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

Childhood Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223872
• Other study ID #: VICCREACH1038
• Status: Completed
• Phase: N/A
• First received: October 15, 2010
• Last updated: March 30, 2017
• Start date: August 2010
• Est. completion date: August 2015

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.		pre-clinic and a post-clinic interviews at 1 and 3 months.
Secondary	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	12 months
Secondary	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.	12 months