Back to resultsStudy of a Rapid Triadic Communication Intention Elicitation Intervention to Improve Supportive Oncology Care Delivery (PRECursOr)
Primary Purpose
Stage III Vulvar Cancer, Stage III Ovarian Cancer, Stage III Uterine Cancer
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention group triads
Sponsored by
About this trial
This is an interventional supportive care trial for Stage III Vulvar Cancer
Eligibility Criteria
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.
Sites / Locations
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group triads
Intervention group triads
Arm Description
Outcomes
Primary Outcome Measures
Evaluate overall recruitment rates.
PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration).
Evaluate overall participant satisfaction surveys.
PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05995860
First Posted
July 10, 2023
Last Updated
August 10, 2023
Sponsor
Indiana University
Collaborators
American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05995860
Brief Title
Study of a Rapid Triadic Communication Intention Elicitation Intervention to Improve Supportive Oncology Care Delivery
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
American Cancer Society, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group triads
Arm Type
No Intervention
Arm Title
Intervention group triads
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Intervention group triads
Other Intervention Name(s)
PRECursOr
Intervention 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.
Primary Outcome Measure Information:
Title
Evaluate overall recruitment rates.
Description
PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration).
Time Frame
Once all surveys in the sample size are completed, 9 months anticipated
Title
Evaluate overall participant satisfaction surveys.
Description
PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire.
Time Frame
Once all surveys in the sample size are completed, 9 months anticipated
Title
Explore group differences in communication behaviors during the audio-recorded encounters.
Description
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.
Time Frame
Once all encounters in the sample size are completed and transcribed, 9 months anticipated
Title
Explore group differences in exit interview outcomes following the encounters.
Description
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.
Time Frame
Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated
Title
Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes
Description
Identify intervention approaches that contributed to positive and/or negative outcomes to inform intervention refinement using qualitative research methods.
Time Frame
Once all surveys in the sample size are completed, 9 months anticipated
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of a Rapid Triadic Communication Intention Elicitation Intervention to Improve Supportive Oncology Care Delivery
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