Childhood CancerNCT03543852
SurvivorLink: Scalability of an Electronic Personal Health Record
A study testing SurvivorLink in people with Childhood Cancer, run by Emory University at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- SurvivorLink
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 12 sitesUnited States
- Study dates
- 14 Jun 2021to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Inclusion Criteria for Caregivers of Survivors under 18 Years of Age, Adolescent Survivors Aged 15-17, and Survivors Aged 18-21:
- pediatric cancer survivor completed treatment in past year
Show all 12Show fewer
- 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, Adolescent Survivors Aged 15-17, and Survivors Aged 18-21:
- survivor has a terminal illness
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Chicago Medicine Comer Children's Hospital
Chicago, Illinois, 60637
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Riley Children's Health
Indianapolis, Indiana, 46202
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, 52242
Children's Hospital of Orange County
Orange, California, 92868
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Phoenix Children's Hospital
Phoenix, Arizona, 85016
University of Pittsburgh Medical Center (UPMC) Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Washington University St. Louis Children's Hospital
St Louis, Missouri, 63110
Upstate Medical University
Syracuse, New York, 13210
Banner University Medical Center in Tucson
Tucson, Arizona, 85719
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read the detailed description
Currently, there are over 388,000 cancer survivors who are diagnosed under the age of 21. Individuals who have survived a diagnosis of cancer exemplify a complex patient population who would benefit from incorporation of an electronic personal health record (ePHR) into their chronic disease management care. Survivor care is especially important for survivors of pediatric cancers, where the overall cure rate is over 80%. To aid in the timely and appropriate surveillance of pediatric cancer survivors, the Children's Oncology Group (COG) developed Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent and Young Adult Cancers (LTFU Guidelines). The LTFU Guidelines can be used to create a Survivorship Care Plan (SCP) for each survivor which supplies an individualized, evidence-based roadmap for survivor care and surveillance. The Institute of Medicine (IOM) recommends all cancer patients should receive a SCP; however, scant research has explored how interventions which provide summary care documents have impacted a survivor's utilization of health care, and adherence to healthy behaviors and surveillance guidelines.
The researcher developed SurvivorLink in 2010 as a HIPAA compliant web-based communication tool to enable survivors to learn about survivorship care, store their SCP and other important health documents, and share their SCP and other health documents with their various healthcare providers. SurvivorLink is a completely patient-controlled electronic personal health record (PHR) - parents of survivors <18 years old and survivors ≥18 years must register and create their own heath record. 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 regardless of where they practice. Patients can also select the clinic where they receive their survivor care and complete the medical record process to allow their clinic to upload documents to their health record. Currently, Children's Healthcare of Atlanta (CHOA) is the only survivor clinic with this functionality available. However, SurvivorLink was built with the capability to easily add additional clinics.
In this study, the researchers plan to perform the implementation process of adding additional clinics with their own clinical portals to SurvivorLink. The addition will allow the clinics to recruit their patients to use SurvivorLink. Each survivor clinic will be able to independently manage their own patient users and medical record releases. The overall goal of this research is to contribute to literature about technological interventions that impact supportive and long-term care for pediatric cancer survivors and advance conceptual thinking about context impacts on implementation.
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 project 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.
- Conditions
- Childhood Cancer
- Being tested
- SurvivorLink
- Keywords
- Cancer survivor, Health promotion, Health education
- Medical subject headings
- Neoplasms, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurvivorLinkBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Completing Follow-up Survivorship Visit
The percentage of participants completing the follow-up survivorship visit was determined from medical records.
Measured: Month 12
Percentage of Survivors Completing Recommended Screening Tests
The percentage of young adult and pediatric cancer survivor participants completing their risk-based cancer care (such as screenings and tests) was determined from medical records.
Measured: Month 12
Secondary outcomes (6)
Patient Activation Measure (PAM) Score
The Patient Activation Measure (PAM) is a 10-item survey assessing the young adult 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.
Measured: Baseline, Month 3, Month 12
Patient-Reported Outcome Measurement Information System (PROMIS) Score for Cancer Survivors
Quality of life is assessed with the 10-item Patient-Reported Outcome Measurement Information System (PROMIS), Global Health Short Form. This survey is used to evaluate physical and mental health quality of life. Young adult survivors reported completed their own survey while caregivers completed the survey for pediatric cancer survivors. 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. Raw sum scores are converted to T scores with a mean of 50 and a standard deviation of 10. Values greater than 50 indicate greater than average function while scores lower than 50 indicate greater distress.
Measured: Baseline, Month 3, Month 12
Intention to Seek Cancer-related Follow-up Care
Young adult cancer survivors and caregivers were asked how likely it was that they (or their child) will go to a cancer follow-up visit in the next year. Possible responses include 1 = not likely at all, 2 =not very likely, 3 = somewhat likely, 4 = very likely, or 5 = extremely likely.
Measured: Baseline, Month 3, Month 12
Pediatric Quality of Life (PedsQL) Health Care Satisfaction Hematology/Oncology Module Score
Satisfaction with oncology care is assessed with the 25-item Pediatric Quality of Life (PedsQL) Health Care Satisfaction Hematology/Oncology Module. The module will be used to capture 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. The sum of all scores is used to calculate a mean score which ranges from 1 to 5 where higher scores indicate higher satisfaction.
Measured: Baseline, Month 12
Patient-Reported Outcome Measurement Information System (PROMIS) Score for Caregivers
The PROMIS -Global Health scale consists of 10 items assessing general domains of health and functioning. This survey is used to evaluate physical and mental health quality of life of caregivers of pediatric cancer survivors. 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. Raw sum scores are converted to T scores with a mean of 50 and a standard deviation of 10. Values greater than 50 indicate greater than average function while scores lower than 50 indicate greater distress.
Measured: Month 3, Month 12
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. A mean score is calculated, ranging from 1 to 10, where higher scores indicate increased feelings of self-efficacy.
Measured: Baseline, Month 3, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start14 Jun 2021
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ngoc Cam Escoffery, Emory University
- Investigators
- Cam Escoffery, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543852
- Sponsor's protocol ID
- IRB00101506
- Other IDs
- R01CA218389, 2025P013371
- Status last verified
- Oct 2026
- First submitted
- 21 May 2018
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Escoffery C, Gilleland Marchak J, Haardorfer R, Meacham L, Williamson Lewis R, Udelson H, Edwards P, Mertens AC. Scalability of cancer SurvivorLink: A cluster randomized trial among pediatric cancer clinics. Contemp Clin Trials. 2019 Oct;85:105819. doi: 10.1016/j.cct.2019.105819. Epub 2019 Aug 7.
PubMed 31400518
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SurvivorLink: Scalability of an Electronic Personal Health Record for Cancer Survivors and Caregivers at Pediatric Cancer Centers
- ClinicalTrials.gov ID
- NCT03543852
- Acronym / sponsor ID
- IRB00101506
- Conditions
- Childhood Cancer
- Keywords
- Cancer survivor, Health promotion, Health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Currently, there are over 388,000 cancer survivors who are diagnosed under the age of 21. Individuals who have survived a diagnosis of cancer exemplify a complex patient population who would benefit from incorporation of an electronic personal health record (ePHR) into their chronic disease management care. Survivor care is especially important for survivors of pediatric cancers, where the overall cure rate is over 80%. To aid in the timely and appropriate surveillance of pediatric cancer survivors, the Children's Oncology Group (COG) developed Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent and Young Adult Cancers (LTFU Guidelines). The LTFU Guidelines can be used to create a Survivorship Care Plan (SCP) for each survivor which supplies an individualized, evidence-based roadmap for survivor care and surveillance. The Institute of Medicine (IOM) recommends all cancer patients should receive a SCP; however, scant research has explored how interventions which provide summary care documents have impacted a survivor's utilization of health care, and adherence to healthy behaviors and surveillance guidelines.
The researcher developed SurvivorLink in 2010 as a HIPAA compliant web-based communication tool to enable survivors to learn about survivorship care, store their SCP and other important health documents, and share their SCP and other health documents with their various healthcare providers. SurvivorLink is a completely patient-controlled electronic personal health record (PHR) - parents of survivors <18 years old and survivors ≥18 years must register and create their own heath record. 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 regardless of where they practice. Patients can also select the clinic where they receive their survivor care and complete the medical record process to allow their clinic to upload documents to their health record. Currently, Children's Healthcare of Atlanta (CHOA) is the only survivor clinic with this functionality available. However, SurvivorLink was built with the capability to easily add additional clinics.
In this study, the researchers plan to perform the implementation process of adding additional clinics with their own clinical portals to SurvivorLink. The addition will allow the clinics to recruit their patients to use SurvivorLink. Each survivor clinic will be able to independently manage their own patient users and medical record releases. The overall goal of this research is to contribute to literature about technological interventions that impact supportive and long-term care for pediatric cancer survivors and advance conceptual thinking about context impacts on implementation.
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 project 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SurvivorLink | Experimental | Behavioral: SurvivorLinkParticipants 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. |
| 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Inclusion Criteria for Caregivers of Survivors under 18 Years of Age, Adolescent Survivors Aged 15-17, and Survivors Aged 18-21:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurvivorLinkSurvivorLink (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. | Behavioural | SurvivorLink |
Primary outcome
Percentage of Participants Completing Follow-up Survivorship Visit
Time frame: Month 12
The percentage of participants completing the follow-up survivorship visit was determined from medical records.
Percentage of Survivors Completing Recommended Screening Tests
Time frame: Month 12
The percentage of young adult and pediatric cancer survivor participants completing their risk-based cancer care (such as screenings and tests) was determined from medical records.
6 secondary outcomes
Patient Activation Measure (PAM) Score
Time frame: Baseline, Month 3, Month 12
Patient-Reported Outcome Measurement Information System (PROMIS) Score for Cancer Survivors
Time frame: Baseline, Month 3, Month 12
Intention to Seek Cancer-related Follow-up Care
Time frame: Baseline, Month 3, Month 12
Pediatric Quality of Life (PedsQL) Health Care Satisfaction Hematology/Oncology Module Score
Time frame: Baseline, Month 12
Patient-Reported Outcome Measurement Information System (PROMIS) Score for Caregivers
Time frame: Month 3, Month 12
Self-Efficacy for Managing Chronic Disease Score
Time frame: Baseline, Month 3, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31400518Escoffery C, Gilleland Marchak J, Haardorfer R, Meacham L, Williamson Lewis R, Udelson H, Edwards P, Mertens AC. Scalability of cancer SurvivorLink: A cluster randomized trial among pediatric cancer clinics. Contemp Clin Trials. 2019 Oct;85:105819. doi: 10.1016/j.cct.2019.105819. Epub 2019 Aug 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cam Escoffery, PhD principal investigator
Emory University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SurvivorLink in people with Childhood Cancer, run by Emory University at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Completing Follow-up Survivorship Visit (time frame: Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.