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

NCT ID: NCT05995860

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2025-01-23

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.

Conditions

Vulvar Cancer; Ovarian Cancer; Uterine Cancer; Vaginal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control group triads

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group triads

Group Type: EXPERIMENTAL

Intervention group triads

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PRECursOr

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Kristin Levoy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

United States

Other Identifiers

CTO-IUSCCC-0827

Identifier Type: -

Identifier Source: org_study_id