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

NCT01223872 | Completed

• 1 other identifier: VICCREACH1038
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  12 months

• A qualitative evaluation of program feedback will serve to improve the care provided in the REACH for Survivorship clinic

  12 months

Study Arms (3)

Routine Patient Care

Other: interview

Previously-enrolled REACH Clinic Patients

Other: clinic visit and interview

New REACH Clinic Patients

Other: interviews and clinic visit

Interventions

interview OTHER

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

Routine Patient Care

clinic visit and interview OTHER

* REACH Clinic Visit(initial or regular) * Post-REACH Clinic Interview (3mos from initial or regular clinic visit) * Demographic data interview(pre-initial study interview)

Previously-enrolled REACH Clinic Patients

interviews and clinic visit OTHER

* 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)

New REACH Clinic Patients

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who have received a bone marrow transplant

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Interviews as Topic; Ambulatory Care

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 19, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)