Social Support for Endometrial Cancer

(SISTER Trial)

Recruiting at 12 trial locations

Overseen By SISTER team

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Stage IA Grade 1, Other cancer, Hospice, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

252 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to support Black patients undergoing treatment for endometrial cancer, focusing on helping them complete their treatment and feel less isolated. Participants will be divided into three groups: one receiving individual peer support calls (1:1 Peer Support), another attending weekly group gatherings (Facilitated Group Support), and a third receiving helpful written materials. The trial aims to determine which type of social support benefits patients the most. It is well-suited for Black individuals diagnosed with high-risk endometrial cancer who are beginning treatment with chemotherapy, radiation, or immunotherapy. As an unphased trial, this study provides a unique opportunity to explore supportive care options tailored to their needs.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that social support treatments, such as 1:1 Peer Support and Facilitated Group Support, are generally safe for individuals undergoing cancer treatment. These methods aim to enhance emotional and social well-being, improving the overall treatment experience. Although specific safety data for these exact methods is lacking, similar approaches in other cancer studies have yielded positive results without serious safety concerns.

1:1 Peer Support involves individual calls, while Facilitated Group Support includes weekly group meetings. Both methods aim to reduce feelings of isolation during treatment. No evidence suggests that these support types cause harm or have negative effects. Instead, they help patients feel more connected and supported, potentially leading to better treatment completion and reduced social isolation.

These support methods have been used in other areas of cancer care without major safety issues, allowing participants to feel confident about their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these social support techniques for endometrial cancer because they offer a fresh approach to patient care. Unlike traditional treatments that focus on medical or surgical interventions, these methods aim to enhance emotional and psychological well-being. The 1:1 peer support involves personal calls with someone who has experienced the same journey, providing tailored emotional support. Facilitated group support, on the other hand, creates a community through weekly gatherings, fostering shared experiences and mutual encouragement. These innovative approaches recognize the importance of mental health in recovery and could significantly improve the overall quality of life for patients.

What evidence suggests that this trial's treatments could be effective for endometrial cancer?

This trial will compare different social support methods for Black patients with endometrial cancer. Participants may receive either one-on-one peer support, involving individual peer support calls, or facilitated group support, consisting of weekly group gatherings. Research has shown that both one-on-one peer support and group support sessions can help patients complete their treatment. Specifically, one study found that these types of social support increased the chances of patients finishing their cancer treatment. Feeling isolated can make it hard to stick with treatment, and these support methods aim to reduce that feeling by offering connection and encouragement. Regular contact with peers or group sessions can help patients feel less alone and more motivated to follow their treatment plan. Early evidence suggests these methods work well and are easy for patients to handle. ^{1 2 4 6 7}

Who Is on the Research Team?

Kemi M Doll, MD, MSCR

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 1:1 Peer Support
• Facilitated group support

Trial Overview 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.

How Is the Trial Designed?

Group I: 1:1 Peer Support Active Control 1 Intervention

Individual peer support calls.

Group II: Facilitated group support Active Control 1 Intervention

Weekly group gatherings.

Group III: Enhanced usual care Active Control 1 Intervention

Written materials in an appealing package.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A qualitative study involving 24 women with gynaecological cancer revealed that one-to-one telephone peer support can foster emotional bonds and provide empathy, guidance, and hope, helping recipients navigate their illness and recovery.

While many participants reported significant benefits from the peer support, about one-third experienced limited or no benefits, indicating that the effectiveness of such interventions may vary and highlighting the need for further research on factors influencing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone peer support for women with gynaecological cancer: recipients' perspectives. Pistrang, N., Jay, Z., Gessler, S., et al.[2016]

A 7-week peer support program for women with primary breast cancer showed positive outcomes, including reduced feelings of isolation and enhanced coping skills, as identified through focus group discussions with 8 participants.

The study highlighted the importance of tailoring peer support programs to address specific needs, such as support for hair loss and the inclusion of cancer survivors, to improve the overall effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitated peer support in breast cancer: a pre- and post-program evaluation of women's expectations and experiences of a facilitated peer support program. Power, S., Hegarty, J.[2019]

Peer support (PS) is an effective strategy in cancer care, with 76% of recent interventions focusing on improving clinical outcomes like screening and treatment adherence, and 72% aimed at reducing health disparities.

Most interventions were delivered via phone or in clinic settings, but only 2% addressed end-of-life care, indicating a significant opportunity to expand the use of PS in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support opportunities across the cancer care continuum: a systematic scoping review of recent peer-reviewed literature. Kowitt, SD., Ellis, KR., Carlisle, V., et al.[2020]

Women providing peer support to others with gynaecological cancer reported significant personal benefits, such as improved self-esteem and well-being, as well as gaining closure on their own cancer experiences.

While there were no adverse effects reported, supporters faced challenges like managing emotional involvement and supporting patients with poor prognoses, highlighting the need for proper training and support from healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone peer support for women with gynaecological cancer: benefits and challenges for supporters. Pistrang, N., Jay, Z., Gessler, S., et al.[2022]

In a study of 238 patients with endometrial or ovarian cancer, 79% reported high levels of perceived social support one year after treatment, indicating that social support is generally strong among these patients.

A distressed (type D) personality, characterized by negative emotions and social inhibition, was identified as a significant predictor of low perceived social support, suggesting that these individuals may require additional support during their cancer journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived social support in patients with endometrial or ovarian cancer: A secondary analysis from the ROGY care study. Scheepers, ERM., de Rooij, BH., Pijnenborg, JMA., et al.[2021]

A national peer support program for women at risk for or surviving breast cancer showed that 37% of participants engaged with the program, with higher utilization among mothers and those at increased genetic risk, indicating targeted outreach could enhance participation.

Participants reported high satisfaction with the peer support program, scoring an average of 42.8 out of 50, suggesting that well-trained lay coaches can effectively meet the diverse needs of breast cancer previvors and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators of peer coaching/support engagement and dissemination among women at risk for and surviving with breast cancer. Rehberg, K., Fleischmann, A., Silber, E., et al.[2021]

A systematic review of 18 studies, including 16 randomized controlled trials, evaluated the effects of peer-led supportive interventions for cancer patients, focusing on various outcomes like emotional health and quality of life.

The results indicate a need for more rigorous, theory-based evaluations to confirm the effectiveness of these peer-led interventions in cancer care, suggesting that while promising, further research is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis Lee, MK., Suh, SR.[2019]

A peer-to-peer support program was developed to provide emotional support and information to women undergoing treatment for gynecologic cancer and their families, highlighting the importance of psychosocial care in cancer treatment.

Participants in the program reported finding it to be a valuable source of support during their treatment, indicating its potential effectiveness in improving emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Woman to woman: a peer to peer support program for women with gynecologic cancer. Moulton, A., Balbierz, A., Eisenman, S., et al.[2013]

Citations

1. pcori.org pcori.org/research-results/2020/comparing-group-and-individual-based-social-support-interventions-completion-endometrial-cancer-treatment

Comparing Group and Individual-Based Social Support ... This study compares the clinical effectiveness of two different social support interventions versus enhanced usual care on the completion of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38348827/

Study Protocol for the Social Interventions for Support ... Aim: Social isolation in cancer patients is correlated with prognosis and is a potential mediator of treatment completion.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04930159

Social Interventions for Support During Treatment ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10945416/

Study Protocol for the Social Interventions for Support ... The primary objective of the SISTER study is to determine whether either of two virtual interventions (Facilitated Support Group; 1:1 Peer Support) improves ...

5. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(24)01151-X/fulltext

Engaging endometrial cancer survivors as peer supporters ... In order to meet this unmet need, the SISTER Study was designed to test the effect of peer support from EC survivors in a national, community-engaged, ...

6. researchinvolvement.biomedcentral.com researchinvolvement.biomedcentral.com/articles/10.1186/s40900-025-00760-w

Advancing equity in cancer research through principled ... Peer support during treatment can improve survival in other cancers, but this has not been tested among Black women with endometrial cancer. To ...

7. researchgate.net researchgate.net/publication/269713012_One-to-one_peer_support_in_cancer_care_a_review_of_scholarship_published_between_2007_and_2014_One-to-one_peer_support_in_cancer_care

One-to-one peer support in cancer care: a review of ... This paper provides process and outcome data from 77 people with cancer who completed an 8-week support group facilitated by licensed and ...