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

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ClinicalTrials.gov Identifier: NCT03736746
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
STTI-American Nurses Foundation
Information provided by (Responsible Party):
Olga Ehrlich, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Other Cancer Behavioral: Motivational Interviewing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 31, 2019

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)




Primary Outcome Measures :
  1. Feasibility of Motivational Interviewing intervention [ Time Frame: 1 year ]
    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 :
  1. Motivational Interviewing intervention usage rate [ Time Frame: 1 year ]
    The number of interventions sessions attended divided by the total possible number of interventions sessions reported as the sample mean.

  2. Participant intervention acceptability [ Time Frame: 1 year ]
    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.

  3. Attitudinal barriers to pain [ Time Frame: 1 year ]
    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.

  4. Pain Self-Efficacy [ Time Frame: 1 year ]
    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.

  5. Observed engagement in goals-setting [ Time Frame: 1 year ]

    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

  6. Motivational Interviewing intervention fidelity [ Time Frame: 1 year ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736746


Contacts
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Contact: Olga Ehrlich, PhD 617-582-7847 olga_ehrlich@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Olga Ehrlich, PhD    617-582-7847    olga_ehrlich@dfci.harvard.edu   
Principal Investigator: Olga Ehrlich, PhD         
Principal Investigator: Donna L Berry, PhD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
STTI-American Nurses Foundation
Investigators
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Principal Investigator: Olga Ehrlich, PhD Dana-Farber Cancer Institute

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Responsible Party: Olga Ehrlich, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03736746     History of Changes
Other Study ID Numbers: 18-376
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Olga Ehrlich, Dana-Farber Cancer Institute:
Other Cancer

Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms