Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience

February 8, 2012 updated by: St. Jude Children's Research Hospital
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

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study sample will be recruited from long-term childhood cancer survivors who are currently participating in the CCSS and whose pediatric malignancy was not treated at St. Jude Children's Research Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cancer Survivors
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: July 2011
July 2011

Secondary Outcome Measures

Outcome Measure
Time Frame
Inform future sample stratification by over-sampling minority and rural-dwelling survivors to enhance the heterogeneity of the respondent pool.
Time Frame: July 2011
July 2011
Describe the met and unmet needs of childhood cancer survivors and their important covariates in a large, stratified random sample of childhood cancer survivors.
Time Frame: July 2011
July 2011
Evaluate the sample selection methods, length of time to complete recruitment, and response rates in the study sample.
Time Frame: July 2011
July 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Cheryl Cox, RN, PhD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INSURE
  • R21CA142921 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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