SurvivorLink: Scalability of an Electronic Personal Health Record

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Childhood Cancer

Intervention / Treatment
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* Behavioral: SurvivorLink


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SurvivorLink<br>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<br>* 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.<br>|
| No Intervention: Usual care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Survivor's PROMIS Scale - Global Health | 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 | 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 | 
| Change in Patient Activation Measure (PAM) score | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer survivor, Health promotion, Health education