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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

SISTER Trial 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.Check my eligibility

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.See study design

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.

SISTER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

SISTER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment completion (relative dose)

Secondary outcome measures

Patient-reported social isolation (SPS-24)

SISTER 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,997,206 Total Patients Enrolled

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,508 Total Patients Enrolled

Kemi M Doll, MD, MSPrincipal InvestigatorUniversity of Washington

Media Library

1:1 Peer Support Clinical Trial Eligibility Overview. Trial Name: NCT04930159 — N/A

Endometrial Cancer Research Study Groups: 1:1 Peer Support, Facilitated group support, Enhanced usual care

Endometrial Cancer Clinical Trial 2023: 1:1 Peer Support Highlights & Side Effects. Trial Name: NCT04930159 — N/A

1:1 Peer Support 2023 Treatment Timeline for Medical Study. Trial Name: NCT04930159 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for this trial?

"As per the data posted on clinicaltrials.gov, this trial is still recruiting participants. It was first announced back in September 2021 and had its most recent update detailed at the end of October 2022."

Answered by AI

Has this clinical trial been extended to any Canadian facilities yet?

"Participants are being recruited at Johns Hopkins University (Baltimore, Maryland), Fred Hutch/University of Washington Cancer Consortium in Seattle, Washington and Weill Cornell Medicine (New york City) as well as an additional 9 clinical trial sites."

Answered by AI

What is the aggregate amount of participants in this clinical trial?

"Affirmative. Clinicaltrials.gov supports the ongoing recruitment of participants for this medical study, which was initially posted on September 1st 2021 and last revised October 26th 2022. 252 individuals are being recruited from 9 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence

Kemi Doll 2021. "Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04930159.