Comparing Two Modes of Survivorship Care

NCT ID: NCT02816866

Last Updated: 2020-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-07-31

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.

Detailed Description

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.

Conditions

Childhood Cancer

Keywords

survivorship care; health services; barriers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

empowered primary care model

Intervention Type: OTHER

mode of survivorship care

specialty survivor clinic

patient attends a specialty survivor clinic at Yale for survivorship care

Group Type: EXPERIMENTAL

specialty survivor clinic

Intervention Type: OTHER

mode of survivorship care

Interventions

empowered primary care model

mode of survivorship care

Intervention Type: OTHER

specialty survivor clinic

mode of survivorship care

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nina S Kadan-Lottick, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Yale University

Other Identifiers

119700-RSGHP-10-107-01-CPHPS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1007007080

Identifier Type: -

Identifier Source: org_study_id