Childhood CancerNCT02816866
Comparing Two Modes of Survivorship Care
A study testing empowered primary care model and specialty survivor clinic in people with Childhood Cancer, run by Yale University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- empowered primary care model and specialty survivor clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- n/a
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Cancer
- Being tested
- empowered primary care model, specialty survivor clinic
- Keywords
- survivorship care, health services, barriers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empowered primary care modelOther
mode of survivorship care
specialty survivor clinicOther
mode of survivorship care
| Study group | Role | What they receive |
|---|---|---|
| empowered primary care model | Experimental | patients receive an individualized "prescription" for survivorship care prepared by a cancer survivor specialist to be implemented by the primary care doctor Receives: Other: empowered primary care model |
| specialty survivor clinic | Experimental | patient attends a specialty survivor clinic at Yale for survivorship care Receives: Other: specialty survivor clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to guideline-recommended surveillance (medical record abstraction)
quality of survivorship care
Measured: 12 months post-intervention
number of newly-identified late effects of therapy (medical record abstraction)
quality of survivorship care
Measured: 12 months post-intervention
Secondary outcomes (6)
anxiety (Brief Symptom Inventory (BSI))
adverse effects of receiving survivorship care
Measured: 12 months post-intervention
depression (Behavior Assessment System for Children, 2nd Edition (BASC-2))
adverse effects of receiving survivorship care
Measured: 12 months post-intervention
post-traumatic stress symptoms (Post-Traumatic Stress Disorder Reaction Index (PTSD-RI))
adverse effects of receiving survivorship care
Measured: 12 months post-intervention
level of physical activity (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
adherence to desirable health behaviors
Measured: 12 months post-intervention
avoidance of tobacco (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
adherence to desirable health behaviors
Measured: 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
Measured: 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJul 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Yale 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Nina S Kadan-Lottick, MD, MSPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816866
- Sponsor's protocol ID
- 1007007080
- Other IDs
- 119700-RSGHP-10-107-01-CPHPS
- Status last verified
- Nov 2020
- First submitted
- 17 Jun 2016
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Modes of Survivorship Care: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02816866
- Acronym / sponsor ID
- 1007007080
- Conditions
- Childhood Cancer
- Keywords
- survivorship care, health services, barriers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jul 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| empowered primary care model | Experimental | Other: empowered primary care modelpatients receive an individualized "prescription" for survivorship care prepared by a cancer survivor specialist to be implemented by the primary care doctor |
| specialty survivor clinic | Experimental | Other: specialty survivor clinicpatient attends a specialty survivor clinic at Yale for survivorship care |
Who may qualify
- Ages
- 1 year to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| empowered primary care modelmode of survivorship care | Other | empowered primary care model |
| specialty survivor clinicmode of survivorship care | Other | specialty survivor clinic |
Primary outcome
adherence to guideline-recommended surveillance (medical record abstraction)
Time frame: 12 months post-intervention
quality of survivorship care
number of newly-identified late effects of therapy (medical record abstraction)
Time frame: 12 months post-intervention
quality of survivorship care
6 secondary outcomes
anxiety (Brief Symptom Inventory (BSI))
Time frame: 12 months post-intervention
depression (Behavior Assessment System for Children, 2nd Edition (BASC-2))
Time frame: 12 months post-intervention
post-traumatic stress symptoms (Post-Traumatic Stress Disorder Reaction Index (PTSD-RI))
Time frame: 12 months post-intervention
level of physical activity (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
Time frame: 12 months post-intervention
avoidance of tobacco (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
Time frame: 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))
Time frame: 12 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- 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.
Nina S Kadan-Lottick, MD, MSPH principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing empowered primary care model and specialty survivor clinic in people with Childhood Cancer, run by Yale University.
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 7 inclusion and 1 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
adherence to guideline-recommended surveillance (medical record abstraction) (time frame: 12 months post-intervention). 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?
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 19 Nov 2020.