Search results - Portal of Medical Data Models (MDM-Portal)

Itemgroups: Header, Treatment satisfaction, PHYSICAL WELL-BEING, Social and family well being, EMOTIONAL WELL-BEING, Functional Health, ADDITIONAL CONCERNS, Activity

NSABP Protocol C-09: Quality of Life Form Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer NCT00268463 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FC7E0FCB-064A-58CD-E034-0003BA3F9857

Eligibility NCT00932724 Metastatic Colorectal Cancer - Eligibility

- 3/15/21 - 1 form, 2 itemgroups, 25 items, 2 languages

Itemgroups: Inclusion Criteria, Exclusion Criteria

ODM derived from http://clinicaltrials.gov/show/NCT00932724

Eligibility Colorectal Cancer NCT01596582

- 10/7/20 - 1 form, 2 itemgroups, 8 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening; ODM derived from: https://clinicaltrials.gov/show/NCT01596582

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

- 9/30/20 - 1 form, 2 itemgroups, 19 items, 1 language

Itemgroups: 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

ICHOM Colorectal Cancer - Baseline Patient-reported Form

- 4/30/20 - 1 form, 3 itemgroups, 20 items, 1 language

Itemgroups: Administrative Data, Demographic Factors, Baseline Clinical Factors

COLORECTAL CANCER DATA COLLECTION Version 1.1.2 Revised: November 6th, 2017 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. Conditions: All patients with newly pathologically diagnosed invasive colorectal cancer (stage I-IV) Excluded Conditions: Non-adenocarcinoma, non-primary colorectal tumors and patients with recurrent disease at baseline will be excluded. Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy This ODM-file contains a Patient-reported Form to be administered at Baseline. In this standard set (parts of) the following questionnaires/scores are used: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Due to the need for a license, the EORTC QLQ-C30 questions are not included in this version of the standard set. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C29): Due to the need for a license, the EORTC QLQ-C29 questions are not included in this version of the standard set. Memorial Sloan-Kettering Cancer Center (MSKCC) Bowel Function Instrument: Only 4 of the items used. According to ICHOM it is free to use for all health care organizations and no license is needed. Temple, L., Bacik, J., Savatta, S. et al. The Development of a Validated Instrument to Evaluate Bowel Function After Sphincter-Preserving Surgery for Rectal Cancer. Dis Colon Rectum (2005) 48: 1353. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-LMC21): A license is needed for use of this questionnaire as well, however only one question is used. ICHOM was supported by Alliance of Dedicated Cancer Centers (CZ, DICA, Bowel Cancer Australia) for this standard set. Publication: Zerillo JA, Schouwenburg MG, van Bommel ACM, et al. An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer. JAMA Oncol. 2017;3(5):686–694. doi:10.1001/jamaoncol.2017.0417 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Colorectal Cancer - Baseline Clinical Form

- 4/30/20 - 1 form, 3 itemgroups, 33 items, 1 language

Itemgroups: Administrative Data, Baseline Clinical Factors, Baseline Treatment Factors

COLORECTAL CANCER DATA COLLECTION Version 1.1.2 Revised: November 6th, 2017 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. Conditions: All patients with newly pathologically diagnosed invasive colorectal cancer (stage I-IV) Excluded Conditions: Non-adenocarcinoma, non-primary colorectal tumors and patients with recurrent disease at baseline will be excluded. Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy In this standard set (parts of) the following questionnaires/scores are used: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Due to the need for a license, the EORTC QLQ-C30 questions are not included in this version of the standard set. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C29): Due to the need for a license, the EORTC QLQ-C29 questions are not included in this version of the standard set. Memorial Sloan-Kettering Cancer Center (MSKCC) Bowel Function Instrument: Only 4 of the items used. According to ICHOM it is free to use for all health care organizations and no license is needed. Temple, L., Bacik, J., Savatta, S. et al. The Development of a Validated Instrument to Evaluate Bowel Function After Sphincter-Preserving Surgery for Rectal Cancer. Dis Colon Rectum (2005) 48: 1353. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-LMC21): A license is needed for use of this questionnaire as well, however only one question is used. ICHOM was supported by Alliance of Dedicated Cancer Centers (CZ, DICA, Bowel Cancer Australia) for this standard set. Publication: Zerillo JA, Schouwenburg MG, van Bommel ACM, et al. An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer. JAMA Oncol. 2017;3(5):686–694. doi:10.1001/jamaoncol.2017.0417 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Colorectal Cancer - 6 months post treatment Clinical Form

- 4/30/20 - 1 form, 4 itemgroups, 39 items, 1 language

Itemgroups: Administrative Data, Treatment variables, Survival and disease control, Disutility of care

COLORECTAL CANCER DATA COLLECTION Version 1.1.2 Revised: November 6th, 2017 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. Conditions: All patients with newly pathologically diagnosed invasive colorectal cancer (stage I-IV) Excluded Conditions: Non-adenocarcinoma, non-primary colorectal tumors and patients with recurrent disease at baseline will be excluded. Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy In this standard set (parts of) the following questionnaires/scores are used: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Due to the need for a license, the EORTC QLQ-C30 questions are not included in this version of the standard set. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C29): Due to the need for a license, the EORTC QLQ-C29 questions are not included in this version of the standard set. Memorial Sloan-Kettering Cancer Center (MSKCC) Bowel Function Instrument: Only 4 of the items used. According to ICHOM it is free to use for all health care organizations and no license is needed. Temple, L., Bacik, J., Savatta, S. et al. The Development of a Validated Instrument to Evaluate Bowel Function After Sphincter-Preserving Surgery for Rectal Cancer. Dis Colon Rectum (2005) 48: 1353. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-LMC21): A license is needed for use of this questionnaire as well, however only one question is used. ICHOM was supported by Alliance of Dedicated Cancer Centers (CZ, DICA, Bowel Cancer Australia) for this standard set. Publication: Zerillo JA, Schouwenburg MG, van Bommel ACM, et al. An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer. JAMA Oncol. 2017;3(5):686–694. doi:10.1001/jamaoncol.2017.0417 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Colorectal Cancer - Annual Clinical Form

- 4/30/20 - 1 form, 4 itemgroups, 33 items, 1 language

Itemgroups: Administrative Data, Survival and disease control, Treatment variables, Quality of death

ICHOM Colorectal Cancer - Patient-reported Form (Baseline, 6 months and annually post-treatment)

- 4/30/20 - 1 form, 2 itemgroups, 10 items, 1 language

Itemgroups: Administrative Data, Degree of health

COLORECTAL CANCER DATA COLLECTION Version 1.1.2 Revised: November 6th, 2017 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. Conditions: All patients with newly pathologically diagnosed invasive colorectal cancer (stage I-IV) Excluded Conditions: Non-adenocarcinoma, non-primary colorectal tumors and patients with recurrent disease at baseline will be excluded. Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy In this standard set (parts of) the following questionnaires/scores are used: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Due to the need for a license, the EORTC QLQ-C30 questions are not included in this version of the standard set. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C29): Due to the need for a license, the EORTC QLQ-C29 questions are not included in this version of the standard set. Memorial Sloan-Kettering Cancer Center (MSKCC) Bowel Function Instrument: Only 4 of the items used. According to ICHOM it is free to use for all health care organizations and no license is needed. Temple, L., Bacik, J., Savatta, S. et al. The Development of a Validated Instrument to Evaluate Bowel Function After Sphincter-Preserving Surgery for Rectal Cancer. Dis Colon Rectum (2005) 48: 1353. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-LMC21): A license is needed for use of this questionnaire as well, however only one question is used. ICHOM was supported by Alliance of Dedicated Cancer Centers (CZ, DICA, Bowel Cancer Australia) for this standard set. Publication: Zerillo JA, Schouwenburg MG, van Bommel ACM, et al. An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer. JAMA Oncol. 2017;3(5):686–694. doi:10.1001/jamaoncol.2017.0417 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Eligibility Incurable Colorectal Cancer NCT02071069

- 4/16/20 - 1 form, 2 itemgroups, 14 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02071069

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