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

K
Kristin Levoy

Primary Investigator

Enrolling By Invitation
18-100 years
Female
Phase N/A
40 participants needed
1 Location

Brief description of study

What is this study about?
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 participants' reaction to this idea in order to understand needed changes before we introduce the idea to a larger group of patients.

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.

We are interested in developing new ways to enhance the communication that occurs during clinic appointments as well as understanding how this communication influences patients and caregivers overall care experience and well-being.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential patients will be identified in the IUSCCC gynecology oncology outpatient clinics and will be approached by the research staff about study participation. Caregivers will be identified through the patients and also screened for eligibility utilizing the eligibility criteria and will under the informed consent process (either in person or by phone) if they express interest in the study. The gynecologic oncology providers (which includes 5 physician and 2 nurse practitioner providers) that staff the gynecology oncology clinics at IUSCCC will be consented up front before patient and caregiver recruitment begins.

Interested in participating?  For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What happens during study participation?
  • Participation involves the one-time collection of information that will occur at the participant's next regularly scheduled appointment at the gynecologic oncology clinic at IU Simon Comprehensive Cancer Center. 
  • Both the participant and the primary caregiver will participate (the primary caregiver is the individual the patient identifies is primarily involved in their healthcare and may be a spouse/partner, family member, friend, or neighbor). 
  • Participants and their primary caregiver will be asked to do three things:
  1. Consent to audio-recording your next clinic appointment with your gynecologic oncology provider
  2. Complete surveys following the appointment, which would take approximately 30 minutes.
  3. Participate in an audio-recorded interview about your appointment that day, which would take approximately 10 minutes
  • Total time for participating in this study would be approximately one hour.

Additional information
The study is being conducted by Kristin Levoy, PhD, MSN, RN, OCN, CNE and Indiana University School of Nursing. It is funded by Indiana University and the American Cancer Society.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ovarian Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Female

Inclusion Criteria:
Participants
  • 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)
  • Must not be receiving specialty palliative care or hospice
  • Able to read/speak English
  • Able to provide written informed consent
Caregivers
  • Identify as the individual who is primarily involved in the patient’s care
  • Must be able to attend the oncology encounter
  • Able to read/speak English
  • Able to provide written informed consent
Providers
  • Specialize in gynecologic oncology
  • Must provide outpatient care at IUSCCC gynecologic oncology clinic
Exclusion criteria:
  • Participants and/or caregivers will be excluded if either one or both demonstrate cognitive impairment or speech/hearing difficulties

Updated on 28 Sep 2024. Study ID: CTO-IUSCCC-0827, 18860
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