Other Cancer
Conditions
Keywords
Other Cancer
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.
Interventions
BEHAVIORALEnhancing 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.
Sponsors
Massachusetts General Hospital
American Cancer Society, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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\*\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who complete study sessions | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLara Traeger, MD
Massachusetts General Hospital
Outcome results
None listed