Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 252
- 试验地点
- 11
- 主要终点
- Treatment completion (relative dose)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Pathology documentation from any hospital/clinic/medical center, and
- •FIGO Stage 1A with Grade 2, Grade 3, or Grade 4 of any histology type or
- •FIGO Stage 1A with non-endometrioid (carcinosarcoma, serous, clear cell, undifferentiated or mixed) histology
- •FIGO Stage 1B, 2, 3, or 4 of any grade or histology
- •Recurrent endometrial cancer of any stage or grade
- •Documented provider recommendation and patient plan to initiate adjuvant therapy with chemotherapy, radiation, and/or immunotherapy.
排除标准
- •Participants must not have any of the following exclusion criteria:
- •Newly diagnosis of FIGO Stage IA Grade 1 endometrioid adenocarcinoma
- •Previous history of other cancer diagnosis requiring chemotherapy, radiation therapy, or immunotherapy within the past 12 months;
- •Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
- •Contraindication to all non-surgical therapy available for endometrial cancer (i.e., chemotherapy, radiation, and immunotherapy contraindicated);
- •Enrollment into hospice prior to randomization
- •Unable to provide written informed consent in English;
- •Unable to be contacted for research surveys;
- •Recent hospitalization for psychiatric illness in the past 6 months
研究组 & 干预措施
Enhanced usual care
Written materials in an appealing package.
Facilitated group support
Weekly group gatherings.
干预措施: Facilitated group support (Behavioral)
1:1 Peer Support
Individual peer support calls.
干预措施: 1:1 Peer Support (Behavioral)
结局指标
主要结局
Treatment completion (relative dose)
时间窗: 6 months
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.
次要结局
- Patient-reported social isolation (SPS-24)(6 months)
研究者
Kemi Doll
Assistant Professor, School of Medicine
University of Washington