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Breast Cancer NCT00433589 Treatment - Endocrine therapy - 2498727v1.0 - Endocrine therapy

- 09.01.15 - 1 Formular, 3 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Header, Endocrine therapy, Footer Module
Endocrine therapy Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=19677A9A-FFBD-2E6F-E044-0003BA3F9857

ICHOM Lung Cancer - At time of treatment decision - Clinical Form

- 30.04.20 - 1 Formular, 2 Itemgruppen, 2 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Treatment Factors
ICHOM Lung cancer data collection Version 2.3.1 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Lung Cancer, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Small Cell and Non-Small Cell Lung Cancer Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy | Immunotherapy | Other This document contains At time of treatment decision - Clinical Form. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13). Both are free for all health care organizations, but a license is needed for use. http:// groups.eortc.be/qol/eortc-qlq-c30 is the official distribution site for EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires. Therefore only the total score will be included in this version of the standard set. Publication: Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852–860. doi:10.1183/13993003.02049-2015 For this standard set ICHOM was supported by the Alliance of Dedicated Cancer Centers. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Lung Cancer - Begin of treatment - Clinical Form

- 30.04.20 - 1 Formular, 2 Itemgruppen, 3 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Other
ICHOM Lung cancer data collection Version 2.3.1 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Lung Cancer, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Small Cell and Non-Small Cell Lung Cancer Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy | Immunotherapy | Other This document contains Begin of treatment - Clinical Form. Collecting Patient-Reported Outcome Measures: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire (EORTC QLQ-LC13). Both are free for all health care organizations, but a license is needed for use. http:// groups.eortc.be/qol/eortc-qlq-c30 is the official distribution site for EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires. Therefore only the total score will be included in this version of the standard set. Publication: Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852–860. doi:10.1183/13993003.02049-2015 For this standard set ICHOM was supported by the Alliance of Dedicated Cancer Centers. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Colorectal Cancer NCT00303628 - Treatment Summary Form Colorectal Cancer E5204 NCT00303628

- 23.03.15 - 1 Formular, 3 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: Header, Patient data, Therapy
E5204 Treatment Summary Form Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Had Surgery for Stage II or Stage III Rectal Cancer NCT00303628 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=089A3135-DAA8-2A7E-E044-0003BA3F9857

ICHOM Localized Prostate Cancer - Clinical Form annually after treatment initiation

- 20.09.21 - 1 Formular, 4 Itemgruppen, 52 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Treatment Variables, Acute Complications of Treatment, Survival and Disease Control
LOCALIZED PROSTATE CANCER DATA COLLECTION Version 2.0.5 Revised: April 7th , 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Localized prostate cancer Treatment Approaches: Active Surveillance | Watchful Waiting | Radical Prostatectomy* | External Beam Radiation Therapy* | Androgen Deprivation Therapy (ADT)* | Focal Therapy* | Other* * These should also be collected as salvage treatments where necessary This ODM-file contains a Clinical Form to be used annually after salvage treatment initiation. Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. TEST StudyFor example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. Survey used: Expanded Prostate Cancer Index Composite (EPIC-26): The EPIC-26 is free for all health care organizations, and a license is not needed. The scoring guide may be found at http://www.med.umich.edu/urology/research/EPIC/EPIC-26-Scoring-1.2007.pdf ; Wei J, Dunn R, Litwin M, Sandler H, and Sanda M. "Development and Validation of the Expanded Prostate Cancer Index Composite (EPIC) for Comprehensive Assessment of Health-Related Quality of Life in Men with Prostate Cancer", Urology. 56: 899-905, 2000. For registries choosing to implement the EPIC-CP rather than the EPIC-26, we recommend using the same variable IDs as the corresponding EPIC-26 questions. This means that only questions 2, 3, 4a, 4b, 4d, 4e, 5, 6e, 6b, 7, 8b, 9, 12, 13a, 13c, and 13d of the EPIC-26 are administered. Utilization of Sexual Medications/Devices: The Utilization of Sexual Medications/Devices is free for all health care organizations, and a license is not needed. Refer to http://dx.doi.org/10.1016/j.urology.2006.01.077 for more information European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ- PR25): The EORTC QLQ-PR25 is free for all health care organizations, but a license is needed for use. Therefore it will not be integrated in this Version of the questionnaire. For more information, please visit http://groups.eortc.be/qol/eortc-qlq-c30 . ICHOM was supported for the Localized Prostate Cancer Standard Set by the Movember Foundation. Publication: Martin NE, Massey L, Stowell C, et al. Defining a standard set of patient-centered outcomes for men with localized prostate cancer. Eur Urol. 2015;67(3):460‐467. doi:10.1016/j.eururo.2014.08.075 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Localized Prostate Cancer - Clinical Form within 6 months after treatment initiation

- 20.09.21 - 1 Formular, 3 Itemgruppen, 48 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Treatment Variables, Acute Complications of Treatment
LOCALIZED PROSTATE CANCER DATA COLLECTION Version 2.0.5 Revised: April 7th , 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions: Localized prostate cancer Treatment Approaches: Active Surveillance | Watchful Waiting | Radical Prostatectomy* | External Beam Radiation Therapy* | Androgen Deprivation Therapy (ADT)* | Focal Therapy* | Other* * These should also be collected as salvage treatments where necessary This ODM-file contains a Clinical Form to be used 6 months after primary treatment initiation. Surveys used: Expanded Prostate Cancer Index Composite (EPIC-26): The EPIC-26 is free for all health care organizations, and a license is not needed. The scoring guide may be found at http://www.med.umich.edu/urology/research/EPIC/EPIC-26-Scoring-1.2007.pdf ; Wei J, Dunn R, Litwin M, Sandler H, and Sanda M. "Development and Validation of the Expanded Prostate Cancer Index Composite (EPIC) for Comprehensive Assessment of Health-Related Quality of Life in Men with Prostate Cancer", Urology. 56: 899-905, 2000. For registries choosing to implement the EPIC-CP rather than the EPIC-26, we recommend using the same variable IDs as the corresponding EPIC-26 questions. This means that only questions 2, 3, 4a, 4b, 4d, 4e, 5, 6e, 6b, 7, 8b, 9, 12, 13a, 13c, and 13d of the EPIC-26 are administered. Utilization of Sexual Medications/Devices: The Utilization of Sexual Medications/Devices is free for all health care organizations, and a license is not needed. Refer to http://dx.doi.org/10.1016/j.urology.2006.01.077 for more information European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ- PR25): The EORTC QLQ-PR25 is free for all health care organizations, but a license is needed for use. Therefore it will not be integrated in this Version of the questionnaire. For more information, please visit http://groups.eortc.be/qol/eortc-qlq-c30 . ICHOM was supported for the Localized Prostate Cancer Standard Set by the Movember Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Swedish Bladder Cancer Registry - Treatment of Primary Tumor

- 15.11.17 - 1 Formular, 2 Itemgruppen, 30 Datenelemente, 2 Sprachen
Itemgruppen: General Information, Treatment of Primary Tumor
Swedish Bladder Cancer Registry Healthcare Quality http://www.cancercentrum.se/vast/cancerdiagnoser/urinvagar/urinblase--och-urinvagscancer/kvalitetsregister/dokument/ Treatment of Primary Tumor

Cervical Cancer Cisplatin NCT00064077 GOG - Treatment Completion Form

- 24.06.17 - 1 Formular, 3 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: HEADER MODULE, TREATMENT SCHEDULE, OFF-TREATMENT REASON
Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix GOG Treatment Completion Form 2059221v3.0 https://clinicaltrials.gov/ct2/show/NCT00064077

Cancer Treatments Protocol PhenX Toolkit

- 26.04.16 - 1 Formular, 1 Itemgruppe, 18 Datenelemente, 1 Sprache
Itemgruppe: PhenX - cancer treatment protocol
These questions start by asking if the respondent has had cancer. For respondents who have had cancer, detailed follow-up questions ask about the type of cancer treatment, including surgery, chemotherapy, radiation, and hormone therapy. ODM derived from: https://cde.nlm.nih.gov Primary source: https://www.phenxtoolkit.org/ Recent publication: Hendershot, T., Pan, H., Haines, J., Harlan, W.R., Marazita, M.L., McCarty, C.A., Ramos, E.M., and Hamilton, C.M. (2015) Using the PhenX toolkit to add standard measures to a study. Curr. Protoc. Hum. Genet. 86:1.21.1-1.21.17. doi: 10.1002/0471142905.hg0121s86 Permission to publish granted by Carol M. Hamilton.

Bladder Cancer CALGB 90104 NCT00014534 - Chemotherapy Dose Form Bladder Cancer (CALGB 90104)

- 25.07.15 - 1 Formular, 1 Itemgruppe, 26 Datenelemente, 1 Sprache
Itemgruppe: Chemotherapy Dose Form
CALGB: 90104 Chemotherapy Dose Form Combination Chemotherapy in Treating Patients With Bladder Cancer NCT00014534 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BE1C0B11-7B76-737C-E034-0003BA12F5E7

TREATMENT FORM Prostate Cancer (NCT00110214)

- 09.01.15 - 1 Formular, 2 Itemgruppen, 46 Datenelemente, 1 Sprache
Itemgruppen: Header, Clinical Data
CALGB: 90401 TREATMENT FORM Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy NCT00110214 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF49A3AB-7EC3-51E0-E034-0003BA3F9857

Treatment Form Breast Cancer (NCT00785291)

- 09.01.15 - 1 Formular, 8 Itemgruppen, 65 Datenelemente, 1 Sprache
Itemgruppen: Header, Bevacizumab/placebo, PACLITAXEL, NAB-PACLITAXEL, IXABEPILONE, BEVACIZUMAB, Prophylatic Myeloid Growth Factor, LABORATORY VALUES
CALGB-40502 Treatment Form Paclitaxel, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer NCT00785291 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=51FC385E-3E0F-0F32-E044-0003BA3F9857

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