NCT03736746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

November 16, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

November 7, 2018

Last Update Submit

April 15, 2022

Conditions

Keywords

Other Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Motivational Interviewing intervention usage rate

    1 year

  • Participant intervention acceptability

    1 year

  • Attitudinal barriers to pain

    1 year

  • Pain Self-Efficacy

    1 year

  • Observed engagement in goals-setting

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Motivational Interviewing

EXPERIMENTAL

* 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

Interventions

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

Motivational Interviewing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18-years of age
  • Has an appointment with DFCI ambulatory palliative care service for cancer-related pain
  • Can speak English

You may not qualify if:

  • Diagnosis of delirium or other cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Olga Ehrlich, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 9, 2018

Study Start

November 16, 2018

Primary Completion

August 2, 2019

Study Completion

August 2, 2019

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations