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

Primary Purpose

Other Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Other Cancer focused on measuring Other Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Motivational Interviewing

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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
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

Full Information

First Posted
November 7, 2018
Last Updated
April 15, 2022
Sponsor
Dana-Farber Cancer Institute
Collaborators
Sigma Theta Tau International Honor Society of Nursing
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1. Study Identification

Unique Protocol Identification Number
NCT03736746
Brief Title
Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals
Official Title
Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Sigma Theta Tau International Honor Society of Nursing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Cancer
Keywords
Other Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
An investigator-led discussion about the participant's pain experience which is focused on the participant reporting of functional pain goals (FPGs)
Primary Outcome Measure Information:
Title
Feasibility of Motivational Interviewing intervention
Description
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
Secondary Outcome Measure Information:
Title
Motivational Interviewing intervention usage rate
Description
The number of interventions sessions attended divided by the total possible number of interventions sessions reported as the sample mean.
Time Frame
1 year
Title
Participant intervention acceptability
Description
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
Title
Attitudinal barriers to pain
Description
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
Title
Pain Self-Efficacy
Description
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
Title
Observed engagement in goals-setting
Description
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
Time Frame
1 year
Title
Motivational Interviewing intervention fidelity
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Ehrlich, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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