An observational study in Cancer Survivor, sponsored by Wake Forest University Health Sciences. Completed at 327 sites in 2 countries. Open to participants aged 25 Years to 34 Years. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Wake Forest University Health Sciences · Observational
To document levels of labor force participation, occupation, educational attainment, and financial toxicity following cancer treatment in YA cancer survivors aged 25-34 years.
This observational, cross-sectional study will recruit 220 analyzable YA survivors through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base (WF NCORP RB). Data will be collected using a web-based interface and will capture physical, psychosocial and cognitive late effects; work ability; work-related outcomes, including labor force participation, occupation, work place characteristics, and educational attainment; survivor characteristics; and cancer diagnosis/treatment information (from clinical records). We will evaluate the relationships among these measures using the theoretical framework to guide statistical analysis.
Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Community Sample
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants complete a Current Medical Conditions Form, the CogState web-based cognitive assessment, and a Self-Report Questionnaire administration over 45-60 minutes containing measures of work ability and other work-related measures, cognitive, physical, and psychosocial symptoms, and characteristics of workplace environment. Self-report measures of individual and family characteristics, resources, and demands are also included.
Procedure: Cognitive Assessment · Other: Questionnaire Administration
Complete CogState
Complete Self-Report Questionnaire
Percentage of Participants Currently Employed
Labor force participation will be summarized as employed, unemployed (not working, but looking for work), and not in labor force (not employed and not looking for work or active duty military).
Time frame: Baseline
Occupation Status
This categorical work-related outcomes will be described using frequencies. Occupational status will be summarized using the 2010 Standard Occupational Classification (SOC) system: managerial and professional) (SOC major groups 11-29), (support, retail, and service (SOC major groups 31-43), and construction, production and transportation (SOC major groups 45-53).
Time frame: Baseline
Educational Attainment
This categorical work-related outcomes will be described using frequencies. Educational attainment will be classified as using the Current Population Survey classifications so that we can compare rates to US Benchmarks. The classifications are the following: Less than 1st grade, 1-4th grade, 5th-6th grade, 7-8th grade, 9th grade, 10th grade, 11th grade, 12 grade (no diploma), high school diploma or equivalent, some college (no degree), associate degree in college - occupational/vocational program, associate degree in college - academic program, Bachelor's degree, Master's degree, Professional School Degree (MD, DDS, DVM, JD etc.), Doctorate Degree.
Time frame: Baseline
Financial Toxicity
The Comprehensive Score for Financial Toxicity (COST) is a self-report measure of financial distress experienced in response to cancer and its treatment. It ranges from 0-44, with higher scores associated with greater financial toxicity.
Time frame: Baseline
Work ability (measured by Work Ability Index global score)
The Work Ability Index score ranges from 7 to 49, with higher scores indicating better workability; the Work Ability Index (WAI) global score is an item within the Work Ability Index which measures work ability from 0 to 10, with 10 representing the best work ability.
Time frame: Baseline
Work ability (measured by Work Ability Index)
The Work Ability Index (WAI) score ranges from 7 to 49, with higher scores indicating better workability; the Work Ability Index (WAI) global score is an item within the Work Ability Index which measures work ability from 0 to 10, with 10 representing the best work ability.
Time frame: Baseline
Work ability measured by Work Limitations Questionnaire score
The Work Limitations Questionnaire (WLQ) is a self-report measure of impact of chronic health conditions/treatment on job performance. Subscales: (1) time demands; (2) physical demands; (3) mental-interpersonal demands; and (4) output demands. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time) with 0 being better.
Time frame: Baseline
Showing the first 100 of 327 sites across 2 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Time frame: 6 months after publication for a 2 year duration.
Access criteria: upon request to NCORP@wakehealth.edu
Ran from Mar 2018 to primary completion in Apr 2022, 49 months.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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