Study of a Rapid Triadic Communication Intention Elicitation Intervention to Improve Supportive Oncology Care Delivery

Not Applicable

Completed

• Conditions: Vulvar Cancer; Ovarian Cancer; Uterine Cancer; Vaginal Cancer
• Interventions: Behavioral: Intervention group triads

• Registration Number: NCT05995860
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study Start: 2023-06-14
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-08-10
• Study First Posted: 2023-08-16
• Status Verified: 2025-01
• Primary Completion: 2025-01-09
• Study Completion: 2025-01-23
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• patients will:

  1. be adult women with an incurable gynecologic cancer (i.e., evidence of refractory/progressive disease after first-line treatment or recurrent disease),
  2. not be receiving specialty palliative care or hospice,
  3. read/speak English, and
  4. be able to provide written informed consent.

• caregivers will:

  1. identify as the individual who is primarily involved in the patient's care,
  2. be able to attend the oncology encounter,
  3. read/speak English, and
  4. be able to provide written informed consent.

• providers will:

  1. specialize in gynecologic oncology, and
  2. provide outpatient care at IUSCCC gynecologic oncology clinic.

Exclusion Criteria

patients and/or caregivers will be excluded if either one or both demonstrate:

1. cognitive impairment, or
2. speech/hearing difficulties precluding participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group triads	Intervention group triads	-

Primary Outcome Measures

Name	Time	Method
Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes	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.	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.	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.	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.	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.

Trial Locations

Locations (2)

IU Health Joe and Shelly Schwarz Cancer Center; 🇺🇸 Carmel, Indiana, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States