Peer Navigator uddannelse i forbedring af overlevelsespleje hos afroamerikanske brystkræftoverlevere
Sister Survivor: Forbedring af overlevelsesplejen for afroamerikanske kvinder med brystkræft
This randomized clinical trial studies peer navigator education in improving survivorship care in African American breast cancer survivors. An educational intervention involving peer groups may help to improve the well-being and quality of life (QOL) in breast cancer survivors
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. To evaluate the ability of peer navigation (PN) to improve understanding of survivorship care planning (SCP) at 6 months.
II. To promote adherence to the SCP schedule of follow-up examinations at 12 months.
SECONDARY OBJECTIVES:
I. To evaluate the effect of PN on change from baseline in medical efficacy, preparedness for life as new survivor, and physical and health related QOL at 6 months.
OUTLINE: PNs are trained on medical issues and resources, and SCP. Participants are then randomized to 1 of 2 treatment arms.
ARM I: Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and American Cancer Society (ACS) materials.
ARM II: Participants receive ACS materials.
After completion of study treatment, patients are followed up at 6 and 12 months.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010
- City of Hope Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- TRIAL SUBJECTS:
- Patient age 18 years or older who self-identifies as African-American
- In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer
- Receiving health care primarily through an health maintenance organization (HMO)
- Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different
- Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded
- PEER NAVIGATORS:
- At least 25 years of age who self-identifies as African-American
- Previously participated in any type of research study
- Has at least high school education
- Has been diagnosed with breast cancer, currently in remission or eradicated
- Belongs to a breast cancer support group
- Has a valid driver's license
- Owns an operational vehicle
- Has access to a personal computer with internet access
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm I (PN and ACS material)
Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials. |
Ancillary studies
Andre navne:
Ancillary studies Receive ACS material
Andre navne:
Undergo PN session
Andre navne:
Ancillary studies |
|
Aktiv komparator: Arm II (ACS material)
Participants receive ACS materials only. |
Ancillary studies
Andre navne:
Ancillary studies Receive ACS material
Andre navne:
Ancillary studies |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ability of peer navigation to improve understanding of SCP
Tidsramme: At 6 months
|
Chi-square and t-tests will be used to compare the baseline characteristics of subjects randomized to PN intervention vs control. For subjects in the intervention arm, the number of navigation sessions received will be reported, and correlated factors will be explored. The number of subjects navigated per PN will also be reported. Nonevaluable and evaluable subjects (defined at 6 and 12 months) will be compared. Site of care will be handled as a cluster level variable in generalized linear mixed (GLM) regression models. |
At 6 months
|
|
Adherence to the SCP schedule of follow-up examinations
Tidsramme: At 12 months
|
Measured using a newly created, 50-point scale that gives equal weight to completion of the recommended: physical exams, imaging, pelvic exam, annual oncology visit, and breast self-exams. |
At 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fysisk og sundhedsrelateret QOL
Tidsramme: Ved 6 måneder
|
Ved 6 måneder
|
|
|
Effect of PN on change in medical efficacy
Tidsramme: Baseline to 6 months
|
Exploratory analyses will analyze the effect of PN intervention actually received, using the number of PN sessions completed and the quality of the subject's PN as measured by PN's post-training level of acuity and utility. |
Baseline to 6 months
|
|
Preparedness for life as new survivor (PLANS)
Tidsramme: At 6 months
|
PLANS consists of two subscales that measure patients' knowledge and self efficacy with regards to their Access and Quality of Survivorship Care Plan (SCP) and adherence with regard to following these tasks. The knowledge subscale (Cronbach's alpha 0.90) and adherence subscale (Cronbach's alpha 0.70) have good reliability. |
At 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kimlin Ashing-Giwa, City of Hope Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Hudsygdomme
- Brystsygdomme
- Hud- og bindevævssygdomme
- Brystneoplasmer
- Undersøgelsesteknikker
- Sundhedstjenester
- Sundhedsfaciliteter Arbejdsstyrke og tjenester
- Børns sundhedsydelser
- Fællesskabets sundhedsydelser
- Forebyggende sundhedsydelser
- Adfærdsdiscipliner og aktiviteter
- Mental sundhedsydelser
- Metoder
- Tidlig indgriben, uddannelsesmæssig
- Rådgivning
Andre undersøgelses-id-numre
- 11115
- NCI-2011-03229 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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