Study Summary
This trial will help to figure out the best way to provide social risk screening and referral services to cancer survivors in order to improve their quality of life.
Eligible Conditions
- Health Equity
- Prostate Cancer
- Inequality
- Breast Cancer
- Social Determinants of Health
Treatment Effectiveness
Effectiveness Progress
Study Objectives
7 Primary · 1 Secondary · Reporting Duration: 12 months
12 months
Acceptability of the CHW intervention
Appropriateness of the CHW intervention
Feasibility of the CHW intervention
Sustainability Assessment
3 months
Social risk factors
6 months
Health-related quality of life (QOL)
Patient Self-Efficacy
Social connectedness
Trial Safety
Trial Design
1 Treatment Group
Intervention participants
1 of 1
Experimental Treatment
1116 Total Participants · 1 Treatment Group
Primary Treatment: Community Health Worker support · No Placebo Group · N/A
Intervention participants
Behavioral
Experimental Group · 1 Intervention: Community Health Worker support · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Community Health Worker support
2008
N/A
~370
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
Medstar Health Research InstituteLead Sponsor
173 Previous Clinical Trials
132,820 Total Patients Enrolled
George Washington UniversityOTHER
209 Previous Clinical Trials
118,163 Total Patients Enrolled
Georgetown UniversityOTHER
320 Previous Clinical Trials
119,574 Total Patients Enrolled
Howard UniversityOTHER
34 Previous Clinical Trials
11,504 Total Patients Enrolled
Hannah Arem, PhDPrincipal InvestigatorMedstar Health Research Institute
2 Previous Clinical Trials
139 Total Patients Enrolled
Mandi Pratt-Chapman, PhDPrincipal InvestigatorGeorge Washington University
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Clarke, Tainya C., Sharon L. Christ, Hosanna Soler-Vila, David J. Lee, Kristopher L. Arheart, Guillermo Prado, Alberto Caban Martinez, and Lora E. Fleming. 2015. “Working with Cancer: Health and Employment Among Cancer Survivors”. Annals of Epidemiology. Elsevier BV. doi:10.1016/j.annepidem.2015.07.011.
- Hahn, Elizabeth A., on behalf of the PROMIS Cooperative Group, Robert F. DeVellis, Rita K. Bode, Sofia F. Garcia, Liana D. Castel, Susan V. Eisen, et al.. 2010. “Measuring Social Health in the Patient-reported Outcomes Measurement Information System (PROMIS): Item Bank Development and Testing”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1007/s11136-010-9654-0.
- Cella, David, William Riley, Arthur Stone, Nan Rothrock, Bryce Reeve, Susan Yount, Dagmar Amtmann, et al.. 2010. “The Patient-reported Outcomes Measurement Information System (PROMIS) Developed and Tested Its First Wave of Adult Self-reported Health Outcome Item Banks: 2005–2008”. Journal of Clinical Epidemiology. Elsevier BV. doi:10.1016/j.jclinepi.2010.04.011.
- Weaver, Kathryn E., Julia H. Rowland, Keith M. Bellizzi, and Noreen M. Aziz. 2010. “Forgoing Medical Care Because of Cost”. Cancer. Wiley. doi:10.1002/cncr.25209.
- Glasgow, Russell E., Bethany M. Kwan, and Daniel D. Matlock. 2018. “Realizing the Full Potential of Precision Health: The Need to Include Patient-reported Health Behavior, Mental Health, Social Determinants, and Patient Preferences Data”. Journal of Clinical and Translational Science. Cambridge University Press (CUP). doi:10.1017/cts.2018.31.
- Cella, David, Susan Yount, Nan Rothrock, Richard Gershon, Karon Cook, Bryce Reeve, Deborah Ader, James F. Fries, Bonnie Bruce, and Mattias Rose. 2007. “The Patient-reported Outcomes Measurement Information System (PROMIS)”. Medical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.mlr.0000258615.42478.55.
- Clarke TC, Christ SL, Soler-Vila H, Lee DJ, Arheart KL, Prado G, Caban-Martinez A, Fleming LE. Working with cancer: health and employment among cancer survivors. Ann Epidemiol. 2015 Nov;25(11):832-8. doi: 10.1016/j.annepidem.2015.07.011. Epub 2015 Aug 4. Erratum In: Ann Epidemiol. 2016 Jul;26(7):520.
- Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
- 2022. "Social Risk Factors and Discrimination in Cancer Survivorship". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05301114.
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Conditions
Cancer Related
Treatments