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

Sponsor
Indiana University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05995860
Collaborator
American Cancer Society, Inc. (Other)
60
1
2
8.6
7

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Jun 14, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group triads

Experimental: Intervention group triads

Behavioral: Intervention group triads
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.
Other Names:
  • PRECursOr
  • Outcome Measures

    Primary Outcome Measures

    1. Evaluate overall recruitment rates. [Once all surveys in the sample size are completed, 9 months anticipated]

      PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration).

    2. Evaluate overall participant satisfaction surveys. [Once all surveys in the sample size are completed, 9 months anticipated]

      PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire.

    3. Explore group differences in communication behaviors during the audio-recorded encounters. [Once all encounters in the sample size are completed and transcribed, 9 months anticipated]

      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.

    4. Explore group differences in exit interview outcomes following the encounters. [Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated]

      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.

    5. Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes [Once all surveys in the sample size are completed, 9 months anticipated]

      Identify intervention approaches that contributed to positive and/or negative outcomes to inform intervention refinement using qualitative research methods.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients will:
    1. 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),

    2. be at a transition point in the illness (provider confirmed non-response to treatment, progressive disease, or a symptomatic hospitalization within the last month),

    3. not be receiving specialty palliative care or hospice,

    4. read/speak English, and

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Melvin and Bren Simon Comprehensive Cancer Center Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Indiana University
    • American Cancer Society, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristin Levoy, Assistant Professor, Indiana University
    ClinicalTrials.gov Identifier:
    NCT05995860
    Other Study ID Numbers:
    • CTO-IUSCCC-0827
    First Posted:
    Aug 16, 2023
    Last Update Posted:
    Aug 16, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2023