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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

Tracking Information
First Submitted Date  ICMJE November 7, 2018
First Posted Date  ICMJE November 9, 2018
Last Update Posted Date December 3, 2018
Actual Study Start Date  ICMJE November 16, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03736746 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals
Official Title  ICMJE Testing Feasibility of Motivational Interviewing for Patient-Reported Cancer Pain Goals
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Other Cancer
Intervention  ICMJE 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)
Study Arms  ICMJE 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
Intervention: Behavioral: Motivational Interviewing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2018)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Olga Ehrlich, PhD 617-582-7847 olga_ehrlich@dfci.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03736746
Other Study ID Numbers  ICMJE 18-376
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Olga Ehrlich, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE STTI-American Nurses Foundation
Investigators  ICMJE
Principal Investigator: Olga Ehrlich, PhD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP