Form:RCT Study: Difference between revisions

Revision as of 07:03, 29 July 2024

This is the "RCT Study" form. To create a page with this form, enter the page name below; if a page with that name already exists, you will be sent to a form to edit that page.

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 Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease;
 No therapy setting: includes patients who completed cancer therapy, patients who are currently not in cancer treatment and cancer survivors|note}}
-| {{{field|Setting|input type=checkboxes|delimiter=,|default=?|mandatory|values=?, Neo-adjuvant, Adjuvant, Palliative, Active surveillance, No therapy setting, NI}}}
+| {{{field|Setting|input type=checkboxes|delimiter=,|default=?|mandatory|values=?, Curative, Neo-adjuvant, Adjuvant, Palliative, Active surveillance, No therapy setting, NI}}}
 |-
 ! Types of cancer: {{#info: "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included|note}}
-| {{{field|Types of cancer|input type=text with autocomplete|mandatory|default=?|delimiter=,|values=Adrenal Cancer,Anal Cancer,Bile Duct Cancer,Bone and Soft Tissue Cancers, Bone and Soft Tissue Cancers - Osteosarcoma,Bone and Soft Tissue Cancers - Ewing Sarcoma,Bone and Soft Tissue Cancers - Chondrosarcoma,Bone and Soft Tissue Cancers - Rhabdomyosarcoma,Bone and Soft Tissue Cancers – Liposarcoma,Brain and Central Nervous System (CNS) Cancers,Brain and Central Nervous System (CNS) Cancers - Astrocytoma,Brain and Central Nervous System (CNS) Cancers - Glioblastoma,Brain and Central Nervous System (CNS) Cancers - High-Grade Glioma,Brain and Central Nervous System (CNS) Cancers - Meningioma,Breast Cancer,Breast Cancer - Ductal Carcinoma,Breast Cancer - Lobular Carcinoma,Breast Cancer - Inflammatory Breast Cancer,Breast Cancer - Triple-Negative Breast Cancer,Carcinosarcoma,Colorectal Cancer,Colorectal Cancer - Colon Cancer,Colorectal Cancer - Rectal Cancer,Gastrointestinal Cancers,Gastrointestinal Cancers - Gastric (Stomach) Cancer,Gastrointestinal Cancers - Esophageal Cancer,Gastrointestinal Cancers - Pancreatic Cancer,Gastrointestinal Cancers - Liver Cancer,Genitourinary Cancers,Genitourinary Cancers - Bladder Cancer,Genitourinary Cancers - Kidney (Renal) Cancer,Genitourinary Cancers - Testicular Cancer,Genitourinary Cancers - Urethral Cancer,Gynecologic Cancers,Gynecologic Cancers - Ovarian Cancer,Gynecologic Cancers - Cervical Cancer,Gynecologic Cancers - Uterine Cancer,Gynecologic Cancers - Endometrial Cancer,Gynecologic Cancers - Vulvar Cancer,Head and Neck Cancers, Head and Neck Cancers - Oral Cancer,Head and Neck Cancers - Oropharyngeal Cancer,Head and Neck Cancers - Laryngeal Cancer,Head and Neck Cancers - Nasopharyngeal Cancer,Head and Neck Cancers - Tongue Cancer,Head and Neck Cancers - Thyroid Cancer,Head and Neck Cancers - Ethmoid Sinus Cancer,Hematologic Cancers, Hematologic Cancers - Leukemia (Acute Lymphocytic/Acute Myeloid/Chronic Lymphocytic/Chronic Myeloid), Hematologic Cancers - Lymphoma (Hodgkin and Non-Hodgkin),Hematologic Cancers - Multiple Myeloma,Lung Cancer,Lung Cancer - Small Cell Lung Cancer,Lung Cancer - Non-Small Cell Lung Cancer,Neuroblastoma,Prostate Cancer,Retinoblastoma,Skin Cancer,Skin Cancer - Basal Cell Carcinoma,Skin Cancer - Squamous Cell Carcinoma,Skin Cancer – Melanoma,Stomach Cancer,Solid Malignancies,Thymoma and Thymic Carcinoma,Unspecified Sarcoma,Other Cancers,NI,?}}}
+| {{{field|Types of cancer|input type=text with autocomplete|mandatory|default=?|delimiter=,|values=Adrenal Cancer,Anal Cancer,Bile Duct Cancer,Bone and Soft Tissue Cancers, Bone and Soft Tissue Cancers - Osteosarcoma,Bone and Soft Tissue Cancers - Ewing Sarcoma,Bone and Soft Tissue Cancers - Chondrosarcoma,Bone and Soft Tissue Cancers - Rhabdomyosarcoma,Bone and Soft Tissue Cancers – Liposarcoma,Brain and Central Nervous System (CNS) Cancers,Brain and Central Nervous System (CNS) Cancers - Astrocytoma,Brain and Central Nervous System (CNS) Cancers - Glioblastoma,Brain and Central Nervous System (CNS) Cancers - High-Grade Glioma,Brain and Central Nervous System (CNS) Cancers - Meningioma,Breast Cancer,Breast Cancer - Ductal Carcinoma,Breast Cancer - Lobular Carcinoma,Breast Cancer - Inflammatory Breast Cancer,Breast Cancer - Triple-Negative Breast Cancer,Carcinosarcoma,Colorectal Cancer,Colorectal Cancer - Colon Cancer,Colorectal Cancer - Rectal Cancer,Gastrointestinal Cancers,Gastrointestinal Cancers - Gastric (Stomach) Cancer,Gastrointestinal Cancers - Esophageal Cancer,Gastrointestinal Cancers - Pancreatic Cancer,Gastrointestinal Cancers - Liver Cancer,Genitourinary Cancers,Genitourinary Cancers - Bladder Cancer,Genitourinary Cancers - Kidney (Renal) Cancer,Genitourinary Cancers - Testicular Cancer,Genitourinary Cancers - Urethral Cancer,Gynecologic Cancers,Gynecologic Cancers - Ovarian Cancer,Gynecologic Cancers - Cervical Cancer,Gynecologic Cancers - Uterine Cancer,Gynecologic Cancers - Endometrial Cancer,Gynecologic Cancers - Vulvar Cancer,Head and Neck Cancers, Head and Neck Cancers - Oral Cancer,Head and Neck Cancers - Oropharyngeal Cancer,Head and Neck Cancers - Laryngeal Cancer,Head and Neck Cancers - Nasopharyngeal Cancer,Head and Neck Cancers - Tongue Cancer,Head and Neck Cancers - Thyroid Cancer,Head and Neck Cancers - Ethmoid Sinus Cancer,Hematologic Cancers, Hematologic Cancers - Leukemia (Acute Lymphocytic/Acute Myeloid/Chronic Lymphocytic/Chronic Myeloid), Hematologic Cancers - Lymphoma (Hodgkin and Non-Hodgkin),Hematologic Cancers - Multiple Myeloma,Lung Cancer,Lung Cancer - Small Cell Lung Cancer,Lung Cancer - Non-Small Cell Lung Cancer,Mesothelioma,Neuroblastoma,Prostate Cancer,Retinoblastoma,Skin Cancer,Skin Cancer - Basal Cell Carcinoma,Skin Cancer - Squamous Cell Carcinoma,Skin Cancer – Melanoma,Stomach Cancer,Solid Malignancies,Thymoma and Thymic Carcinoma,Unspecified Sarcoma,Other Cancers,NI,?}}}
 |-
 ! Cancer stage: {{#info: Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;
@@ Line 173: / Line 173: @@
 '''Outcome type:''' {{#info: As specificed by the authors| note}} {{{field|Outcome type|input type=radiobutton|mandatory|default=?|values=?,Primary,Secondary,Others,NI}}}
-'''Outcome name:''' {{{field|Outcome name|input type=text with autocomplete|mandatory|default=?|delimiter=,|values=Anorexia/Cachexia,Antibodies, Anxiety,Appetite,BMD (Bone Mineral Density),Body composition,Carnitine level,Carotenoid concentration,Cerebral oedema,CINV (Chemotherapy-Induced Nausea and Vomiting),Cognitive functioning,Cognitive impairment,Depression,Dermatitis,DFS (Disease-Free Survival),Diarrhoe,Distress,Duration of fever,Dysgeusia,EFS (Event-Free Survival),Ejection fraction,Emesis,Erectile dysfunction,Esophagitis,Fatigue,Fibrosis,Folic acid level,Functionality,Haematological indices,Haematological toxicity,Hand-foot syndrome,Hand grip strength,Hepatotoxicity,Hot flushes,Hormone level,Ileus (intestinal obstruction),Incidence of acute GVHD (Graft-Versus-Host Disease),Length of hospital stay,LFS (Local-Free Survival),Lymphedema,Menopausal symptoms,MFS (Metastases-Free Survival),Mood/Affect,Mortality rate,MTD (Maximum Tolerated Dose),Mucositis,Musculoskeletal symptoms,Nausea,Nausea and Vomiting,Neutropenia,Non-haematological indices,Nutrition status,Objective signs and subjective symptoms,OS (Overall Survival),Ototoxicity,Pain,PD (Pharmacodynamics),Performance Status,Peripheral neuropathy,PFS (Progression-Free Survival),Pharyngitis,PK (Pharmacokinetics),PSADT (Prostate-Specific Antigen Doubling Time),PSA level (Prostate-Specific Antigen),Quality of life,Recurrence rate,Reduction of complication rates,Relaxation,Restoration of bowel function after surgery,RFS (Recurrence-Free Survival),Salivary gland function,Selenium level,Seroconversion,Shoulder mobility,Side effects of androgen deprivation/suppression,Skeletal morbidity-free survival,Sleep,Stress,Taste alteration,Tea polyphenol uptake,Thromboembolic event rates,Toxicity,Tumor progression,Tumor response,Vaginal atrophy,Vitamin A level,Vitamin B6 level,Vitamin B12 level,Vitamin B17 level,Vitamin C level,Vitamin D level,Vitamin E level,Vomiting,Weight,Well-being,Wound healing,Wound odour,Xerostomia,Zinc level,Unspecified effects,NI,?}}}
+'''Outcome name:''' {{{field|Outcome name|input type=text with autocomplete|mandatory|default=?|delimiter=,|values=Anorexia/Cachexia,Antibodies, Anxiety,Appetite,Arterial inflow,BMD (Bone Mineral Density),Body composition,Carnitine level,Carotenoid concentration,Cerebral oedema,CINV (Chemotherapy-Induced Nausea and Vomiting),Cognitive functioning,Cognitive impairment,Depression,Dermatitis,DFS (Disease-Free Survival),Diarrhoe,Distress,Duration of fever,Dysgeusia,EFS (Event-Free Survival),Ejection fraction,Emesis,Erectile dysfunction,Erythema,Esophagitis,Fatigue,Fibrosis,Folic acid level,Frequency of rescue analgesics,Functional status,Functionality,Haematological indices,Haematological toxicity,Hand-foot syndrome,Hand grip strength,Hepatotoxicity,Hot flushes,Hormone level,Ileus (intestinal obstruction),Incidence of acute GVHD (Graft-Versus-Host Disease),Laboratory parameters,Length of hospital stay,LFS (Local-Free Survival),Lymphedema,Menopausal symptoms,Mental status/ function,MFS (Metastases-Free Survival),Mood/Affect,Mortality rate,MTD (Maximum Tolerated Dose),Mucositis,Musculoskeletal symptoms,Nausea,Nausea and Vomiting,Neurotoxicity,Neutropenia,Non-haematological indices,Nutrition status,Objective signs and subjective symptoms,Oral ulcus,OS (Overall Survival),Ototoxicity,Pain,PD (Pharmacodynamics),Performance Status,Peripheral neuropathy,PFS (Progression-Free Survival),Pharyngitis,Physical functioning,PK (Pharmacokinetics),Postoperative opiate consumption,PSADT (Prostate-Specific Antigen Doubling Time),PSA level (Prostate-Specific Antigen),Quality of life,Recurrence rate,Reduction of complication rates,Relaxation,Restoration of bowel function after surgery,RFS (Recurrence-Free Survival),Salivary gland function,Selenium level,Seroconversion,Shoulder mobility,Side effects of androgen deprivation/suppression,Skeletal morbidity-free survival,Sleep,Stress,Taste alteration,Tea polyphenol uptake,Thromboembolic event rates,Toxicity,Tumor progression,Tumor response,Vaginal atrophy,Vitamin A level,Vitamin B6 level,Vitamin B12 level,Vitamin B17 level,Vitamin C level,Vitamin D level,Vitamin E level,Vomiting,Weight,Well-being,Wound healing,Wound odour,Xerostomia,Zinc level,Unspecified effects,NI,?}}}
 '''Outcome specification:''' {{{field|Outcome specification|input type=textarea|default=?}}}
-'''Type of measurement:''' {{{field|Type of measurement|input type=tokens|mandatory|default=?|delimiter=,|values=AQoL-8D (Assessment of Quality of Life),ASAT (Auditory Sustained Attention Test),Atomic absorption,Audiogram,AUSCAN (Australian/Canadian Osteoarthritis Hand Index),BCPT (Breast Cancer Prevention Symptom Scales),BFI (Brief Fatigue Inventory),BIA (Bioelectrical impedance analysis),Blood Test,BPI-SF (Brief Pain Inventory - Short Form),Chemiluminescent immunoassay,CTCAE (Common Terminology Criteria of Adverse Events),Cystoscopy,Diary questionnaire,DXA (Dual energy X-ray Absorptiometry),Dynamometer,ECOG Performance Status Scale (Eastern Cooperative Oncology Group),Electrophysiological evaluation,ELISA protocol (Enzyme-Linked Immunoabsorbent Assay),EORTC QLQ (European Organisation for Research and Treatment of Cancer Core/ Quality of Life questionnaire),ESAS (Edmonton Symptom Assessment Scale),FAACT (Functional Assessment of Anorexia-Cachexia Therapy),FACIT (Functional Assessment of Chronic Illness Therapy),FACT (Functional Assessment of Cancer Therapy),FGS (Hughes' Functional Grading Scale),FIQ (Fibromyalgia Impact Questionnaire),FLIE (Functional Living Index for Emesis),Genitourinary atrophy self-assessment tool,GFAAS (Graphite Furnace Atomic Absorption Spectrometry),HADS (Hospital Anxiety and Depression Scale),HAQ-DI (Health Assessment Questionnaire-Disability Index),HFRDIS (Hot Flash Related Daily Interference Scale),HFS (Hot Flush Score),HGST Maximum (Handgrip Strength Test),Histological examination,HNQR (Head and Neck Radiotherapy Questionnaire),HSCS (High Sensitivity Cognitive Screen),LASA (Linear Analogue Self-Assessment),LENT SOMA Scale (Late Effects on Normal Tissues/ Subjective Objective Management Analysis),MADRS (Montgomery-Asberg Depression Rating Scale),MAT (Multinational Association of Supportive Care in Cancer-Antiemesis Tool),McDonald criteria,MENQOL (Menopause-Specific Quality of Life),MFI-20 (Multidimensional Fatigue Inventory-20),MOS SF-12 (Medical Outcomes Study/ 12-Item Short Form Health Survey),MRI (Magnetic Resonance Imaging),NCI-CTC v.2 (National Cancer Institute-Common Toxic Criteria),NCI Grading Scale (National Cancer Institute),NDS (Neurological Disability Score),Neurologic examination,Neuropathy specific question,NRS (Numeric Rating Scale),NRS (Nutritional Risk Screening),NSS (Neurological Symptom Score),Observation,OMAS (Oral Mucositis Assessment Scale),PHLF (Post Hepatectomy Liver Failure),PHS (Cognitive subscale of the Perceived Health Scale),pH-value,Physical functioning (grip strength;6 minute walk;leg extension),POMS (Profile of Mood States),Postoperative morbidity/complications (classification according to Clavien-Dindo),PROMIS (Patient-Reported Outcomes Measurement Information System),QoR-40 (Quality of Recovery-40 Questionnaire),RECIST 1.0 Criteria (Response Evaluation Criteria in Solid Tumors),Reidel-Seiffer tuning fork,RPSAS (Radiation Proctopathy System Assessment Scale),RTOG Acute Radiation Morbidity Scoring Criteria (Radiation Therapy Oncology Group),Scale,Scintigraphy,SF-36 (Short Form-36 Health Survey),SOMA (Subjective Objective Medical management and Analytic evaluation of injury),SPECT (Single Photon Emission Computed Tomography),Spectrophotometry,SPPB (Short Physical Performance Battery),Symptom experience diary,Three-stimulus drop technique (by Henkin),TMT (Trail Making Test),TNS (Total Neuropathy Score),Ultrasonography,Urinalysis,VAS (Visual Analogue Scale),VMI (Vaginal Maturation Index),VNS (Verbal Numerical Scale),Western Ontario and McMaster Osteoarthritis Index,WHO-Scale (World Health Organisation),Wound volume,Others,NI,?}}}
+'''Type of measurement:''' {{{field|Type of measurement|input type=tokens|mandatory|default=?|delimiter=,|values=AQoL-8D (Assessment of Quality of Life),ASAT (Auditory Sustained Attention Test),Atomic absorption,Audiogram,AUSCAN (Australian/Canadian Osteoarthritis Hand Index),BCPT (Breast Cancer Prevention Symptom Scales),BFI (Brief Fatigue Inventory),BIA (Bioelectrical impedance analysis),Blood Test,BPI-SF (Brief Pain Inventory - Short Form),CES-D (Center for Epidemiologic Studies - Depression Scale),Chemiluminescent immunoassay,CTCAE (Common Terminology Criteria of Adverse Events),Cystoscopy,Diary questionnaire,DXA (Dual energy X-ray Absorptiometry),Dynamometer,Echo-color Doppler,ECOG Performance Status Scale (Eastern Cooperative Oncology Group),Electrophysiological evaluation,ELISA protocol (Enzyme-Linked Immunoabsorbent Assay),EORTC QLQ (European Organisation for Research and Treatment of Cancer Core/ Quality of Life questionnaire),ESAS (Edmonton Symptom Assessment Scale),FAACT (Functional Assessment of Anorexia-Cachexia Therapy),FACIT (Functional Assessment of Chronic Illness Therapy),FACT (Functional Assessment of Cancer Therapy),FGS (Hughes' Functional Grading Scale),FIQ (Fibromyalgia Impact Questionnaire),FLIE (Functional Living Index for Emesis),Genitourinary atrophy self-assessment tool,GFAAS (Graphite Furnace Atomic Absorption Spectrometry),Global Charter Fatigue Scale,HADS (Hospital Anxiety and Depression Scale),HAQ-DI (Health Assessment Questionnaire-Disability Index),HFRDIS (Hot Flash Related Daily Interference Scale),HFS (Hot Flush Score),HGST Maximum (Handgrip Strength Test),Histological examination,HNQR (Head and Neck Radiotherapy Questionnaire),HSCS (High Sensitivity Cognitive Screen),ICI Test (Intracavernosal Injection Test),IIEF (International Index of Erectile Function),Interview,KPS (Karnofsky Performance Status),LASA (Linear Analogue Self-Assessment),LENT SOMA Scale (Late Effects on Normal Tissues/ Subjective Objective Management Analysis),MADRS (Montgomery-Asberg Depression Rating Scale),MAT (Multinational Association of Supportive Care in Cancer-Antiemesis Tool),McDonald criteria,MENQOL (Menopause-Specific Quality of Life),MFI-20 (Multidimensional Fatigue Inventory-20),MMSE (Mini-Mental State Exam),MOS SF-12 (Medical Outcomes Study/ 12-Item Short Form Health Survey),MPQ-SF (McGill Pain Questionnaire - Short Form),MRI (Magnetic Resonance Imaging),NCI-CTC v.2 (National Cancer Institute-Common Toxic Criteria),NCI Grading Scale (National Cancer Institute),NDS (Neurological Disability Score),Neurologic examination,Neuropathy specific question,NRS (Numeric Rating Scale),NRS (Nutritional Risk Screening),NSS (Neurological Symptom Score),Observation,OMAS (Oral Mucositis Assessment Scale),Otoacoustic Emissions Testing,PHLF (Post Hepatectomy Liver Failure),PHS (Cognitive subscale of the Perceived Health Scale),pH-value,Physical functioning (grip strength;6 minute walk;leg extension),POMS (Profile of Mood States),Postoperative morbidity/complications (classification according to Clavien-Dindo),PROMIS (Patient-Reported Outcomes Measurement Information System),PSQI (Pittsburgh Sleep Quality Index),QoR-40 (Quality of Recovery-40 Questionnaire),RDS (Radiation Dermatitis Severity),RECIST 1.0 Criteria (Response Evaluation Criteria in Solid Tumors),Reidel-Seiffer tuning fork,RPSAS (Radiation Proctopathy System Assessment Scale),RTOG Acute Radiation Morbidity Scoring Criteria (Radiation Therapy Oncology Group),Scale,Scintigraphy,SF-36 (Short Form-36 Health Survey),SI (Symptom Inventory questionnaire),SOMA (Subjective Objective Medical management and Analytic evaluation of injury),SPECT (Single Photon Emission Computed Tomography),Spectrophotometry,SPPB (Short Physical Performance Battery),Symptom experience diary (NCCTG),Three-stimulus drop technique (by Henkin),TMT (Trail Making Test),TNS (Total Neuropathy Score),Ultrasonography,Urinalysis,VAS (Visual Analogue Scale),VMI (Vaginal Maturation Index),VNS (Verbal Numerical Scale),Western Ontario and McMaster Osteoarthritis Index,WHO-Scale (World Health Organisation),Wound volume,Others,NI,NA,?}}}
 '''Results during intervention:''' {{{field|Results during intervention|input type=textarea|mandatory|default=?}}}