- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02816866
Comparing Two Modes of Survivorship Care
Comparing Two Modes of Survivorship Care: A Randomized Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Although 80% of children with cancer will be cured of their primary disease, at least 70% of survivors will develop chronic medical, neurocognitive, and/or emotional conditions as a complication of their therapy. Most of these conditions are amenable to prevention and early intervention. In response, the Institute of Medicine strongly advised that all cancer patients should receive survivorship care with the following key elements: 1) a summary of previous cancer therapy, 2) individualized life-long screening for potential adverse therapy-related effects, and 3) education regarding desirable health behaviors. However, less than 30% of survivors receive recommended care. There is a tremendous need for research that addresses how to best implement evidence-based recommendations for this population.
Two main health care delivery models have been advocated for survivorship care, but no comparison studies exist. The first model is a specialty survivor clinic, usually at a cancer treatment center. The second model, termed the empowered primary care model, involves patients receiving an individualized "prescription" for follow-up care prepared by a cancer survivor specialist to be implemented by the primary care doctor. Each model poses unique strengths and weaknesses. Specialty survivor clinics can be expensive and geographically inaccessible, can cause anxiety and stress to patients, and can accommodate limited numbers of patients. Primary care doctors may lack adequate expertise and time for these complex patients. Unless we know how these approaches compare with regard to quality of care and risks, advocates and policy makers will be stymied in their efforts to support the health needs of cancer survivors. This study seeks to compare subjects randomized to the empowered primary care model vs. a specialty survivor clinic.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosis of any malignancy at age <18 years and reported to Yale-New Haven Hospital or Connecticut Children's Medical Center (CCMC) tumor registry
- Currently alive and cancer-free
- Primary residence within approximately 100 miles of Yale-New Haven Hospital or CCMC
- ≥ 1 year status post completion of all cancer-related therapy
- Elapsed time of less than 12.0 years since diagnosis of malignancy
- Speaking and writing knowledge of English. For subjects <18 years, at least one parent must satisfy this requirement.
- No previous attendance at the Yale HEROS or CCMC Reach for the STARS survivorship clinics, or other specialty survivorship clinic
Exclusion Criteria:
- n/a
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: empowered primary care model
patients receive an individualized "prescription" for survivorship care prepared by a cancer survivor specialist to be implemented by the primary care doctor
|
mode of survivorship care
|
Eksperimentell: specialty survivor clinic
patient attends a specialty survivor clinic at Yale for survivorship care
|
mode of survivorship care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
adherence to guideline-recommended surveillance (medical record abstraction)
Tidsramme: 12 months post-intervention
|
quality of survivorship care
|
12 months post-intervention
|
number of newly-identified late effects of therapy (medical record abstraction)
Tidsramme: 12 months post-intervention
|
quality of survivorship care
|
12 months post-intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
anxiety (Brief Symptom Inventory (BSI))
Tidsramme: 12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
depression (Behavior Assessment System for Children, 2nd Edition (BASC-2))
Tidsramme: 12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
post-traumatic stress symptoms (Post-Traumatic Stress Disorder Reaction Index (PTSD-RI))
Tidsramme: 12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
level of physical activity (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
Tidsramme: 12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
avoidance of tobacco (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
Tidsramme: 12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
intake of at least five servings per day of fruits and vegetables (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
Tidsramme: 12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nina S Kadan-Lottick, MD, MSPH, Yale School of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 1007007080
- 119700-RSGHP-10-107-01-CPHPS (Annet stipend/finansieringsnummer: American Cancer Society)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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