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Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01073735
First Posted: February 23, 2010
Last Update Posted: February 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
  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

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 ]

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 ]
  • 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 ]
  • Evaluate the sample selection methods, length of time to complete recruitment, and response rates in the study sample. [ Time Frame: July 2011 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Cheryl Cox, RN, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01073735     History of Changes
Other Study ID Numbers: INSURE
R21CA142921 ( U.S. NIH Grant/Contract )
First Submitted: February 22, 2010
First Posted: February 23, 2010
Last Update Posted: February 9, 2012
Last Verified: February 2012

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