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Completed

NCT Number: NCT05995860

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

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.

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Key information

Conditions

Vulvar Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Joe and Shelly Schwarz Cancer Center, Carmel, Indiana, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients will:
  • be adult women with an incurable gynecologic cancer (i.e., evidence of refractory/progressive disease after first-line treatment or recurrent disease),
  • 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.

Treatment and study plan

Intervention group triads

Behavioral

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

Primary outcomes

  1. Evaluate overall recruitment rates.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study 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

Acronym: PRECursOr

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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