CompletedNot Applicable

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

United States47 participantsStarted 2023-06-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate overall recruitment rates.

Timeframe: Once all surveys in the sample size are completed, 9 months anticipated

Evaluate overall participant satisfaction surveys.

Timeframe: Once all surveys in the sample size are completed, 9 months anticipated

Explore group differences in communication behaviors during the audio-recorded encounters.

Timeframe: Once all encounters in the sample size are completed and transcribed, 9 months anticipated

Explore group differences in exit interview outcomes following the encounters.

Timeframe: Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated

Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes

Timeframe: Once all surveys in the sample size are completed, 9 months anticipated

Trial details

NCT IDNCT05995860

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-09

View on ClinicalTrials.gov More Vulvar Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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.

What they're measuring

Evaluate overall recruitment rates.

Timeframe: Once all surveys in the sample size are completed, 9 months anticipated

Evaluate overall participant satisfaction surveys.

Timeframe: Once all surveys in the sample size are completed, 9 months anticipated

Explore group differences in communication behaviors during the audio-recorded encounters.

Timeframe: Once all encounters in the sample size are completed and transcribed, 9 months anticipated

Explore group differences in exit interview outcomes following the encounters.

Timeframe: Once all encounters in the sample size are completed and transcribed and survey/interview completion, 9 months anticipated

Identify intervention approaches in exit interview that contributed to positive and/or negative outcomes

Timeframe: Once all surveys in the sample size are completed, 9 months anticipated

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria