Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience

Childhood Cancer Clinical Trial

Official title:

Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073735
• Other study ID #: INSURE
• Secondary ID: R21CA142921
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: February 8, 2012
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This feasibility study will determine the psychometric adequacy of a newly developed instrument - Childhood Cancer Survivor Study Needs Assessment Questionnaire (CCSS-NAQ). Additionally, the study will explore the feasibility of selected study methods -- sample selection, length of time to complete recruitment, and response rates - in order to inform a larger national periodic survey of adult survivors' health related needs

Description:

This study will focus on the following primary and secondary objectives:

1. Examine the construct validity, short-term stability, internal consistency and item-response performance of a health-related needs assessment self-report instrument for adult childhood cancer survivors

2. Inform future sample stratification by over-sampling minority and rural-dwelling survivors to enhance the heterogeneity of the respondent pool;

3. Describe the met and unmet health-related needs and their covariates in a large, stratified, random sample of childhood cancer survivors;

4. Evaluate the sample selection methods, length of time to complete recruitment, and response rates in the study sample.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1178
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

1. Living CCSS participant

2. Age 25 years or older on December 31, 2009

3. History of successful independent (non-surrogate) response to previous CCSS surveys (Flesch-Kincaid reading level for non-medical items established at 4th-6th grade).

Exclusion Criteria:

Received treatment for pediatric malignancy at St. Jude Children's Research Hospital.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Childhood Cancer

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine the construct validity, internal consistency, item-response performance, and short-term stability of a health-related needs assessment self-report instrument for adult childhood cancer survivors.		July 2011	No
Secondary	Inform future sample stratification by over-sampling minority and rural-dwelling survivors to enhance the heterogeneity of the respondent pool.		July 2011	No
Secondary	Describe the met and unmet needs of childhood cancer survivors and their important covariates in a large, stratified random sample of childhood cancer survivors.		July 2011	No
Secondary	Evaluate the sample selection methods, length of time to complete recruitment, and response rates in the study sample.		July 2011	No

External Links

•   St. Jude Children's Research Hospital