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Eligibility Depression NCT00536172

- 02/03/2017 - 1 Formulaire, 2 Groupes Item, 13 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

Evaluating the Effectiveness of Escitalopram to Prevent Depression in Head and Neck Cancer Patients Receiving Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00536172

Eligibility Depression NCT00069927

- 18/08/2016 - 1 Formulaire, 2 Groupes Item, 14 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00069927

Eligibility Depression NCT00313573

- 22/04/2017 - 1 Formulaire, 1 Groupe Item, 20 Eléments de données, 1 Langue

Groupe Item: Criteria

Telemedicine or Standard Care in Treating Patients With Depression and/or Pain Caused By Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00313573

Eligibility Breast Cancer NCT01256008

- 31/08/2019 - 1 Formulaire, 2 Groupes Item, 18 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

Intervention Study of Depression in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01256008

Eligibility Head and Neck Cancer NCT02442739

- 02/04/2019 - 1 Formulaire, 2 Groupes Item, 22 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

Safety Study of Ketamine for Preventing Depression in Patients Undergoing Treatment for Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02442739

Measurement Instrument Database for the Social Science (MIDSS) - The Brief Edinburgh Depression Scale (BEDS)

- 30/09/2020 - 1 Formulaire, 2 Groupes Item, 7 Eléments de données, 1 Langue

Groupes Item: General Information, BRIEF EDINBURGH DEPRESSION SCALE

Lloyd-Williams, M., Shiels, C., Dowrick, C. (2006). The Brief Edinburgh Depression Scale (BEDS). Measurement Instrument Database for the Social Science. Retrieved 30.09.2020, from www.midss.ie Key references: Lloyd-Williams, M., Shiels, C., Dowrick, C. (2007). The development of the Brief Edinburgh Depression Scale (BEDS) to screen for depression in patients with advanced cancer. Journal of Affective Disorders, 99(1-3), 259-264. Primary use / Purpose: The Brief Edinburgh Depression Scale (BEDS) is a 6-item inventory rated on a 4 point Likert-type scale. Its purpose is to briefly and accurately measure depression in those in the advanced stages of cancer. Background: Depression and reduced quality of life have long been recognized as serious problems in the later stages of cancer. These mood states are commonly infered from physical symptoms such as weight loss, loss of appetite, or/and sleep disturbance. However, subjective measures are often ignored. The Brief Edinburgh Depression Scale (BEDS) aims to address this limitation by instead ignoring somatic symptoms, focusing only on subjective feelings of worth and sadness et alia. In its brief form the BEDS also has the advantage of being quick and easy to use which is an important consideration when dealing with terminally ill patients. Psychometrics: The psychometric properties of the Brief Edinburgh Depression Scale (BEDS) are discussed in Lloyd-Williams, Shiels, & Dowrick (2007). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.328 Scoring: Score of 6/18 is indicative of depression Background: The development of a brief valid tool to screen for depression in patients with advanced cancer is important. This paper reports data on the psychometric properties of the Brief Edinburgh Depression Scale Method: Two hundred and forty six patients who fulfilled the inclusion criteria completed the 10 item EDS and Present State Examination. Results: Factor extraction revealed 6 items from the ten item EDS. The most valid cut-off for defining a case, using the PSE diagnosis as the “gold-standard”, was a score of 6 out of 18 on the Brief Edinburgh Depression Scale which gave a sensitivity of 72% and specificity of 83% with a PPV of 65.1% and NPV of 87.1%. Conclusions: The six item EDS is a brief and sensitive method of screening for depression in advanced cancer patients - this novel use of the Edinburgh depression scale may have a significant impact on the assessment and thus management of this distressing symptom

Colorectal Cancer NCT01167725 Quality of Life - USMCI 8214/Z6091: Center for Epidemiological Studies Depression Scale (CES-D) - 2895901v1.0 - USMCI 8214/Z6091: Center for Epidemiological Studies Depression Scale (CES-D)

- 09/01/2015 - 1 Formulaire, 2 Groupes Item, 25 Eléments de données, 1 Langue

Groupes Item: Header Module, Quality of life

USMCI 8214/Z6091: Center for Epidemiological Studies Depression Scale (CES-D) Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6B3EABF4-20BB-57C5-E040-BB89AD430C2F

Metastatic Colorectal Cancer Fluorouracil Leucovorin Irinotecan Oxaliplatin NCT00077233 CALGB 80203 - Quality of Life CES-D

- 14/07/2017 - 1 Formulaire, 2 Groupes Item, 17 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Center for Epidemiologic Studies Depression Scale

CALGB: CES-D (SHORT FORM) Colorectal Cancer NCT00077233 Quality of Life - CALGB: CES-D (SHORT FORM) - 2088990v3.0 Fluorouracil and Leucovorin Plus Either Irinotecan or Oxaliplatin With or Without Cetuximab in Treating Patients With Previously Untreated Metastatic Adenocarcinoma of the Colon or Rectum https://clinicaltrials.gov/ct2/show/NCT00077233

dbGaP phs000428 Health and Retirement Study (HRS) - pht005036.v1.p2

- 29/01/2025 - 6 Formulaires, 1 Groupe Item, 4 Eléments de données, 1 Langue

Groupe Item: pht005036

Principal Investigator: David Weir, PhD, University of Michigan, Ann Arbor, MI, USA MeSH: Aging,Neoplasms,Arthritis,Lung Diseases, Obstructive,Dementia,Heart Diseases,Heart Failure,Hypertension,Myocardial Infarction,Diabetes Mellitus,Hypercholesterolemia,Obesity,Body Weight,Mobility Limitation,Pain,Cholesterol,Hemoglobin A, Glycosylated,C-Reactive Protein,Cystatin C,Depression,Alcohol Drinking,Smoking,Personality,Life Style,Cognition,Demography,Ethnic Groups,Health Status,Population Groups,Housing,Independent Living,Socioeconomic Factors,Career Mobility,Educational Status,Employment,Family Characteristics,Income,Occupations,Poverty,Social Change,Social Class,Social Conditions,Risk Factors https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000428 *Introduction to V2: *This data release comprises data from the V1 release combined with approximately 3,000 additional samples, collected during the HRS 2010 field period. The 2010 data include samples from a random half of the new cohort enrolled in 2010 along with a significant expansion of the minority sample. *Description:* The University of Michigan Health and Retirement Study (HRS) is a longitudinal panel study that surveys a representative sample of approximately 20,000 people in America over the age of 50 every two years. Supported by the National Institute on Aging (NIA U01AG009740) and the Social Security Administration, the HRS explores the changes in labor force participation and the health transitions that individuals undergo toward the end of their work lives and in the years that follow. The study collects information about income, work, assets, pension plans, health insurance, disability, physical health and functioning, cognitive functioning, and health care expenditures. Through its unique and in-depth interviews, the HRS provides an invaluable and growing body of multidisciplinary data that researchers can use to address important questions about the challenges and opportunities of aging. Because of its innovation and importance, the HRS has become the model and hub for a growing network of harmonized longitudinal aging studies around the world. *Origins of the HRS.* As the population ages it is increasingly important to obtain reliable data about aging and topics that are relevant to a range of policy issues in aging. To address this need, the National Institutes on Aging (NIA) established a cooperative agreement with the University of Michigan Institute for Social Research to collect such data. The HRS launched data collection in 1992 and has re-interviewed the original sample of respondents every two years since then. By adding new cohorts and refreshing the sample, the HRS has grown to become the largest, most representative longitudinal panel study of Americans 50 years and older. *HRS Study Design.* The target population for the original HRS cohort includes all adults in the contiguous United States born during the years 1931-1941 who reside in households, with a 2:1 oversample of African-American and Hispanic populations. The original sample is refreshed with new birth cohorts (51-56 years of age) every six years. The sample has been expanded over the years to include a broader range of birth cohorts as well. The target population for the AHEAD survey consists of United States household residents who were born in 1923 or earlier. Children of the Depression (CODA) recruits households born 1924-1930, War Babies 1942-47, Early Boomers 1948-53, and Mid-Boomers 1954-59. Data collection includes a mixed mode design combining in-person, telephone, mail, and Internet. For consenting respondents, HRS data are linked at the individual level to administrative records from Social Security and Medicare claims. *Genetic Research in the HRS.* The HRS has genotyped 2.5 million single nucleotide polymorphisms (SNPs) on respondents using Illumina's Human Omni2.5-Quad (Omni2.5) BeadChip. The genotyping was performed by the NIH Center for Inherited Disease Research (CIDR). Saliva was collected on half of the HRS sample each wave starting in 2006. In 2006, saliva was collected using a mouthwash collection method. From 2008 onward, the data collection method switched to the Oragene kit. Saliva completion rates were 83% in 2006, 84% in 2008, and 80% in 2010 among new cohort enrollees. HRS Phenotypic data. Phenotypic data are available on a variety of dimensions. Health measures include physical/psychological self-report, various health conditions, disabilities, cognitive performance, health behaviors (smoking, drinking, exercise), physical performance and anthropomorphic measures, and biomarkers (HbA1c, Total Cholesterol, HDL, CRP, Cystatin-C). Data are also available on health services including utilization, insurance and out-of-pocket spending with linkage to Medicare records. Economic measures include employment status/history, earnings, disability, retirement, type of work, income by source, wealth by asset type, capital gains/debt, consumption, linkage to pensions, Social Security earnings/benefit histories. There is also extensive information on family structure, proximity, transfers to/from of money, time, social and psychological characteristics, as well as a wide range of demographics. Performance on a cognitive test combining immediate and delayed word recall was selected as an example trait for the dbGaP data release. In the immediate word recall task the interviewer reads a list of 10 nouns to the respondent and asks the respondent to recall as many words as possible from the list in any order. After approximately five minutes of asking other survey questions, the respondent is asked to recall the nouns previously presented as part of the immediate recall task. The total recall score is the sum of the correct answers to these two tasks, with a range of 0 to 20. Researchers who wish to link to other HRS measures not in dbGaP will be able to apply for access from HRS. A separate Data Use Agreement (DUA) will be required for linkage to the HRS data. See the HRS website (http://hrsonline.isr.umich.edu/gwas) for details.

Eligibility

1 Groupe Item 6 Eléments de données

pht002612.v2.p2

1 Groupe Item 4 Eléments de données

pht002613.v2.p2

1 Groupe Item 5 Eléments de données

pht002614.v2.p2

1 Groupe Item 7 Eléments de données

pht005037.v1.p2

1 Groupe Item 5 Eléments de données

Breast Cancer NCT00659373 Toxicity - Adverse Event Form (Form 24-AE) - 2072124v3.0 - Adverse Event Form (Form 24-AE)

- 09/01/2015 - 1 Formulaire, 9 Groupes Item, 57 Eléments de données, 1 Langue

Groupes Item: SEXUAL/REPRODUCTIVE FUNCTION, VASOMOTOR MENOPAUSAL, MUSCULOSKELETAL, PSYCHOLOGICAL, CARDIOVASCULAR/CEREBROVASCULAR, CONSTITUTIONAL SYMPTOMS, ALLERGIC REACTION / HYPERSENSITIVITY / INJECTION SITE REACTION, OTHER ADVERSE EVENTS, CCRR MODULE

Adverse Event Form (Form 24-AE) Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG-2402 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0FAA5C4-439E-0ACB-E034-0003BA12F5E7

Measurement Instrument Database for the Social Science (MIDSS) - Attitude Follow-Up Scale (AFS)

- 30/09/2020 - 1 Formulaire, 2 Groupes Item, 19 Eléments de données, 1 Langue

Groupes Item: Instructions, Extent

Stiggelbout, A. M., de Haes, J. C., Vree, R. van de Velde, C. J., Bruijninckx, C. M., van Groningen, K., Kievit, J. (1997). Attitude Follow-Up Scale (AFS). Measurement Instrument Database for the Social Science. Retrieved 30.09.2020, from www.midss.ie Key references: Stiggelbout, A. M., de Haes, J. C., Vree, R. van de Velde, C. J., Bruijninckx, C. M., van Groningen, K., and Kievit, J. (1997). Follow-up of colorectal cancer patients: quality of life and attitudes towards follow-up. Br J Cancer, 75(6), 914–920. Kiebert, G. M., Welvaart, K., Kievit, J. (1993). Psychological effects of routine follow up on cancer patients after surgery. Eur J Surg, 159(11–12), 601–607 Thewes, B., Butow, P., Zachariae, R., Christensen, S., Simard, S & Gotay, C. (2012). Fear of cancer recurrence: a systematic literature review of self-report measures. Psycho-Oncology, 21, 571–587 Primary use / Purpose: The Attitude Follow-Up Scale (AFS) is a 19-item inventory rated on a 4 point Likert-type scale. Its purpose is to measure the attitudes of cancer patients towards follow-up. Patients’ attitudes are measured under four dimensions: communication (with a physician), reassurance, nervous anticipation, and perceived disadvantages of the follow-up process. Background: A substantial amount of research exists on the well-being and quality of life associated with clinical samples, especially those diagnosed with cancer. However, little research has specifically studied the physical and psychological outcomes associated with follow-up procedures between patient and physician. To address this, Stiggelbout, de Haes, & Vree et al. (1997) tweaked an existing scale developed by Kiebert, Welvaart, Kievit (1993) and ended up with the Attitude Follow-Up Scale (AFS). Psychometrics: The psychometric properties of the Attitude Follow-Up Scale (AFS) are discussed in Stiggelbout, de Haes, & Vree et al. (1997). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.324

dbGaP phs000397 NIA Long Life Family Study (LLFS) - Eligibility

- 12/10/2022 - 6 Formulaires, 1 Groupe Item, 3 Eléments de données, 1 Langue

Groupe Item: IG.elig

Principal Investigator: Michael A. Province, PhD, Washington University School of Medicine, St. Louis, MO, USA MeSH: Longevity,Aging,Cardiovascular Diseases,Neoplasms,Stroke,Inflammation,Immune System,Diabetes Mellitus,Hypertension,Dyslipidemias,Lipids,Osteoporosis,Pulmonary Function Tests,Kidney Function Tests,Alzheimer Disease,Depression,Personality,Executive Function,Reproductive History https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000397 The Long Life Family Study (LLFS) is an international collaborative study of the genetics and familial components of exceptional survival, longevity, and healthy aging. Families were recruited through elderly probands (generally in their 90s) who self-reported on the survival history of their parents and siblings, and on the basis of this information, families which showed clustering of exceptional survival were recruited. [Specifically, a Family Longevity Selection Score (FLOSS) ≥7 was required. The FLOSS measures the average excess Observed lifespan over that Expected based upon lifetables, while adding a bonus term for still-living individuals. Thus FLOSS is a useful tool for scoring and selecting families for inclusion in a research study of exceptional survival (Sebastiani et al., 2009, PMID: 19910380)]. Probands resided in the catchment areas of four Field Centers (Boston University, Columbia University, University of Pittsburgh, and University of Southern Denmark). Recruited family members were phenotyped through extensive in-home visits by teams of technicians who traveled all over the USA and Denmark. Blood assays were centrally processed at a Laboratory Core (University of Minnesota) and protocols were standardized, monitored and coordinated through a Data Management Coordinating Center (Washington University). We examined and extensively phenotyped in all major domains of healthy aging, 4,953 individuals in 539 families through comprehensive in-home visits. Of these, 4,815 gave dbGaP sharing permission and had sufficient quantity/quality of DNA for GWAS genotyping. This large collection of families, selected on the basis of clustering for exceptional survival, is a unique resource for the study of human longevity and healthy aging. We estimate that less than 1% of the Framingham Heart Study (FHS) families (a roughly random population family sample) would meet the minimal entrance criteria for exceptional survival required in the LLFS (Sebastiani et al., 2009, PMID: 19910380). Thus, the least exceptional LLFS families show more clustering for exceptional longevity than 99% of the FHS families. Although the LLFS pedigrees were selected on the basis of longevity per se in the upper generation (and the generation above that), the children's generation have significantly lower rates of many major diseases and have better healthy aging profiles for many disease phenotypes (Newman et al., 2011, PMID: 21258136). The participants had their first in-person visit between 2006 and 2009. After that visit, they were contacted annually by telephone to update vital status, medical history, and general health. Between 2014 and 2017, willing participants completed a second in-person visit. The second visit followed the same protocols and centralized training as the first visit. During the second visit, a portable carotid ultrasound exam was added. Again, participants were continuously contacted annually for telephone follow-up during the period of the second in-person visit and after that. Annual telephone follow-ups currently ongoing, and plans for a third in-person visit are in progress.

pht002407.v3.p3

1 Groupe Item 4 Eléments de données

pht002408.v3.p3

1 Groupe Item 6 Eléments de données

pht002410.v3.p3

1 Groupe Item 106 Eléments de données

pht003356.v3.p3

1 Groupe Item 4 Eléments de données

pht002409.v3.p3

1 Groupe Item 3 Eléments de données

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