Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01073735
First received: February 22, 2010
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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


Condition
Childhood Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inform future sample stratification by over-sampling minority and rural-dwelling survivors to enhance the heterogeneity of the respondent pool. [ Time Frame: July 2011 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the sample selection methods, length of time to complete recruitment, and response rates in the study sample. [ Time Frame: July 2011 ] [ Designated as safety issue: No ]

Enrollment: 1178
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073735

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Cheryl Cox, RN, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01073735     History of Changes
Other Study ID Numbers: INSURE, R21CA142921
Study First Received: February 22, 2010
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Needs assessment
Health-related needs
Childhood cancer survivors

ClinicalTrials.gov processed this record on April 17, 2014