Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals

Conditions
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Other Cancer

Intervention / Treatment
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* Behavioral: Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18-years of age Has an appointment with DFCI ambulatory palliative care service for cancer-related pain Can speak English Exclusion Criteria: -Diagnosis of delirium or other cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br>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<br>* An investigator-led discussion about the participant's pain experience which is focused on the participant reporting of functional pain goals (FPGs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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: pain as an obstacle what helped pain before life with controlled pain suggestions to control pain suggestions actually used help-seeking | 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: Motivational Interviewing philosophy health interviewing motivation Motivational Interviewing principles interpersonal process Each domain has specific behaviors that are rated as: deficient developing accomplished not applicable | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Other Cancer