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

NCT05995860 | Completed DMC

• 1 other identifier: CTO-IUSCCC-0827
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Vulvar Cancer; Ovarian Cancer; Uterine Cancer; Vaginal Cancer

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Control group triads

NO INTERVENTION

Intervention group triads

EXPERIMENTAL

Behavioral: Intervention group triads

Interventions

Intervention group triads 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.

Also known as: PRECursOr

Intervention group triads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• providers will:
• specialize in gynecologic oncology, and
• provide outpatient care at IUSCCC gynecologic oncology clinic.

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032, United States

Location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Vulvar Neoplasms; Ovarian Neoplasms; Uterine Neoplasms; Vaginal Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Vaginal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 16, 2023
• Study Start: June 14, 2023
• Primary Completion: January 9, 2025
• Study Completion: January 23, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)