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Completed

NCT Number: NCT03736746

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.

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Key information

Conditions

Other Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

An investigator-led discussion about the participant's pain experience which is focused on the participant reporting of functional pain goals (FPGs)

Primary outcomes

  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 outcomes

  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:

    • pain as an obstacle
    • what helped pain before
    • life with controlled pain
    • suggestions to control pain
    • suggestions actually used
    • 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:

    • 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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Sigma Theta Tau International Honor Society of Nursing

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2018
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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