Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RG1121627 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| NCI-2021-12773 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
The SISTER study is a randomized trial, looking at various modalities of social support for Black patients undergoing treatment for endometrial cancer. There are three study arms: group support, 1:1 peer support, and enhanced usual care. The primary outcome is treatment completion, and the secondary outcome is social isolation.
SISTER is a prospective, open randomized controlled trial of U.S. Black/African-American people with high-risk endometrial cancer requiring treatment with chemotherapy, radiation, or immunotherapy. We will compare social support interventions of enhanced usual care, weekly group-based support, and 1:1 peer support to determine the most effective option to improve treatment completion and decrease social isolation.
The SISTER study comparators are based on multiple systematic reviews of peer support literature, input from the multi-stakeholder Steering Group of the Endometrial Cancer Action Network for African Americans (ECANA), two focus groups of Black women with EC, and cancer center leadership at selected enrollment sites. The core function of each comparator is to decrease social isolation for women on active treatment. Of the peer support intervention options available, the SISTER study includes the two that have the most data collected among Black women with cancer, have been most efficacious with regard to social isolation9 and treatment completion, and were enthusiastically supported by ECANA patient partners and focus group data.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced usual care | No Intervention | Written materials in an appealing package. | |
| Facilitated group support | Active Comparator | Weekly group gatherings. |
|
| 1:1 Peer Support | Active Comparator | Individual peer support calls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facilitated group support | Behavioral | Weekly group gatherings where content will alternate between group conversation and focused topics (e.g., treatment side-effects, mental health, family dynamics, nutrition, financial hardship) with facilitated discussion by a trained professional in nutrition, psychotherapy, cognitive behavioral therapy, or medicine. Each group will cycle through the same order of topics. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment completion (relative dose) | Relative dose is the ratio of actual-to-expected total dose of treatment received. The calculation of expected total dose will be made from the baseline treatment recommendation data collected at enrollment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported social isolation (SPS-24) | The Social Provisions Scale (SPS) is one of the most frequently used scales on social support, and is validated to measure the components of social support that directly impact health outcomes: attachment, social integration, reassurance of worth, reliable alliance, guidance, and opportunity for nurturance. | 6 months |
Not provided
Inclusion Criteria:
Adult 18 years of age or older; and
Self-identify as Black/African American
Presenting with high-risk EC established by anatomic pathology as tumor stage and grade classification by the following:
Documented provider recommendation and patient plan to initiate adjuvant therapy with chemotherapy, radiation, and/or immunotherapy.
Exclusion Criteria:
Participants must not have any of the following exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kemi M Doll, MD, MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38348827 | Derived | Oluloro A, Comstock B, Monsell SE, Gross M, Wolff EM, Sage L, Alson J, Lavallee DC, Hempstead B, Moore A, Katz R, Doll KM. Study Protocol for the Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (SISTER) study: a community engaged national randomized trial. J Comp Eff Res. 2024 Mar;13(3):e230159. doi: 10.57264/cer-2023-0159. Epub 2024 Feb 13. |
Not provided
Not provided
Only de-identified data will be shared with other researchers. Researchers will be required to receive approval from the SISTER Advocate Advisory Board to receive data.
The time frame is to be determined, in partnership with the SISTER Executive Committee and Advocate Advisory Board
The access criteria is to be determined, in partnership with the SISTER Executive Committee and Advocate Advisory Board
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Part 1 (all sites) | Aug 3, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1:1 Peer Support | Behavioral | 1:1 peer support via telephone or video either during or near a treatment visit. Call content will be focused on social support and driven by the needs of the participant. |
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Louisiana State University - New Orleans | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21218 | United States |
| MedStar Health Research Institute | Columbia | Maryland | 21044 | United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98105 | United States |
| Jan 7, 2026 |
| ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Part 2 (site specific) | Sep 1, 2021 | Jan 7, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided