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Work Ability in Young Adult Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03148080
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
To document levels of labor force participation, occupation, educational attainment, and financial toxicity following cancer treatment in YA cancer survivors aged 25-34 years.

Condition or disease Intervention/treatment
Cancer Survivor Procedure: Cognitive Assessment Other: Questionnaire Administration

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Work Ability in Young Adult Survivors (WAYS)
Actual Study Start Date : March 13, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational
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
Complete CogState

Other: Questionnaire Administration
Complete Self-Report Questionnaire




Primary Outcome Measures :
  1. Percentage of Participants Currently Employed [ Time Frame: Baseline ]
    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).

  2. Occupation Status [ Time Frame: Baseline ]
    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).

  3. Educational Attainment [ Time Frame: Baseline ]
    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.

  4. Financial Toxicity [ Time Frame: Baseline ]
    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.


Secondary Outcome Measures :
  1. Work ability (measured by Work Ability Index global score) [ Time Frame: Baseline ]
    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.

  2. Work ability (measured by Work Ability Index) [ Time Frame: Baseline ]
    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.

  3. Work ability measured by Work Limitations Questionnaire score [ Time Frame: Baseline ]
    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.



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Ages Eligible for Study:   25 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria

Inclusion Criteria:

  • >= 2 to < 10 years post-cancer diagnosis (per diagnostic pathology report)
  • Diagnosed with first cancer (any type except types listed in exclusion criteria below) at age >= 15 years
  • Ability to understand and willingness to sign a written informed consent document
  • Must be able to read and understand English

Exclusion Criteria:

  • Currently receiving active cancer treatment (acceptable to be on maintenance or hormonal therapies)
  • Life expectancy less than 6 months
  • Precancerous or pre invasive conditions (myelodysplastic syndrome; carcinoma in situ; non-melanoma skin cancer) without progression to malignancy without another prior primary cancer diagnosis; (those who have had these conditions may participate IF they have a primary cancer diagnosis)
  • Non-Hispanic Whites (effective 11/01/2018)

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): NCT03148080


Contacts
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Contact: Tammy Vogler, RN (336) 713-6907 NCORP@wakehealth.edu
Contact: Karen Craver, MT, MHA (336) 713-4394 NCORP@wakehealth.edu

  Show 271 Study Locations
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Suzanne Danhauer, PhD Wake Forest University Health Sciences

Additional Information:
Publications:
The President's Cancer Panel. Living Beyond Cancer: Finding New Balance, President's Cancer Panel 2003-2004 Annual Report. U.S. Department of Health and Human Services, National Institutes of Health.; 2004
Closing the Gap: A Strategic Plan Addressing the Recommendations of the Adolescent and Young Adult Oncology Progress Review Group. National Institutes of Health; 2007
LIVESTRONG Report Committee. "I Learned to Live with It" is Not Good Enough: Challenges Reported by Post-Treatment Cancer Survivors in the LIVESTRONG Surveys: A LIVESTRONG Report, 2010. Lance Armstrong Foundation; 2010. _http://livestrong.org/_. Accessed January 28, 2013
Behling O, Law KS. Translating Questionnaires and Other Research Insturments: Problems and Solutions. Sage paper series; 2000
WAI Online Questionnaire (Short Version) WAI Netzwerk. Bergische Universitat Wuppertal.; 2013
Tuomi K., Ilmarinen J, Katajarinne L, A. T. Work Ability Index. 2nd revised. Helsinki: Finnish Institute of Occupational Health, 1998; 1998
Smith TW, Marsden PV, Michael H, Jiburm K. General Social Surveys, 1972-2012: Cumulative Codebook / Principal Investigator, Tom W. Smith; Co-Principal Investigators, Peter V. Marsden and Michael Hout. 2nd revised. -- Chicago: National Opinion Research Center, 2013. 3,422 pp.,: National Data Program for the Social Sciences Series, no. 21; 2013.
Standard Occupational Classification Committee (SOCPC) 2010 SOC Definitions. U.S. Bureau of Labor Statistics. (Updated January 2013) 2010 SOC User Guide.U.S.Bureau of Labor Statistics _www.bls.gov/soc/soc_2010_definitions.pdf_; 2010
Gershon RC. Need for Cognitive Measures. In: National Institute on Disability and Rehabilitation. ; 2012.
Diener E, Wirtz D, Tov W, Kim-Prieto C, Choi D, Oishi S, Biswas-Diener R. New measures of well-being: Flourishing and positive and negative feelings. Soc Indic Res. 2010;39:247-266.
Baker F, Denniston M, Zabora JR, Marcellus D. Cancer Problems in Living and Quality of Life After Bone Marrow Transplation. J Clin Psychol Med Settings. 2003;10(1):27-34. doi:10.1023/A:1022801713046.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03148080     History of Changes
Other Study ID Numbers: IRB00045363
NCI-2017-00991 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
WF 10217 ( Other Identifier: Wake Forest NCORP Research Base )
WF-10217 ( Other Identifier: DCP )
WF-10217 ( Other Identifier: CTEP )
P30CA012197 ( U.S. NIH Grant/Contract )
R21CA191989 ( U.S. NIH Grant/Contract )
UG1CA189824 ( U.S. NIH Grant/Contract )
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No