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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Cancer
• Intervention / Treatment: Other: interview; Other: clinic visit and interview; Other: interviews and clinic visit

• Study Type: Observational
• Enrollment (Actual): 188

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 15, 2010
• First Submitted That Met QC Criteria: October 18, 2010
• First Posted (Estimate): October 19, 2010

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: VICCREACH1038