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

Other Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736746
• Other study ID #: 18-376
• Status: Completed
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: August 2, 2019

Study information

• Verified date: April 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain
• Other Cancer

Intervention

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)

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Sigma Theta Tau International Honor Society of Nursing

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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