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Communication Intervention for Cancer Care (PRECursOr Trial)
N/A
Recruiting
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)
Must not have
Patients and/or caregivers with speech/hearing difficulties precluding participation
Patients and/or caregivers with cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once all surveys in the sample size are completed, 9 months anticipated
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have speech or hearing difficulties that would prevent me from participating.
Select...
I or my caregiver have cognitive difficulties.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate overall participant satisfaction surveys.
Evaluate overall recruitment rates.
Explore group differences in communication behaviors during the audio-recorded encounters.
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention group triadsExperimental Treatment1 Intervention
Group II: Control group triadsActive Control1 Intervention
Find a Location
Who is running the clinical trial?
American Cancer Society, Inc.OTHER
231 Previous Clinical Trials
109,651 Total Patients Enrolled
Indiana UniversityLead Sponsor
1,039 Previous Clinical Trials
1,218,998 Total Patients Enrolled
Media Library
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.
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