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Clinical Trials/NCT05995860
NCT05995860
Completed
N/A

Pilot Study of a Rapid Triadic Communication Intention Elicitation Intervention (PRECursOr) to Improve Supportive Oncology Care Delivery for Patients with Advanced, Incurable Cancer and Their Caregivers

Indiana University2 sites in 1 country47 target enrollmentJune 14, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vulvar Cancer
Sponsor
Indiana University
Enrollment
47
Locations
2
Primary Endpoint
Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to help test an idea designed to foster more supportive talk between providers (doctors or nurse practitioners), patients, and caregivers during an outpatient oncology appointment. A caregiver is the person the patient identifies is primarily involved in their healthcare. This study is collecting your reaction to this idea in order to understand needed changes before we introduce the idea to a larger group of patients.

Detailed Description

This pilot study focuses on an intervention (freelisting) designed to elicit supportive oncology communication intentions among the patient-caregiver-provider triad prior to an outpatient oncology encounter. The goal is to shape communication behaviors during the encounter to improve outcomes of the encounter.

Registry
clinicaltrials.gov
Start Date
June 14, 2023
End Date
January 23, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kristin Levoy

Assistant Professor

Indiana University

Eligibility Criteria

Inclusion Criteria

  • patients will:
  • be adult women with an incurable gynecologic cancer (i.e., evidence of refractory/progressive disease after first-line treatment or recurrent disease),
  • not be receiving specialty palliative care or hospice,
  • read/speak English, and
  • be able to provide written informed consent.
  • caregivers will:
  • identify as the individual who is primarily involved in the patient's care,
  • be able to attend the oncology encounter,
  • read/speak English, and
  • be able to provide written informed consent.

Exclusion Criteria

  • patients and/or caregivers will be excluded if either one or both demonstrate:
  • cognitive impairment, or
  • speech/hearing difficulties precluding participation.

Outcomes

Primary Outcomes

Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes

Time Frame: Once all surveys in the sample size are completed, 9 months anticipated

Identify intervention approaches that contributed to positive and/or negative outcomes to inform intervention refinement using qualitative research methods.

Evaluate overall participant satisfaction surveys.

Time Frame: Once all surveys in the sample size are completed, 9 months anticipated

PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire.

Explore group differences in exit interview outcomes following the encounters.

Time Frame: Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated

The intervention group will demonstrate increased communication behaviors and a trend toward greater benefits in the immediate (e.g., quality of communication) and proximal (e.g., shared understanding of treatment goals, distress, anxiety) outcomes of communication.

Evaluate overall recruitment rates.

Time Frame: Once all surveys in the sample size are completed, 9 months anticipated

PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration).

Explore group differences in communication behaviors during the audio-recorded encounters.

Time Frame: Once all encounters in the sample size are completed and transcribed, 9 months anticipated

The intervention group will demonstrate increased communication behaviors during the encounter (i.e., breadth of supportive oncology domains discussed) and a trend toward greater benefits in the immediate (e.g., quality of communication) and proximal (e.g., shared understanding of treatment goals, distress, anxiety) outcomes of communication.

Study Sites (2)

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