An interventional study of Motivational Interviewing in Other Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care
This research study is evaluating the acceptability and feasibility of using a cognitive behavioral intervention called Motivational Interviewing to help persons with pain from cancer set goals for managing that pain.
This study is being conducted to evaluate a new way that clinicians can help identify the goals that cancer participants have for managing their pain. This new method uses discussion between a patient and a clinician, in this case a registered nurse, during which one or more goals may be set. At this time, there are no tested methods that clinicians can use for helping patients set these kinds of goals.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's enrollment of 54 is close to the median of 60 across 254 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-Diagnosis of delirium or other cognitive impairment
* Will entail two-to-four Motivational Interviewing sessions per participant * Will include a battery of questionnaires * Investigator-led discussion about the participant's pain experience which is focused on the participant reporting of functional pain goals (FPGs). * The investigator will elicit questions and goals that participants will be encouraged to discuss with their palliative care providers
Behavioral: Motivational Interviewing
An investigator-led discussion about the participant's pain experience which is focused on the participant reporting of functional pain goals (FPGs)
Feasibility of Motivational Interviewing intervention
The proportion of enrolled participants completing at least one follow-up Motivational Interviewing session (at least two sessions total). The proportion of participants completing at least one follow-up intervention session will be estimated along with an exact 90% confidence interval.
Time frame: 1 year
Motivational Interviewing intervention usage rate
The number of interventions sessions attended divided by the total possible number of interventions sessions reported as the sample mean.
Time frame: 1 year
Participant intervention acceptability
The Participant Experience Questionnaire, developed by the investigator, will be used to summarize overall patient-reported acceptability in this study. Summary measures of median/range and mean/SD for total categorical scores, the time in weeks from the initial to follow-up intervention visit, and the number of completed intervention sessions will be reported.
Time frame: 1 year
Attitudinal barriers to pain
Attitudinal barriers to pain management will be measured using the Barriers Questionnaire-II which measures four attitudinal realms with 27 self-rated questions about pain beliefs. The total score will be calculated at study entry and after the first follow-up visit and scores will be summarized (median/range, mean/SD). If additional sessions are completed, the scores will be plotted over time and trends will be explored with graphical methods.
Time frame: 1 year
Pain Self-Efficacy
Pain self-efficacy will be measured using the Pain Self-Efficacy Questionnaire in which participants rate their confidence in daily living activities despite pain using a Likert-type scale.The total score will be calculated at study entry and after the first follow-up visit and scores will be summarized (median/range, mean/SD). If additional sessions are completed, the scores will be plotted over time and trends will be explored with graphical methods.
Time frame: 1 year
Observed engagement in goals-setting
Observed engagement will be evaluated using the instrument developed by the investigator for this study in which discussions of behaviors indicating active goal setting will be tabulated and salient quotes will be extracted for dissemination. Categories are: 1. pain as an obstacle 2. what helped pain before 3. life with controlled pain 4. suggestions to control pain 5. suggestions actually used 6. help-seeking
Time frame: 1 year
Motivational Interviewing intervention fidelity
Fidelity to Motivational Interviewing methods will be assessed on 33% of interviews using the Motivational Interviewing Skills for Health Care Encounters which is used to evaluate the degree to which the person providing the intervention follows five domains key to Motivational Interviewing.The domains are: 1. Motivational Interviewing philosophy 2. health interviewing 3. motivation 4. Motivational Interviewing principles 5. interpersonal process Each domain has specific behaviors that are rated as: 1. deficient 2. developing 3. accomplished 4. not applicable
Time frame: 1 year
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Dana-Farber Cancer Institute