Childhood CancerNCT01223872
Childhood Cancer Survivors' Knowledge of Diagnosis,Treatment and Risk of Late Effects: Specialized Survivorship Clinic
An observational study of Childhood Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This two-part research study will compare childhood cancer survivors receiving specialized follow-up care in the REACH for Survivorship clinic to patients receiving routine follow-up care. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- interview, clinic visit and interview and interviews and clinic visit
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2015
- Phase
- Observational
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Fifty new cancer patients in the REACH for Survivorship clinic, fifty returning cancer patients in the REACH for Survivorship clinic, and one hundred routine care cancer patients are expected to enroll in this study.
Who may be able to join
- Treatment for primary malignancy per risk-adapted protocol
- Age ≤ 21 years at time of diagnosis
- Currently alive without evidence of disease
- Off therapy for no more than 15 years
Who cannot join
- -Patients who have received a bone marrow transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Childhood Cancer Survivors' Knowledge of Their Diagnosis, Treatment, and Risk of Late Effects: The Impact of Care in a Specialized Survivorship Clinic
This two-part research study will compare childhood cancer survivors receiving specialized follow-up care in the REACH for Survivorship clinic to patients receiving routine follow-up care.
- Conditions
- Childhood Cancer
- Being tested
- interview, clinic visit and interview, interviews and clinic visit
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
- Standard Interview (2-15 years from last treatment)
- Demographic data interview (pre-initial study interview)
clinic visit and interviewOther
- REACH Clinic Visit(initial or regular)
- Post-REACH Clinic Interview (3mos from initial or regular clinic visit)
- Demographic data interview(pre-initial study interview)
interviews and clinic visitOther
- Pre-REACH Clinic Interview(2-15 yrs from last treatment)
- REACH Clinic Visit(initial or regular)
- Post-REACH Clinic Interview(1mo from initial clinic visit)
- Post-REACH Clinic Interview(3mos from initial or regular clinic visit)
- Demographic data interview(pre-initial study interview)
| Study group | Role | What they receive |
|---|---|---|
| Routine Patient Care | Not described Receives: Other: interview | |
| Previously-enrolled REACH Clinic Patients | Not described Receives: Other: clinic visit and interview | |
| New REACH Clinic Patients | Not described Receives: Other: interviews and clinic visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge gained by attending a multispecialty Survivorship Clinic which will be measured by comparison of self report with medical record data in both cross-sectional and longitudinal approach.
In addition to data from patient interviews, a review of medical records will include general patient demographic data as well as data regarding cancer diagnosis, treatment and ongoing follow-up care.
Measured: 12 months
Secondary outcomes (3)
Characterizing how the initial consultation in a specialized clinic impacts childhood cancer survivors' knowledge of their cancer diagnosis, treatment, and risk of late effects by comparing patient's understanding among 3 sampled timepoints.
Measured: pre-clinic and a post-clinic interviews at 1 and 3 months.
An analysis of differences in relative levels of recommended screening for late effects that childhood cancer survivors have received based on the type of their long-term follow-up care comparing medical records against Survivorship Care Plan.
Scored responses will allow for quantitative analysis of differences within and between the cohorts of patients
Measured: 12 months
A qualitative evaluation of program feedback will serve to improve the care provided in the REACH for Survivorship clinic
This data will be evaluated qualitatively for trends.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2015
- Study completionAug 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 Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223872
- Sponsor's protocol ID
- VICCREACH1038
- Status last verified
- Mar 2017
- First submitted
- 15 Oct 2010
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Cancer Survivors' Knowledge of Their Diagnosis, Treatment, and Risk of Late Effects: The Impact of Care in a Specialized Survivorship Clinic
- ClinicalTrials.gov ID
- NCT01223872
- Acronym / sponsor ID
- VICCREACH1038
- Conditions
- Childhood Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Oct 2010 (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.
This two-part research study will compare childhood cancer survivors receiving specialized follow-up care in the REACH for Survivorship clinic to patients receiving routine follow-up care.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine Patient Care | – | Other: interview |
| Previously-enrolled REACH Clinic Patients | – | Other: clinic visit and interview |
| New REACH Clinic Patients | – | Other: interviews and clinic visit |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Fifty new cancer patients in the REACH for Survivorship clinic, fifty returning cancer patients in the REACH for Survivorship clinic, and one hundred routine care cancer patients are expected to enroll in this study.
Key inclusion criteria (4 listed)
- Treatment for primary malignancy per risk-adapted protocol
- Age ≤ 21 years at time of diagnosis
- Currently alive without evidence of disease
- Off therapy for no more than 15 years
Key exclusion criteria (1 listed)
- -Patients who have received a bone marrow transplant
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 |
|---|---|---|
| interview* Standard Interview (2-15 years from last treatment) * Demographic data interview (pre-initial study interview) | Other | Routine Patient Care |
| clinic visit and interview* REACH Clinic Visit(initial or regular) * Post-REACH Clinic Interview (3mos from initial or regular clinic visit) * Demographic data interview(pre-initial study interview) | Other | Previously-enrolled REACH Clinic Patients |
| interviews and clinic visit* Pre-REACH Clinic Interview(2-15 yrs from last treatment) * REACH Clinic Visit(initial or regular) * Post-REACH Clinic Interview(1mo from initial clinic visit) * Post-REACH Clinic Interview(3mos from initial or regular clinic visit) * Demographic data interview(pre-initial study interview) | Other | New REACH Clinic Patients |
Primary outcome
Knowledge gained by attending a multispecialty Survivorship Clinic which will be measured by comparison of self report with medical record data in both cross-sectional and longitudinal approach.
Time frame: 12 months
In addition to data from patient interviews, a review of medical records will include general patient demographic data as well as data regarding cancer diagnosis, treatment and ongoing follow-up care.
3 secondary outcomes
Characterizing how the initial consultation in a specialized clinic impacts childhood cancer survivors' knowledge of their cancer diagnosis, treatment, and risk of late effects by comparing patient's understanding among 3 sampled timepoints.
Time frame: pre-clinic and a post-clinic interviews at 1 and 3 months.
An analysis of differences in relative levels of recommended screening for late effects that childhood cancer survivors have received based on the type of their long-term follow-up care comparing medical records against Survivorship Care Plan.
Time frame: 12 months
A qualitative evaluation of program feedback will serve to improve the care provided in the REACH for Survivorship clinic
Time frame: 12 months
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 4 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer, run by Vanderbilt University Medical Center at 1 site 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 4 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Knowledge gained by attending a multispecialty Survivorship Clinic which will be measured by comparison of self report with medical record data in both cross-sectional and longitudinal approach. (time frame: 12 months). 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 4 Apr 2017.