Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341757
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Family Health Study Validation of a Family History of Cancer Questionnaire for Risk Factor Surveillance
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Family Health Study Validation of a Family History of Cancer Questionnaire for Risk Factor Surveillance
Status:
COMPLETED
Status Verified Date:
2011-07-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Family history of cancer is an important possible indicator of inherited cancer susceptibility which has helped identify individuals and families at high risk of inherited cancers in research studies and clinical practice While there are also various potential uses of family history of cancer data in cancer surveillance the completeness and accuracy of family history of cancer data collected from the general population is unclear In an effort to evaluate the feasibility of conducting a national surveillance study to determine the prevalence of family history of cancer in the US population the Risk Factor Monitoring and Methods Branch will undertake a pilot study entitled the Family Health Study that examines issues of data quality In this study a family history of cancer questionnaire FHCQ will be developed for surveillance purposes and administered to a random digit dial RDD sample of households in the state of Connecticut Positive and negative reports of common cancers in the respondents families will be validated against records of the Connecticut Tumor Registry CTR and other data sources
The objectives are to 1 assess the agreement between respondent reports of specific cancers in first and second degree relatives and medical record-based reports as measured by percent concordance 2 quantify the sensitivity specificity and predictive value of the FHCQ by cancer site 3 evaluate the possible predictors of reporting accuracy including cancer site year of diagnosis kinship relation of the relative to the respondent and the frequency and quality of their contact overall family cohesiveness respondents own history of cancer and demographic factors 4 describe the completeness and reliability of family structure data
Validation of selected relatives cancer status will be done through data linkage to the Connecticut Tumor Registry other selected cancer registries the National Death Index Medicare claims data bases state death certificate registries or by obtaining consent to review available medical records from physicians and health care facilities Self-reports of respondents cancer status will also be validated since this may be a predictor of ability to accurately report family history A pre-established tracing algorithm will be used to triage cancer reports into the medical records systems where true cancer status is most likely to be verified by the highest quality data Validated cancer outco
The objectives are to 1 assess the agreement between respondent reports of specific cancers in first and second degree relatives and medical record-based reports as measured by percent concordance 2 quantify the sensitivity specificity and predictive value of the FHCQ by cancer site 3 evaluate the possible predictors of reporting accuracy including cancer site year of diagnosis kinship relation of the relative to the respondent and the frequency and quality of their contact overall family cohesiveness respondents own history of cancer and demographic factors 4 describe the completeness and reliability of family structure data
Validation of selected relatives cancer status will be done through data linkage to the Connecticut Tumor Registry other selected cancer registries the National Death Index Medicare claims data bases state death certificate registries or by obtaining consent to review available medical records from physicians and health care facilities Self-reports of respondents cancer status will also be validated since this may be a predictor of ability to accurately report family history A pre-established tracing algorithm will be used to triage cancer reports into the medical records systems where true cancer status is most likely to be verified by the highest quality data Validated cancer outco
Detailed Description:
Family history of cancer is an important possible indicator of inherited cancer susceptibility which has helped identify individuals and families at high risk of inherited cancers in research studies and clinical practice While there are also various potential uses of family history of cancer data in cancer surveillance the completeness and accuracy of family history of cancer data collected from the general population is unclear In an effort to evaluate the feasibility of conducting a national surveillance study to determine the prevalence of family history of cancer in the US population the Risk Factor Monitoring and Methods Branch will undertake a pilot study entitled the Family Health Study that examines issues of data quality In this study a family history of cancer questionnaire FHCQ will be developed for surveillance purposes and administered to a random digit dial RDD sample of households in the state of Connecticut Positive and negative reports of common cancers in the respondents families will be validated against records of the Connecticut Tumor Registry CTR and other data sources
The objectives are to 1 assess the agreement between respondent reports of specific cancers in first and second degree relatives and medical record-based reports as measured by percent concordance 2 quantify the sensitivity specificity and predictive value of the FHCQ by cancer site 3 evaluate the possible predictors of reporting accuracy including cancer site year of diagnosis kinship relation of the relative to the respondent and the frequency and quality of their contact overall family cohesiveness respondents own history of cancer and demographic factors 4 describe the completeness and reliability of family structure data
Validation of selected relatives cancer status will be done through data linkage to the Connecticut Tumor Registry other selected cancer registries the National Death Index Medicare claims data bases state death certificate registries or by obtaining consent to review available medical records from physicians and health care facilities Self-reports of respondents cancer status will also be validated since this may be a predictor of ability to accurately report family history A pre-established tracing algorithm will be used to triage cancer reports into the medical records systems where true cancer status is most likely to be verified by the highest quality data Validated cancer outcomes will be assigned ICD-9 codes by a nosology team following a double-blinded protocol A certainty level will be assigned to each cancer outcome based on the type of confirming medical record with evidence of microscopic confirmation of malignancy considered the most certain Statistical analyses to determine FHCQ1 sensitivity specificity and predictive value will be performed accounting for level of certainty Predictors of cancer reporting accuracy will be examined using multivariate regression
The objectives are to 1 assess the agreement between respondent reports of specific cancers in first and second degree relatives and medical record-based reports as measured by percent concordance 2 quantify the sensitivity specificity and predictive value of the FHCQ by cancer site 3 evaluate the possible predictors of reporting accuracy including cancer site year of diagnosis kinship relation of the relative to the respondent and the frequency and quality of their contact overall family cohesiveness respondents own history of cancer and demographic factors 4 describe the completeness and reliability of family structure data
Validation of selected relatives cancer status will be done through data linkage to the Connecticut Tumor Registry other selected cancer registries the National Death Index Medicare claims data bases state death certificate registries or by obtaining consent to review available medical records from physicians and health care facilities Self-reports of respondents cancer status will also be validated since this may be a predictor of ability to accurately report family history A pre-established tracing algorithm will be used to triage cancer reports into the medical records systems where true cancer status is most likely to be verified by the highest quality data Validated cancer outcomes will be assigned ICD-9 codes by a nosology team following a double-blinded protocol A certainty level will be assigned to each cancer outcome based on the type of confirming medical record with evidence of microscopic confirmation of malignancy considered the most certain Statistical analyses to determine FHCQ1 sensitivity specificity and predictive value will be performed accounting for level of certainty Predictors of cancer reporting accuracy will be examined using multivariate regression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-C-N214 | None | None | None |