Social Support for Endometrial Cancer
(SISTER Trial)
Recruiting in Palo Alto (17 mi)
+12 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Disqualifiers: Stage IA Grade 1, Other cancer, Hospice, Psychiatric illness, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Social Support Intervention for Endometrial Cancer?
Research shows that peer support, including one-to-one and group support, is valued by cancer patients and can help reduce social isolation and improve coping skills. Studies on women with breast cancer have found that peer support provides emotional and informational benefits, suggesting it could be similarly beneficial for women with endometrial cancer.
12345Is social support safe for people with cancer?
Research on peer support for women with gynecological and breast cancer suggests it is generally safe, providing emotional and informational benefits without reported safety concerns.
13567How does the social support treatment for endometrial cancer differ from other treatments?
This treatment is unique because it focuses on providing emotional and informational support through one-to-one peer interactions, rather than traditional medical interventions. It aims to reduce psychological distress and improve quality of life by connecting patients with others who have experienced similar challenges.
13678Eligibility Criteria
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.Inclusion Criteria
My endometrial cancer has come back.
My cancer is at a stage between 1B and 4, regardless of its type.
Self-identify as Black/African American
+4 more
Exclusion Criteria
Incarcerated in a detention facility or in police custody at baseline/screening
I have not had cancer treatments other than for my current condition in the last year.
Unable to provide written informed consent in English
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive chemotherapy, radiation, or immunotherapy along with social support interventions
6 months
Weekly group gatherings or individual peer support calls
Follow-up
Participants are monitored for treatment completion and social isolation
4 weeks
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WashintonSeattle, WA
University Hospitals Cleveland Medical CenterCleveland, OH
Liz SageSeattle, WA
University of North CarolinaChapel Hill, NC
More Trial Locations
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
References
Telephone peer support for women with gynaecological cancer: recipients' perspectives. [2016]Peer support is much valued by cancer patients. Previous research has focused on support groups, typically for women with breast cancer; little has addressed one-to-one support. This qualitative study examined a telephone-delivered one-to-one peer support intervention for women with gynaecological cancer, focusing on recipients' experiences of process and outcome.
Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis [2019]To evaluate the effects of peer-led supportive interventions for patients with cancer. .
Peer support opportunities across the cancer care continuum: a systematic scoping review of recent peer-reviewed literature. [2020]Evidence suggests peer support (PS) is as an effective strategy for enhancing prevention and control of chronic and infectious diseases, including cancer. This systematic scoping review examines the range and variety of interventions on the use of PS across the cancer care continuum.
Facilitators of peer coaching/support engagement and dissemination among women at risk for and surviving with breast cancer. [2021]One-on-one peer coaching/support programs hold promise in promoting healthy outcomes among women at risk for and surviving with breast cancer, with the potential to bridge gaps in "whole person care." Although popularly cited for their benefits, emerging evidence is mixed and suggests that peer support program impacts may be attenuated by individual- and community-specific factors. We evaluated a national not-for-profit breast cancer organization's peer support program outcomes (2015-2018) serving women from predominantly Jewish backgrounds to examine program engagement, facilitation, and satisfaction. Of the N = 392 women sampled, 37% utilized the peer support program: the majority were referred by a family member/friend (40%) or had connected with the program online (34%). Logistic regression modeling revealed that mothers (odds ratio [OR] = 1.82; 95% confidence interval [CI] = 1.04 to 3.19), women at increased genetic risk for breast cancer (OR = 2.07; 95% CI = 1.08 to 3.94), and those who connected with the organization through a family member/friend (OR = 1.97; 95% CI = 1.23 to 3.15) were significantly more likely to utilize peer support (all p's
Facilitated peer support in breast cancer: a pre- and post-program evaluation of women's expectations and experiences of a facilitated peer support program. [2019]Peer support programs are associated with the provision of emotional, informational, and appraisal support. The benefits of peer support for women with breast cancer include reduced social isolation, enhanced coping, and access to information.
Woman to woman: a peer to peer support program for women with gynecologic cancer. [2013]Gynecologic cancer has significant emotional and psychosocial implications for patients and their families. This article describes the origin and implementation of a peer to peer support program providing emotional support and information to women in treatment for gynecologic cancer and their families, in collaboration with medical and social work staff in a large, urban medical center. A formative evaluation of the program is included which suggests program participants view the program as a helpful source of support throughout treatment.
Telephone peer support for women with gynaecological cancer: benefits and challenges for supporters. [2022]Despite the prevalence of one-to-one peer support programmes for people with cancer, little research has examined its impact on the supporters themselves. This qualitative study examined a telephone-delivered one-to-one peer support intervention for women with gynaecological cancer, focussing on supporters' subjective experiences of benefits or costs to themselves and challenges arising in the support process.
Perceived social support in patients with endometrial or ovarian cancer: A secondary analysis from the ROGY care study. [2021]Social support may reduce the amount of psychological distress and increase quality of life. This study assessed whether socio-demographic, personality, and clinical characteristics predict the level of perceived social support in patients with endometrial or ovarian cancer.