NCT06855654Toboroz
Promoting Resilience in Women With Breast Cancer (PRISM -MBC)
Evaluating Psychological and Survival Outcomes of the Promoting Resilience in Stress Management for Metastatic Breast Cancer (PRISM-MBC) Intervention
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 15.
Rövid összefoglaló (regiszter, angolul)
This pilot interventional study evaluates the change from baseline to post-intervention in resilience and other patient-reported outcomes for individuals with a recent diagnosis of metastatic breast cancer (MBC) participating in the Promoting Resilience in Women with Breast Cancer (PRISM) intervention, overall and stratified by race, and to evaluate the feasibility and acceptability of the PRISM intervention in the MBC population. Black women with MBC have shorter survival from the time of metastatic diagnosis to death, compared to White women with clinically similar disease, and may have more rapid declines in quality of life over time. Adverse social determinants of health may play a role in these outcome disparities, due to both social barriers in accessing care, and through direct stress-mediated biological effects on the host and tumor microenvironment. Interventions to reduce stress and optimize resilience during treatment of MBC may improve quality of life and even improve disease outcomes; however, feasibility of face-to-face intervention during intensive medical treatment is limited. Thus, this study aims to demonstrate the feasibility of a remotely delivered resilience intervention, PRISM, already proven effective in other cancer settings, for MBC patients, and to gather preliminary efficacy data for a future randomized trial.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 120 (tervezett)
- Első benyújtás
- 2025. febr. 26.
- Kezdés
- 2025. jan. 1.
- Elsődleges befejezés
- 2027. dec. 1.
- Fő szponzor
- UNC Lineberger Comprehensive Cancer Center
- Betegségek
- Áttétes emlőrák
- NCT-szám
- NCT06855654
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 120
- 2025. jan. 1. és az elsődleges befejezés (2027. dec. 1.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Patient has permanently discontinued cancer-directed therapy or does not intend to receive any cancer-directed therapy, is receiving home or residential hospice care, is hospitalized, or is described as likely to die within 90 days or actively dying in last provider documentation, at the time of enrollment.
Egyéb
- Individuals meeting any of the following exclusion criteria will be excluded from study participation.
- Patient unwilling or unable to complete surveys via one of the following methods: (a) paper survey completed in clinic or mailed directly to patient's home address, including a pre-addressed, pre-stamped return envelope in the mailed survey packet, or (b) electronic survey links sent via emails or text link on a mobile device, tablet, laptop, or desktop computer.
- Patient unwilling or unable to provide verbal or signed consent to participate.
- Participant cannot read English.
Kiket keres a vizsgálat
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Participants are willing and able to comply with study procedures based on the judgement of the investigator.
- Male and female patients of age >18 years.
- Pathologic diagnosis of metastatic breast cancer within 182 days prior to enrollment date.
- Able to answer surveys and participate in counseling sessions in English (the patient's first language is not required to be English).
- Indicate intent to receive ongoing cancer care at the enrolling institution.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The University of Alabama | Birmingham | Egyesült Államok | Toboroz |
| University of North Carolina | Chapel Hill | Egyesült Államok | Toboroz |
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