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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
  Purpose

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.


Condition Intervention
Childhood Cancer
 Other: interview
Other: clinic visit and interview
Other: interviews and clinic visit

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Childhood Cancer Survivors' Knowledge of Their Diagnosis, Treatment, and Risk of Late Effects: The Impact of Care in a Specialized Survivorship Clinic

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 160
Study Start Date: August 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Routine Patient Care Other: interview
  • Standard Interview (2-15 years from last treatment)
  • Demographic data interview (pre-initial study interview)
Previously-enrolled REACH Clinic Patients 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)
New REACH Clinic Patients 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)

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223872

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

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Robert Lindell, MD         robert.b.lindell@vanderbilt.edu    
Contact: Debra Friedman, MD         debra.l.friedman@vanderbilt.edu    
Principal Investigator: Robert Lindell, MD            
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Robert Lindell,MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01223872     History of Changes
Other Study ID Numbers: VICCREACH1038
Study First Received: October 15, 2010
Last Updated: July 14, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013