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

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. ^{1 2 3 4 5}

Is 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. ^{1 3 5 6 7}

How 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. ^{1 3 6 7 8}

Research Team

Kemi M Doll, MD, MSCR

Principal Investigator

University of Washington

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Telephone peer support for women with gynaecological cancer: recipients' perspectives. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Peer-Led Interventions for Patients With Cancer: A Meta-Analysis [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Peer support opportunities across the cancer care continuum: a systematic scoping review of recent peer-reviewed literature. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Facilitators of peer coaching/support engagement and dissemination among women at risk for and surviving with breast cancer. [2021]

5. United States 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Woman to woman: a peer to peer support program for women with gynecologic cancer. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Telephone peer support for women with gynaecological cancer: benefits and challenges for supporters. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Perceived social support in patients with endometrial or ovarian cancer: A secondary analysis from the ROGY care study. [2021]