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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT01223872
First received: October 15, 2010
Last updated: March 30, 2017
Last verified: March 2017
  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
Time Perspective: Other
Official Title: Childhood Cancer Survivors' Knowledge of Their Diagnosis, Treatment, and Risk of Late Effects: The Impact of Care in a Specialized Survivorship Clinic

Further study details as provided by Vanderbilt University Medical Center:

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 ]
    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. ]
  • 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 ]
    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 ]
    This data will be evaluated qualitatively for trends.


Enrollment: 188
Study Start Date: August 2010
Study Completion Date: August 2015
Primary Completion Date: June 2015 (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   (Child, Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
  More Information

Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01223872     History of Changes
Other Study ID Numbers: VICCREACH1038
Study First Received: October 15, 2010
Last Updated: March 30, 2017

ClinicalTrials.gov processed this record on August 18, 2017