SurvivorLink: Scalability of an Electronic Personal Health Record

NCT03543852 | Completed DMC

• 2 other identifiers: IRB00101506R01CA218389
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 12

Brief Summary

Previous research suggests that children and adolescents with cancer are at heightened risk of late effects that can occur months or years after cancer treatment, yet little is known about programs that increase their return for follow-up cancer care and late effects surveillance. This study will evaluate the impact of an electronic personal health record and education system, SurvivorLink, for pediatric cancer survivors and their caregivers. The researchers will develop a standardized intervention and training for the SurvivorLink trial, followed by conducting a Hybrid Type 1 effectiveness-implementation, clustered randomized, waitlist control trial to evaluate the impact of SurvivorLink on pediatric cancer patients' one year follow-up visits and completion of screening tests. The study will also assess the impact of SurvivorLink on caregiver's patient activation, survivor's and caregiver's quality of life, and self-efficacy to manage a chronic condition. This study will provide the evidence base about the effects of the system to improve follow-up care for children and adolescents with cancer and best practices for implementation for pediatric cancer centers.

Conditions

Childhood Cancer

Keywords

Cancer survivor; Health promotion; Health education

Outcome Measures

Primary Outcomes (2)

• Completion of follow-up survivorship visit

  The number of participants completing the follow-up survivorship visit will be determined from medical records and compared between study arms.

  Month 12

• Completion of recommended screening tests

  The number of participants completing their risk based cancer care (such as screenings and tests) will be determined from medical records and compared between study arms.

  Month 12

Secondary Outcomes (8)

• Patient Activation Measure (PAM) score

  Baseline, Month 3, Month 12

• Patient-Reported Outcome Measurement Information System (PROMIS) score

  Baseline, Month 3, Month 12

• Intention to seek cancer-related follow-up care

  Baseline, Month 3, Month 12

• Pediatric Quality of Life (PedsQL) Health Care Satisfaction Hematology/Oncology Module score

  Baseline, Month 12

• Readiness for Transition Questionnaire (RTQ), Adolescent Behavior score

  Month 3, Month 12

Study Arms (2)

SurvivorLink

EXPERIMENTAL

Participants receiving treatment at a pediatric cancer survivor clinic randomized to this study arm will receive education on how to use SurvivorLink, late effects of treatment, and survivorship care through the system.

Behavioral: SurvivorLink

Usual care

NO INTERVENTION

Participants receiving treatment at a pediatric cancer survivor clinic randomized to the usual care study arm will receive the SurvivorLink intervention beginning at Month 12.

Interventions

SurvivorLink BEHAVIORAL

SurvivorLink (www.cancersurvivorlink.org) was developed in 2010 as a HIPAA compliant web-based communication tool to enable survivors to learn about survivorship care, store their SHP and other important health documents, and share their SHP and other health documents with their various healthcare providers. Once the registrant creates their health record, they can upload and store their important health documents and electronically share their health record with their providers. Other key features include a provider directory for patients to find physicians knowledgeable of survivor care, additional patient/parent material available in English/Spanish, and additional continuing medical education (CME) modules for providers to learn about survivor care.

SurvivorLink

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• have a designated survivorship clinic and provide a survivor healthcare plan (SHP) to survivors seen in clinic
• have \> 100 pediatric cancer survivors seen annually
• be willing to become a SurvivorLink partner clinic and complete a Business Associates Agreement with Emory University
• able to enroll 75 caregivers or young adult patients
• pediatric cancer survivor completed treatment in past year
• English or Spanish speaking
• able to access the internet either with a computer or smartphone
• gives permission for the clinic and study staff to use clinical data to confirm service utilization patterns
• gives permission to view SHP records on SurvivorLink

You may not qualify if:

• survivor has a terminal illness

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Banner University Medical Center in Tucson

Tucson, Arizona, 85719, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

University of Chicago Medicine Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Riley Children's Health

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, 52242, United States

Location

Washington University St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Upstate Medical University

Syracuse, New York, 13210, United States

Location

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh Medical Center (UPMC) Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Neoplasms; Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Cam Escoffery, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 20 pediatric cancer survivor clinics will be pair matched based on patient population size, level of current survivorship care, and location (urban/rural). The pairs will be randomized to receive the intervention immediately or after 12 months. Selection and randomization of clinics will occur in 2019. Participants (survivors aged 18-22, or caretakers of survivors under age 18) will be recruited from the participating centers.

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: June 14, 2021
• Primary Completion: December 15, 2024
• Study Completion: December 25, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)