention to Enhance Cancer Pain Management
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Other Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Enhancing Cancer Pain Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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**
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03752268
Other Study ID Numbers  ICMJE 13-614
ACS MRSG 14-107-01 ( Other Grant/Funding Number: American Cancer Society )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lara Traeger, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE American Cancer Society, Inc.
Investigators  ICMJE
Principal Investigator: Lara Traeger, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP