Vulvar CancerPRECursOrNCT05995860
Study of a Rapid Triadic Communication Intention Elicitation Intervention to Improve Supportive Oncology Care Delivery
A study testing Intervention group triads in people with Vulvar Cancer and Ovarian Cancer, run by Indiana University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vulvar Cancer, Ovarian Cancer, Uterine Cancer
- What is being tested?
- Intervention group triads
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2023to 23 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
- patients and/or caregivers will be excluded if either one or both demonstrate:
- cognitive impairment, or
- speech/hearing difficulties precluding participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
About this study
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
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.
Read the 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.
- Conditions
- Vulvar Cancer, Ovarian Cancer, Uterine Cancer, Vaginal Cancer
- Being tested
- Intervention group triads
- Medical subject headings
- Vulvar Neoplasms, Ovarian Neoplasms, Uterine Neoplasms, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group triadsBehavioural
Also called PRECursOr
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group triads | No intervention | Not described |
| Intervention group triads | Experimental | Not described Receives: Behavioral: Intervention group triads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate overall recruitment rates.
PRECursOr will meet or exceed feasibility (overall recruitment, recruitment rate, measure completion, encounter duration).
Measured: Once all surveys in the sample size are completed, 9 months anticipated
Evaluate overall participant satisfaction surveys.
PRECursOr will meet or exceed acceptability (satisfaction, acceptability of approach) benchmarks per patient and caregiver questionnaire.
Measured: Once all surveys in the sample size are completed, 9 months anticipated
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.
Measured: Once all encounters in the sample size are completed and transcribed, 9 months anticipated
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.
Measured: 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
Identify intervention approaches that contributed to positive and/or negative outcomes to inform intervention refinement using qualitative research methods.
Measured: Once all surveys in the sample size are completed, 9 months anticipated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start14 Jun 2023
- Primary completion9 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Levoy, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995860
- Sponsor's protocol ID
- CTO-IUSCCC-0827
- Acronym
- PRECursOr
- Status last verified
- Jan 2025
- First submitted
- 10 Jul 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05995860
- Acronym / sponsor ID
- PRECursOr / CTO-IUSCCC-0827
- Conditions
- Vulvar Cancer, Ovarian Cancer, Uterine Cancer, Vaginal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group triads | No intervention | – |
| Intervention group triads | Experimental | Behavioral: Intervention group triads |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- patients will:
- caregivers will:
- providers will:
Key exclusion criteria (3 listed)
- cognitive impairment, or
- speech/hearing difficulties precluding participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group triadsAlso: PRECursOrThe 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. | Behavioural | Intervention group triads |
Primary outcome
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).
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group triads in people with Vulvar Cancer and Ovarian Cancer, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate overall recruitment rates. (time frame: Once all surveys in the sample size are completed, 9 months anticipated). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.