Study Protocol for the Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (SISTER) study: a community engaged national randomized trial
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: Social isolation in cancer patients is correlated with prognosis and is a potential mediator of treatment completion. Black women with endometrial cancer (EC) are at increased risk for social isolation when compared with White patients. We developed the Social Interventions for Support during Treatment for Endometrial Cancer and Recurrence (SISTER) study to compare and evaluate interventions to address social isolation among Black women with high-risk EC in USA. The primary objective of the SISTER study is to determine whether virtual support interventions improve treatment completion compared with Enhanced Usual Care. Secondary objectives include comparing effectiveness virtual evidence-based interventions and evaluating barriers and facilitators to social support delivery. Patients & methods: This is a multi-site prospective, open-label, community-engaged randomized controlled trial, consisting of three intervention arms: enhanced usual care, facilitated support group and one-to-one peer support. Primary outcome will be measured using relative dose. Qualitative semi-structured interviews will be conducted with a subset of participants to contextualize the relative degree or lack thereof of social isolation, over time. Data analysis: Primary analysis will be based on an intent-to-treat analysis. Multivariable analysis will be performed to determine the effect of the intervention on the primary and secondary outcomes of interest, relative dose and social isolation score. Semi-structured interviews will be qualitatively analyzed using inductive and deductive approaches of content analysis. Discussion/conclusion: Endometrial cancer mortality disproportionately affects Black women, and social isolation contributes to this disparity. The SISTER study aims to identify whether and to what extent differing social support vehicles improve key outcomes for Black women in the United States with high-risk EC.
Clinical Trial Registration: NCT04930159 (ClinicalTrials.gov)
Formats available
You can view the full content in the following formats:
References
1.
American Cancer Society. Cancer Facts & Figures 2020. Atlanta, GA, USA (2020).
2.
Islami F, Ward EM, Sung H et al. Annual Report to the Nation on the Status of Cancer, Part 1: National Cancer Statistics. J. Natl Cancer Inst. 113(12), 1648–1669 (2021).
3.
Cancer of the Endometrium. Cancer Stat Facts. https://seer.cancer.gov/statfacts/html/corp.html
4.
Abu-Rustum N, Yashar C, Arend R et al. Uterine Neoplasms, Version 1.2023, NCCN Clinical Practice Guidelines in Oncology. J. Natl Compr. Canc. Netw. 21(2), 181–209 (2023).
5.
SGO Clinical Practice Endometrial Cancer Working Group; Burke WM, Orr J, Leitao M et al; Society of Gynecologic Oncology Clinical Practice Committee. Endometrial cancer: a review and current management strategies: part I. Gynecol. Oncol. 134(2), 385–392 (2014).
6.
SGO Clinical Practice Endometrial Cancer Working Group; Burke WM, Orr J, Leitao M et al; Society of Gynecologic Oncology Clinical Practice Committee. Endometrial cancer: a review and current management strategies: part II. Gynecol. Oncol. 134(2), 393–402 (2014).
7.
Clarke MA, Devesa SS, Harvey SV, Wentzensen N. Hysterectomy-corrected uterine corpus cancer incidence trends and differences in relative survival reveal racial disparities and rising rates of nonendometrioid cancers. J. Clin. Oncol. 37(22), 1895–1908 (2019).
8.
Collins Y, Holcomb K, Chapman-Davis E, Khabele D, Farley JH. Gynecologic cancer disparities: a report from the Health Disparities Taskforce of the Society of Gynecologic Oncology. Gynecol. Oncol. 133(2), 353–361 (2014).
9.
Chatterjee S, Gupta D, Caputo TA, Holcomb K. Disparities in gynecological malignancies. Front. Oncol. 6, 36 (2016).
10.
Alcaraz KI, Eddens KS, Blase JL et al. Social Isolation and Mortality in US Black and White Men and Women. Am. J. Epidemiol. 188(1), 102–109 (2019).
11.
Pantell M, Rehkopf D, Jutte D, Syme SL, Balmes J, Adler N. Social isolation: a predictor of mortality comparable to traditional clinical risk factors. Am. J. Public Health 103(11), 2056–2062 (2013).
12.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Distress Management. Version 2.2021. https://www.nccn.org/professionals/physician_gls/pdf/distress.pdf (2021).
13.
Whitehead NE, Hearn LE. Psychosocial interventions addressing the needs of Black women diagnosed with breast cancer: a review of the current landscape. Psychooncology 24(5), 497–507 (2015).
14.
Blackman DJ, Masi CM. Racial and ethnic disparities in breast cancer mortality: are we doing enough to address the root causes? J. Clin. Oncol. 24(14), 2170–2178 (2006).
15.
Duma N, Vera Aguilera J, Paludo J et al. Representation of minorities and women in oncology clinical trials: review of the past 14 years. J. Oncol. Pract. 14(1), e1–e10 (2018).
16.
Cykert S, Dilworth-Anderson P, Monroe MH et al. Factors associated with decisions to undergo surgery among patients with newly diagnosed early-stage lung cancer. JAMA 303(23), 2368–2376 (2010).
17.
Langford AT, Resnicow K, Dimond EP et al. Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute's Community Cancer Centers Program. Cancer 120(6), 877–884 (2014).
18.
Duma N, Vera Aguilera J, Paludo J et al. Representation of minorities and women in oncology clinical trials: review of the past 14 years. J. Oncol. Pract. 14(1), e1–e10 (2018).
19.
NIMHD. Diversity and Inclusion in Clinical Trials. https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html
20.
Kim ES, Bruinooge SS, Roberts S et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement. J. Clin. Oncol. 35(33), 3737–3744 (2017).
21.
US Food and Drug Administration. Enhancing the Diversity of Clinical Trial Populations – Eigibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. https://www.fda.gov/media/127712/download
22.
Kroenke CH. A conceptual model of social networks and mechanisms of cancer mortality, and potential strategies to improve survival. Transl. Behav. Med. 8(4), 629–642 (2018).
23.
Endometrial Cancer Action Network for African-Americans. https://ecanawomen.org/
24.
Farley JH, Tian C, Rose GS et al. Chemotherapy intensity and toxicity among black and white women with advanced and recurrent endometrial cancer: a Gynecologic Oncology Group Study. Cancer 116(2), 355–361 (2010).
25.
DeWalt DA, Rothrock N, Yount S, Stone AA. PROMIS Cooperative Group. Evaluation of item candidates: the PROMIS qualitative item review. Med. Care 45(1 Suppl. 5), S12–S21 (2007).
26.
SI PROMIS Item Bank v2.0, Short Form 4a. https://www.healthmeasures.net/index.php?option=com_content&view=category&layout=blog&id=147&Itemid=806
27.
Meyer A, Coroiu A, Korner A. One-to-one peer support in cancer care: a review of scholarship published between 2007 and 2014. Eur. J. Cancer Care (Engl.) 24(3), 299–312 (2015).
28.
Cella D, Riley W, Stone A et al; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J. Clin. Epidemiol. 63(11), 1179–1194 (2010).
29.
Wilford J, Osann K, Hsieh S, Monk B, Nelson E, Wenzel L. Validation of PROMIS emotional distress short form scales for cervical cancer. Gynecol. Oncol. 151(1), 111–116 (2018).
30.
Teresi JA, Ocepek-Welikson K, Kleinman M, Ramirez M, Kim G. Measurement equivalence of the Patient Reported Outcomes Measurement Information System® (PROMIS®) anxiety short forms in ethnically diverse groups. Psychol. Test Assess. Model. 58(1), 183–219 (2016).
31.
Northwestern University. HealthMeasures. List of Adult Measures. https://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis/list-of-adult-measures (2020).
32.
Centers for Disease Control and Prevention. Racism. https://www.cdc.gov/dhdsp/health_equity/racism.htm (2023).
33.
de Souza JA, Yap BJ, Wroblewski K et al. Measuring financial toxicity as a clinically relevant patient-reported outcome: the validation of the COmprehensive Score for financial Toxicity (COST). Cancer 123(3), 476–484 (2017).
34.
Cella DF, Tulsky DS, Gray G et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J. Clin. Oncol. 11(3), 570–579 (1993).
35.
Matei D, Filiaci V, Randall ME et al. Adjuvant chemotherapy plus radiation for locally advanced endometrial cancer. N. Engl. J. Med. 380(24), 2317–2326 (2019).
36.
FACIT. Questionnaires. https://www.facit.org/FACITOrg/Questionnaires (2020).
37.
Marshall GN, Hays RD. The Patient Satisfaction Questionnaire Short-Form (PSQ-18). RAND (1994). https://www.rand.org/content/dam/rand/pubs/papers/2006/P7865.pdf
38.
Simien EM. Race, Gender, and Linked Fate. Black Studies 35(5), 529–550 (2005).
39.
Flannery IM, Yoo GJ, Levine EG. Keeping us all whole: acknowledging the agency of African American breast cancer survivors and their systems of social support. Support. Care Cancer 27(7), 2625–2632 (2019).
40.
National Comprehensive Cancer Network. Finding Support Systems for People with Cancer. https://www.nccn.org/patients/resources/life_with_cancer/managing_symptoms/support.aspx (2020).
41.
Heiney SP, Millon Underwood S, Tavakoli A, Arp Adams S, Wells LM, Bryant LH. Randomized trial of therapeutic group by teleconference: african American women with breast cancer. Cancer 118(15), 3822–3832 (2012).
42.
van Spijker BA, Batterham PJ, Calear AL et al. The suicidal ideation attributes scale (SIDAS): community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat. Behav. 44(4), 408–419 (2014).
43.
R statistical software. The R Project for Statistical Computing. https://www.r-project.org/
44.
Gamble CR, Sage L, Nguyen A et al. Social support and resilience in Black women affected by endometrial cancer. Am. J. Obstet. Gynecol. 226(1), 145–149 (2022).
45.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med. Care 50(3), 217–226 (2012).
46.
Kirk CM, Johnson-Hakim S, Anglin A, Connelly C. Putting the community back into community health needs assessments: maximizing partnerships via community-based participatory research. Prog. Community Health Partnersh. 11(2), 167–173 (2017).
47.
Ioannidis JP, Greenland S, Hlatky MA et al. Increasing value and reducing waste in research design, conduct, and analysis. Lancet 383(9912), 166–175 (2014).
Information & Authors
Information
Published In
Copyright
© 2024 The Authors. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License
History
Received: 19 October 2023
Accepted: 17 January 2024
Published online: 13 February 2024
Keywords:
Topics
Authors
Metrics & Citations
Metrics
Article Usage
Article usage data only available from February 2023. Historical article usage data, showing the number of article downloads, is available upon request.
Citations
How to Cite
Study Protocol for the Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (SISTER) study: a community engaged national randomized trial. (2024) Journal of Comparative Effectiveness Research. DOI: 10.57264/cer-2023-0159
Export citation
Select the citation format you wish to export for this article or chapter.
Citing Literature
- Dena Salehipour, Beza Tadess, Adrienne Moore, Tiffany Jones, Ann Oluloro, Wenora Johnson, Tiffany Drummond, Kimberly Richardson, Sheila Siders, Delanda Bartens Perez, Julianna G. Alson, Kemi M. Doll, Enhancing engagement in biobanking research among Black women with endometrial cancer, Gynecologic Oncology, 10.1016/j.ygyno.2026.03.001, 208, (32-40), (2026).
- Monique Reed, Michael E. Schoeny, Tristan Banks, Barbara Swanson, Christy Tangney, Wrenetha A. Julion, Application of Public Health Critical Race Praxis to Refine Black Girls Move: An Obesity Prevention Intervention for Black Adolescent Daughter/Mother Dyads, Western Journal of Nursing Research, 10.1177/01939459261431023, 48, 7, (783-794), (2026).
- Regina Gironés Sarrió, Javier David Benítez Fuentes, Victoria García Samblás, Mónica Guillot Morales, Patricia Palacios Ozores, Ana Ruiz-Casado, Javier Torres-Jiménez, María Vieito Villar, Impact of social determinants on the development, diagnosis, and treatment of cancer: recommended public health interventions, Clinical and Translational Oncology, 10.1007/s12094-025-04129-z, (2025).
- Julianna G. Alson, Kemi M. Doll, Bridgette H. Hempstead, Lisa Barr, Danielle C. Lavallee, Liz Sage, Adrienne Moore, Scott D. Ramsey, Erika M. Wolff, Bryan A. Comstock, Sarah E. Monsell, Ronit Katz, Charlotte R. Gamble, Anna L. Beavis, Monika Watat, Alvine Ngouonga, Ann Oluloro, Patrice Williams, Leah Franklin, Beza Tadess, Sarah Temkin, Anissa Foster, Juanita Jamison, Wenora Johnson, Bianca Body, Nefa-Tari Moore, Carol L. Brown, Joia Crear-Perry, Wui-Jin Koh, Charles R. Thomas, Michael J. Birrer, Elizabeth M. Swisher, Monica R. McLemore, Jacqueline Mbayo, Kimberly Vann, Margie Wilson, Martha Jean Williams, Micheal Goodwin, Shawn Smith, Sheila Johnson, Stephenie Black-Grant, Navya Nair, Abdulrahman Sinno, Rebeca Arend, Heather R. Williams, Nita Lee, Victoria Bae-Jump, Eloise Chapman-Davis, Onyi D. Balogun, Jay Mendoza, Soledad Jorge, Advancing equity in cancer research through principled partnership: stakeholder engagement practices in The Social Interventions for Support during Treatment for Endometrial cancer and Recurrence (SISTER) Study, Research Involvement and Engagement, 10.1186/s40900-025-00760-w, 11, 1, (2025).
- A. Chitrakar, N. Darko, E.L. Moss, Seeing red..? Co-design of a culturally tailored uterine cancer awareness intervention for Asian and Black ethnic minority groups, Gynecologic Oncology Reports, 10.1016/j.gore.2025.101690, 58, (101690), (2025).
- Elizabeth McGladrigan, Elizabeth Wrench, Ewan Dean, Aneurin O’Neil, Lisa Ashmore, Christopher Gaffney, Exploring prehabilitation interventions for patients with gynaecological cancer undergoing radiotherapy: A scoping review, PLOS ONE, 10.1371/journal.pone.0319518, 20, 3, (e0319518), (2025).
- Vincenzo Dario Mandato, Marcella Paterlini, Federica Torricelli, Elisa Rabitti, Valentina Mastrofilippo, Lorenzo Aguzzoli, Perceived social support and quality of life in endometrial cancer patients: a longitudinal study, Frontiers in Oncology, 10.3389/fonc.2024.1447644, 14, (2024).