Clinical trial NCT01073735: Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience
Official title: Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cancer
Keywords: Needs assessment
Health-related needs
Childhood cancer survivors
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-02-23
Enrollment: 1178
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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

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 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.

Primary outcomes:
measure: 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.
timeFrame: July 2011
Secondary outcomes:
measure: Inform future sample stratification by over-sampling minority and rural-dwelling survivors to enhance the heterogeneity of the respondent pool.
timeFrame: July 2011
measure: Describe the met and unmet needs of childhood cancer survivors and their important covariates in a large, stratified random sample of childhood cancer survivors.
timeFrame: July 2011
measure: Evaluate the sample selection methods, length of time to complete recruitment, and response rates in the study sample.
timeFrame: July 2011
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Cheryl Cox, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: