Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02214, United States
NCT Number: NCT03752268
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.
This study is active but is not currently recruiting participants.
21 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02214, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Massachusetts General Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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