Clinical trial NCT05995860: Study of a Rapid Triadic Communication Intention Elicitation Intervention to Improve Supportive Oncology Care Delivery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvar Cancer
Ovarian Cancer
Uterine Cancer
Vaginal Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Evaluate overall recruitment rates.
timeFrame: Once all surveys in the sample size are completed, 9 months anticipated
measure: Evaluate overall participant satisfaction surveys.
timeFrame: Once all surveys in the sample size are completed, 9 months anticipated
measure: Explore group differences in communication behaviors during the audio-recorded encounters.
timeFrame: Once all encounters in the sample size are completed and transcribed, 9 months anticipated
measure: Explore group differences in exit interview outcomes following the encounters.
timeFrame: Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated
measure: Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes
timeFrame: Once all surveys in the sample size are completed, 9 months anticipated
Secondary outcomes:
Other outcomes:
Locations:
city: Carmel
country: United States
facility: IU Health Joe and Shelly Schwarz Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
Study officials:
References: