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

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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer; Vulvar Cancer; Vaginal Cancer; Uterine Cancer
• Intervention / Treatment: Behavioral: Intervention group triads

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46032
      • IU Health Joe and Shelly Schwarz Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group triads
Experimental: Intervention group triads	Behavioral: Intervention group triads; The intervention consists of a rapid (less than 10-minute) communication intention elicitation exercise (via Freelisting), which is conducted independently with the patient, caregiver, and provider immediately prior to the outpatient oncology encounter. Patients, caregivers, and providers will not be instructed to endorse the Freelist responses that were generated by the intervention prior to the outpatient encounter-leaving the decision to discuss elicited communication intentions during the encounter up to individuals as the conversation naturally occurs. As with the control group, post-encounter survey data will also be collected independently from the patient, caregiver, and the provider, followed by a post-encounter qualitative interview conducted jointly with the patient and caregiver.; Other Names: PRECursOr

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate overall recruitment rates.	PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration).	Once all surveys in the sample size are completed, 9 months anticipated
Evaluate overall participant satisfaction surveys.	PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire.	Once all surveys in the sample size are completed, 9 months anticipated
Explore group differences in communication behaviors during the audio-recorded encounters.	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.	Once all encounters in the sample size are completed and transcribed, 9 months anticipated
Explore group differences in exit interview outcomes following the encounters.	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.	Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated
Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes	Identify intervention approaches that contributed to positive and/or negative outcomes to inform intervention refinement using qualitative research methods.	Once all surveys in the sample size are completed, 9 months anticipated

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: American Cancer Society, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Actual): January 9, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Vulvar Diseases; Vaginal Diseases; Vulvar Neoplasms; Uterine Neoplasms; Vaginal Neoplasms
• Other Study ID Numbers: CTO-IUSCCC-0827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No