Comparing Two Modes of Survivorship Care

NCT02816866 | Completed

• 2 other identifiers: 1007007080119700-RSGHP-10-107-01-CPHPS
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this study is to research the comparative effectiveness of two potential models of health care to deliver preventive services and chronic care management to the growing population of adult and pediatric survivors of childhood cancer. The central hypothesis is that survivorship care delivered by a subject's primary care doctor after the subject is empowered with individualized follow-up recommendations prepared by a cancer survivor specialist is similar to care provided in a specialty survival clinic.

Conditions

Childhood Cancer

Keywords

survivorship care; health services; barriers

Outcome Measures

Primary Outcomes (2)

• adherence to guideline-recommended surveillance (medical record abstraction)

  quality of survivorship care

  12 months post-intervention

• number of newly-identified late effects of therapy (medical record abstraction)

  quality of survivorship care

  12 months post-intervention

Secondary Outcomes (6)

• anxiety (Brief Symptom Inventory (BSI))

  12 months post-intervention

• depression (Behavior Assessment System for Children, 2nd Edition (BASC-2))

  12 months post-intervention

• post-traumatic stress symptoms (Post-Traumatic Stress Disorder Reaction Index (PTSD-RI))

  12 months post-intervention

• level of physical activity (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))

  12 months post-intervention

• avoidance of tobacco (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))

  12 months post-intervention

Study Arms (2)

empowered primary care model

EXPERIMENTAL

patients receive an individualized "prescription" for survivorship care prepared by a cancer survivor specialist to be implemented by the primary care doctor

Other: empowered primary care model

specialty survivor clinic

EXPERIMENTAL

patient attends a specialty survivor clinic at Yale for survivorship care

Other: specialty survivor clinic

Interventions

empowered primary care model OTHER

mode of survivorship care

empowered primary care model

specialty survivor clinic OTHER

mode of survivorship care

specialty survivor clinic

Eligibility Criteria

• Age: 1 Year - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• n/a

Sponsors & Collaborators

• Yale University: lead
• American Cancer Society, Inc.: collaborator

MeSH Terms

Conditions

Neoplasms

Study Officials

• Nina S Kadan-Lottick, MD, MSPH

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 29, 2016
• Study Start: July 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share