Comparing Two Modes of Survivorship Care

Comparing Two Modes of Survivorship Care: A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Childhood Cancer
• Intervention / Treatment: Other: empowered primary care model; Other: specialty survivor 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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: empowered primary care model; mode of survivorship care
Experimental: specialty survivor clinic; patient attends a specialty survivor clinic at Yale for survivorship care	Other: specialty survivor clinic; mode of survivorship care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety (Brief Symptom Inventory (BSI))	adverse effects of receiving survivorship care	12 months post-intervention
depression (Behavior Assessment System for Children, 2nd Edition (BASC-2))	adverse effects of receiving survivorship care	12 months post-intervention
post-traumatic stress symptoms (Post-Traumatic Stress Disorder Reaction Index (PTSD-RI))	adverse effects of receiving survivorship care	12 months post-intervention
level of physical activity (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))	adherence to desirable health behaviors	12 months post-intervention
avoidance of tobacco (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))	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))	adherence to desirable health behaviors	12 months post-intervention

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Nina S Kadan-Lottick, MD, MSPH, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: health services; barriers; survivorship care
• Other Study ID Numbers: 1007007080; 119700-RSGHP-10-107-01-CPHPS (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO