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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Other Cancer||Behavioral: Enhancing Cancer Pain Management||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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|
No Intervention: Enhancing Cancer Pain Management Part 1
Experimental: Enhancing Cancer Pain Management Part 2
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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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**
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
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02214|
|Principal Investigator:||Lara Traeger, MD||Massachusetts General Hospital|
|Responsible Party:||Lara Traeger, Principal Investigator, Massachusetts General Hospital|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|