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

Stage IV Ovarian Cancer Clinical Trial

— PRECursOr  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05995860
• Other study ID #: CTO-IUSCCC-0827
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients will:

1. be adult women with an advanced, incurable gynecologic cancer (Stage III/IV disease at diagnosis combined with evidence of refractory/progressive disease after first-line treatment or recurrent disease),

2. be at a transition point in the illness (provider confirmed non-response to treatment, progressive disease, or a symptomatic hospitalization within the last month),

3. not be receiving specialty palliative care or hospice,

4. read/speak English, and

5. 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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Stage III Ovarian Cancer
• Stage III Vaginal Cancer
• Stage III Vulvar Cancer
• Stage IV Ovarian Cancer
• Stage IV Vulvar Cancer
• Uterine Neoplasms
• Vaginal Neoplasms
• Vulvar Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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