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

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.

Study Overview

• Status: Completed
• Conditions: Other Cancer
• Intervention / Treatment: Behavioral: Motivational Interviewing

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Motivational Interviewing; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Sigma Theta Tau International Honor Society of Nursing
• Investigators: Principal Investigator: Olga Ehrlich, PhD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2018
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Other Cancer
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: 18-376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No