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Social Support for Endometrial Cancer (SISTER Trial)
N/A
Recruiting
Led By Kemi M Doll, MD, MS
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recurrent endometrial cancer of any stage or grade
FIGO Stage 1B, 2, 3, or 4 of any grade or histology
Must not have
Previous history of other cancer diagnosis requiring chemotherapy, radiation therapy, or immunotherapy within the past 12 months
Newly diagnosis of FIGO Stage IA Grade 1 endometrioid adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether social support can help Black patients with endometrial cancer finish their treatment.
Who is the study for?
The SISTER study is for Black adults over 18 with high-risk endometrial cancer, including various stages and grades, or recurrent endometrial cancer. Participants must be starting adjuvant therapy but can't join if they have contraindications to such therapies, other recent cancers treated within a year, the least aggressive type of this cancer (Stage IA Grade 1), are in custody/hospice, unable to consent or be contacted.
What is being tested?
This trial examines social support's effect on treatment completion and reducing isolation during endometrial cancer care. It randomly assigns patients to group support sessions, one-on-one peer support, or enhanced usual care without additional social interventions.
What are the potential side effects?
Since the interventions involve social support rather than medical treatments, there may not be direct physical side effects. However, participants might experience emotional discomfort when discussing their condition in a group or with peers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cancer has come back.
Select...
My cancer is at a stage between 1B and 4, regardless of its type.
Select...
My endometrial cancer is classified as high-risk based on its stage and grade.
Select...
My cancer is early stage with a high grade or is not endometrioid type.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had cancer treatments other than for my current condition in the last year.
Select...
I have been newly diagnosed with a specific early-stage uterine cancer.
Select...
I cannot undergo any non-surgical treatments for endometrial cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment completion (relative dose)
Secondary study objectives
Patient-reported social isolation (SPS-24)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: 1:1 Peer SupportActive Control1 Intervention
Individual peer support calls.
Group II: Facilitated group supportActive Control1 Intervention
Weekly group gatherings.
Group III: Enhanced usual careActive Control1 Intervention
Written materials in an appealing package.
Find a Location
Who is running the clinical trial?
Patient-Centered Outcomes Research InstituteOTHER
580 Previous Clinical Trials
27,105,007 Total Patients Enrolled
University of WashingtonLead Sponsor
1,831 Previous Clinical Trials
1,907,317 Total Patients Enrolled
Kemi M Doll, MD, MSPrincipal InvestigatorUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My endometrial cancer has come back.My cancer is at a stage between 1B and 4, regardless of its type.I have not had cancer treatments other than for my current condition in the last year.My endometrial cancer is classified as high-risk based on its stage and grade.I am 18 years old or older.My cancer is early stage with a high grade or is not endometrioid type.My doctor and I plan to start additional treatment after my main cancer treatment.I have been newly diagnosed with a specific early-stage uterine cancer.I cannot undergo any non-surgical treatments for endometrial cancer.
Research Study Groups:
This trial has the following groups:- Group 1: 1:1 Peer Support
- Group 2: Facilitated group support
- Group 3: Enhanced usual care
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.