SurvivorLink: Scalability of an Electronic Personal Health Record

June 6, 2023 updated by: Ngoc Cam Escoffery, Emory University

SurvivorLink: Scalability of an Electronic Personal Health Record for Cancer Survivors and Caregivers at Pediatric Cancer Centers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Interventions for caregivers and pediatric cancer survivors are needed to improve patient-centered care, minimize late effects and promote overall well-being. The purpose of this research is to assess the impact of the SurvivorLink system on implementation and adherence to cancer care and late effects visits/screening. This research projects proposes to develop a standardized process by which to implement SurvivorLink, a personal electronic health record and education system, designed to promote survivor care, within pediatric cancer clinics. This study will use a Hybrid Type 1 effectiveness-implementation, clustered randomized, waitlist control design to evaluate the impact of SurvivorLink on patient health behavior and quality of life outcomes and understand its delivery among 20 pediatric cancer survivor clinics. The researchers will test the effectiveness of SurvivorLink on 1 year follow-up and completed screenings through a clustered randomized waitlist-control trial: ten clinics will administer the intervention to study participants and the other ten clinics will be a wait-list control group where study participants receive usual care.

The study will evaluate the impact of SurvivorLink on patient survivor care visit attendance and risk-based surveillance tests, caregiver's patient activation, survivor's and caregiver's quality of life and self-efficacy to manage a chronic condition. This study is the first comprehensive, effectiveness-implementation study to evaluate the impact of an electronic personal health record (with care plan) and education system for pediatric cancer survivors and their caregivers.

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
      • Tucson, Arizona, United States, 85719
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Children's Health
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Stead Family Children's Hospital
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University St. Louis Children's Hospital
        • Contact:
    • New York
      • Syracuse, New York, United States, 13210
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • University of Pittsburgh Medical Center (UPMC) Children's Hospital of Pittsburgh
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for Pediatric Cancer Survivor Clinics:

  • 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 patients

Inclusion Criteria for Caregivers of Survivors under 18 Years of Age and for Survivors Aged 18-22:

  • 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

Exclusion Criteria for Caregivers of Survivors under 18 Years of Age and for Survivors Aged 18-22:

  • survivor has a terminal illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SurvivorLink
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
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.
No Intervention: Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of follow-up survivorship visit
Time Frame: Month 12
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
Time Frame: Month 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Activation Measure (PAM) score
Time Frame: Baseline, Month 3, Month 12
The Patient Activation Measure (PAM) is a 10-item survey assessing the patient's or caretaker's knowledge, confidence, and willingness to act concerning their own or their child's health. Respondents indicate how much the agree with health related statements on a scale of 1 (strongly disagree) to 4 (strongly agree). Raw scores range from 10 to 40 and higher scores indicate increased confidence with managing health.
Baseline, Month 3, Month 12
Change in Patient-Reported Outcome Measurement Information System (PROMIS) score
Time Frame: Baseline, Month 3, Month 12
Caregiver quality of life will be assessed with the 10-item Patient-Reported Outcome Measurement Information System (PROMIS), Global Health Short Form. This survey is used to evaluate parents' and caregivers' report of their own physical and mental health quality of life. The scoring system allows each of the individual items to be examined separately to gain information about perceptions of physical, mental, and social health, and general perceptions of health. Respondents rate their level of a variety of aspects of health on a scale of 1 to 5 and rate their level of pain between 0 and 10. Responses to some questions are re-coded so that higher scores reflect better functioning.
Baseline, Month 3, Month 12
Change in intention to seek cancer-related follow-up care
Time Frame: Baseline, Month 3, Month 12
Participants and caregivers will be asked how likely it is that they (or their child) will go to a cancer follow-up visit in the next year. Possible responses include 1 = not sure, 2 =not likely, 3 = likely or 4 = very likely.
Baseline, Month 3, Month 12
Change in Pediatric Quality of Life (PedsQL) Health Care Satisfaction Hematology/Oncology Module score
Time Frame: Baseline, Month 12
Satisfaction with oncology care will be assessed with the 25-item Pediatric Quality of Life (PedsQL) Health Care Satisfaction Hematology/Oncology Module. The module will be used to capture parent's general satisfaction, satisfaction with staff communication and interaction style, satisfaction with information amount and timeliness, and satisfaction with the staff's emotional support for both the patient and parent. Responses are given on a 5-point Likert scale where 1 = very dissatisfied and 5 = very satisfied. Total raw scores range from 25 to 125 and higher scores indicate higher satisfaction.
Baseline, Month 12
Change in Readiness for Transition Questionnaire (RTQ), Adolescent Behavior score
Time Frame: Month 3, Month 12
The survivor's readiness for care transition will be assessed with the Readiness for Transition Questionnaire (RTQ). Adolescent behavior is assessed with 10-items asking participants to rate the level of responsibility that the cancer survivor has for their own care on a scale of 1 (not responsible at all) to 4 (almost always responsible). Total scores for this section range from 10 to 40 with higher scores indicating increased responsibility taken.
Month 3, Month 12
Change in Readiness for Transition Questionnaire (RTQ), Parental Involvement score
Time Frame: Month 3, Month 12
The survivor's readiness for care transition will be assessed with the Readiness for Transition Questionnaire (RTQ) for teens. Parental involvement is assessed with 10-items rating the level of involvement by parents for the health care of the cancer survivor on a scale of 1 (not involved at all) to 4 (almost always involved). Total scores for this section range from 10 to 40 with higher scores indicating increased parental involvement.
Month 3, Month 12
Change in Survivor's PROMIS Scale - Global Health
Time Frame: Month 3, Month 12
The PROMIS -Global Health scale consists of 10 items assessing general domains of health and functioning. The scoring system allows each of the individual items to be examined separately to gain information about perceptions of physical, mental, and social health, and general perceptions of health. Respondents rate their level of a variety of aspects of health on a scale of 1 to 5 and rate their level of pain between 0 and 10. Responses to some questions are re-coded so that higher scores reflect better functioning.
Month 3, Month 12
Change in Self-Efficacy for Managing Chronic Disease score
Time Frame: Baseline, Month 3, Month 12
The Self-Efficacy for Managing Chronic Disease is a 6-item Scale that measures activities related to daily self care in living with a chronic disease. Respondents rate their level of confidence in performing these activities on a scale of 1=not at all to 10=totally confident. Total scores range from 6 to 60 and higher scores indicate increased feelings of self-efficacy.
Baseline, Month 3, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Cam Escoffery, PhD, Emory University
  • Principal Investigator: Ann Mertens, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (Actual)

June 1, 2018

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00101506
  • R01CA218389 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Childhood Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe