Comparing Two Modes of Survivorship Care

Childhood Cancer Clinical Trial

Official title:

Comparing Two Modes of Survivorship Care: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816866
• Other study ID #: 1007007080
• Secondary ID: 119700-RSGHP-10-
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: July 2015

Study information

• Verified date: November 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

Other:
• empowered primary care model
mode of survivorship care
• specialty survivor clinic
mode of survivorship care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Cancer Society, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence to guideline-recommended surveillance (medical record abstraction)	quality of survivorship care	12 months post-intervention
Primary	number of newly-identified late effects of therapy (medical record abstraction)	quality of survivorship care	12 months post-intervention
Secondary	anxiety (Brief Symptom Inventory (BSI))	adverse effects of receiving survivorship care	12 months post-intervention
Secondary	depression (Behavior Assessment System for Children, 2nd Edition (BASC-2))	adverse effects of receiving survivorship care	12 months post-intervention
Secondary	post-traumatic stress symptoms (Post-Traumatic Stress Disorder Reaction Index (PTSD-RI))	adverse effects of receiving survivorship care	12 months post-intervention
Secondary	level of physical activity (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))	adherence to desirable health behaviors	12 months post-intervention
Secondary	avoidance of tobacco (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))	adherence to desirable health behaviors	12 months post-intervention
Secondary	intake of at least five servings per day of fruits and vegetables (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))	adherence to desirable health behaviors	12 months post-intervention