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Trial Title:
Study of a Rapid Triadic Communication Intention Elicitation Intervention to Improve Supportive Oncology Care Delivery
NCT ID:
NCT05995860
Condition:
Vulvar Cancer
Ovarian Cancer
Uterine Cancer
Vaginal Cancer
Conditions: Official terms:
Vulvar Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Intervention group triads
Description:
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.
Arm group label:
Intervention group triads
Other name:
PRECursOr
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IU Health Joe and Shelly Schwarz Cancer Center
Address:
City:
Carmel
Zip:
46032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lynne McCranor, BA
Phone:
317-278-4712
Email:
lmccrano@iu.edu
Investigator:
Last name:
Kristin Levoy, MD
Email:
Principal Investigator
Facility:
Name:
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristine Brannock
Phone:
317-278-0230
Email:
kbrannoc@iu.edu
Start date:
June 14, 2023
Completion date:
March 2025
Lead sponsor:
Agency:
Indiana University
Agency class:
Other
Source:
Indiana University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05995860
