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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stage III Vulvar Cancer, Stage III Ovarian Cancer, Stage III Uterine Cancer, Stage III Vaginal Cancer, Stage IV Vulvar Cancer, Stage IV Ovarian Cancer, Stage IV Uterine Cancer, Stage IV Vaginal Cancer

Intervention / Treatment
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* Behavioral: Intervention group triads


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients will: 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), be at a transition point in the illness (provider confirmed non-response to treatment, progressive disease, or a symptomatic hospitalization within the last month), 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. Exclusion Criteria: patients and/or caregivers will be excluded if either one or both demonstrate: cognitive impairment, or speech/hearing difficulties precluding participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group triads<br> | |
| Experimental: Intervention group triads<br> | Behavioral: Intervention group triads<br>* 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.<br>* Other names: PRECursOr;|

What is the study measuring?
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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 |