Peer Navigator utbildning i att förbättra överlevnadsvården hos afroamerikanska bröstcanceröverlevande
Sister Survivor: Förbättring av överlevnadsvården för afroamerikanska kvinnor med bröstcancer
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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Duarte, California, Förenta staterna, 91010
- City of Hope Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
Ancillary studies Receive ACS material
Andra namn:
Undergo PN session
Andra namn:
Ancillary studies |
|
Aktiv komparator: Arm II (ACS material)
Participants receive ACS materials only. |
Ancillary studies
Andra namn:
Ancillary studies Receive ACS material
Andra namn:
Ancillary studies |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ability of peer navigation to improve understanding of SCP
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fysisk och hälsorelaterad QOL
Tidsram: Vid 6 månader
|
Vid 6 månader
|
|
|
Effect of PN on change in medical efficacy
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kimlin Ashing-Giwa, City of Hope Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Hudsjukdomar
- Bröstsjukdomar
- Hud- och bindvävssjukdomar
- Bröstneoplasmer
- Undersökningstekniker
- Vårdtjänster
- Sjukvårdsanläggningar och tjänster
- Barnhälsotjänster
- Gemenskapens hälsovård
- Förebyggande hälsovårdstjänster
- Beteendediscipliner och aktiviteter
- Mentalvårdstjänster
- Metoder
- Tidig intervention, pedagogisk
- Rådgivning
Andra studie-ID-nummer
- 11115
- NCI-2011-03229 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
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