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Communication Intervention for Cancer Care (PRECursOr Trial)
N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At a transition point in the illness (provider confirmed non-response to treatment, progressive disease, or a symptomatic hospitalization within the last month)
Adult women with advanced, incurable gynecologic cancer (Stage III/IV disease at diagnosis combined with evidence of refractory/progressive disease after first-line treatment or recurrent disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once all surveys in the sample size are completed, 9 months anticipated
Awards & highlights
PRECursOr Trial Summary
This trial tests an idea to help doctors, nurses, patients and caregivers talk more openly during cancer care. Feedback is being sought to improve the idea.
Who is the study for?
This trial is for adult women with advanced, incurable gynecologic cancers who are at a critical point in their illness and have not responded well to initial treatments. They must speak English and not be receiving palliative care or hospice. Caregivers primarily involved in the patient's care can also participate if they meet similar language criteria.Check my eligibility
What is being tested?
The study tests an intervention aimed at improving communication between healthcare providers, patients with gynecologic cancer, and their caregivers during outpatient appointments. It seeks feedback on this approach before expanding it to more people.See study design
What are the potential side effects?
Since this trial focuses on communication strategies rather than medical treatments, there are no direct physical side effects associated with the interventions being tested.
PRECursOr Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My current treatment isn't working, my illness is getting worse, or I was hospitalized due to symptoms in the last month.
Select...
I am a woman with advanced gynecologic cancer that has not improved with treatment.
Select...
I am not in hospice or receiving end-of-life care.
PRECursOr Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ once all surveys in the sample size are completed, 9 months anticipated
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once all surveys in the sample size are completed, 9 months anticipated
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate overall participant satisfaction surveys.
Evaluate overall recruitment rates.
Explore group differences in communication behaviors during the audio-recorded encounters.
+2 morePRECursOr Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention group triadsExperimental Treatment1 Intervention
Group II: Control group triadsActive Control1 Intervention
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Who is running the clinical trial?
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,395 Total Patients Enrolled
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,101 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My current treatment isn't working, my illness is getting worse, or I was hospitalized due to symptoms in the last month.I am a woman with advanced gynecologic cancer that has not improved with treatment.I do not have speech or hearing difficulties that would prevent me from participating.You see a doctor who specializes in treating cancers of the female reproductive system at the IUSCCC gynecologic oncology clinic.I or my caregiver have cognitive difficulties.I am not in hospice or receiving end-of-life care.
Research Study Groups:
This trial has the following groups:- Group 1: Control group triads
- Group 2: Intervention group triads
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still capacity for new participants in this research endeavor?
"Unfortunately, the clinical trial in question is not actively recruiting at this time. Initially posted on June 14th 2023 and last updated on August 10th 2023, no participants are being sought; however, there are 620 other studies that require volunteers currently."
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