Childhood Cancer Survivors' Knowledge of Diagnosis,Treatment and Risk of Late Effects: Specialized Survivorship Clinic

This study is currently recruiting participants.

Verified July 2011 by Vanderbilt University

Sponsor:

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01223872

First received: October 15, 2010

Last updated: July 14, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2010

Last Updated Date

July 14, 2011

Start Date ^ICMJE

August 2010

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01223872 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Scored responses will allow for quantitative analysis of differences within and between the cohorts of patients
A qualitative evaluation of program feedback will serve to improve the care provided in the REACH for Survivorship clinic [ Time Frame: 12 months ] [ Designated as safety issue: No ]
This data will be evaluated qualitatively for trends.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Childhood Cancer Survivors' Knowledge of Diagnosis,Treatment and Risk of Late Effects: Specialized Survivorship Clinic

Official Title ^ICMJE

Childhood Cancer Survivors' Knowledge of Their Diagnosis, Treatment, and Risk of Late Effects: The Impact of Care in a Specialized Survivorship Clinic

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

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.

Condition ^ICMJE

Childhood Cancer

Intervention ^ICMJE

Other: interview
- Standard Interview (2-15 years from last treatment)
- Demographic data interview (pre-initial study interview)
Other: 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: 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)

Study Group/Cohort (s)

Routine Patient Care
Intervention: Other: interview
Previously-enrolled REACH Clinic Patients
Intervention: Other: clinic visit and interview
New REACH Clinic Patients
Intervention: Other: interviews and clinic visit

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

August 2016

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

-Patients who have received a bone marrow transplant

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Robert Lindell, MD		robert.b.lindell@vanderbilt.edu
Contact: Debra Friedman, MD		debra.l.friedman@vanderbilt.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01223872

Other Study ID Numbers ^ICMJE

VICCREACH1038

Has Data Monitoring Committee

Responsible Party

Robert Lindell,MD, Vanderbilt-Ingram Cancer Center

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Vanderbilt University

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top