Covid 19 Research using Clinical Trials (Home Page)
HP:0012288: Neoplasm of head and neckHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1197 | Group Exercise Classes Wiki | 0.50 |
| drug50 | 55 Gy Radiation Therapy Wiki | 0.50 |
| drug48 | 50 Gy Radiation Therapy Wiki | 0.50 |
| drug52 | 60 Gy Radiation Therapy Wiki | 0.50 |
| drug281 | Atezolizumab Wiki | 0.50 |
| drug2467 | Routine Oral Care and Analgesia Wiki | 0.50 |
| drug2572 | Screening test for covid ( RT PCR and CT Chest) Wiki | 0.50 |
| drug2107 | Photobiomodulation Wiki | 0.50 |
There are 4 clinical trials
Clinical Trials
1 Photobiomodulation Therapy Using the MuReva Phototherapy System to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Patients With Head and Neck Cancer Receiving Concurrent Radiation and Chemotherapy
The overall purpose of this clinical study is to evaluate safety and efficacy of the MuReva Phototherapy System with a light delivery mouthpiece to reduce the incidence of severe oral mucositis (OM) in adult patients with squamous cell carcinoma of the oral cavity, oropharynx, tonsils and base of tongue receiving concurrent radiation and chemotherapy.
NCT03972527 Oral Mucositis (Ulcerative) Oral Mucositis (Ulcerative) Due to Radiation Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy Head and Neck Cancer Device: Photobiomodulation Other: Routine Oral Care and Analgesia MeSH:Gingivitis, Necrotizing Ulcerative Head and Neck Neoplasms Mucositis Stomatitis Ulcer
HPO:Neoplasm of head and neck Stomatitis
Primary Outcomes
Description: The primary effectiveness endpoint of the study is the proportion of patients who have severe oral mucositis (Grade 3 or 4) at week 6 of treatment according to the World Health Organization (WHO) Oral Toxicity Scale.
Measure: Incidence of severe oral mucositis (WHO grade 3 and 4) at week 6 of chemoradiation therapy. Time: 6-8 weeks of photobiomodulation and chemoradiation therapy
Secondary Outcomes
Description: Radiation therapy oncology group scale (RTOG) 0 (Normal)- 4 (necrosis/hemorrhage), 5= death
Measure: Oral Mucositis (OM) Grade and Incidence, Time: 6-8 weeks, evaluated once per week
Description: World Health Organization scale (WHO) 0 (Normal)- 4 (oral alimentation not possible), 5= death
Measure: Oral Mucositis (OM) Grade and Incidence, Time: 6-8 weeks, evaluated once per week
Description: World Health Organization (WHO) analgesic ladder Steps 1-3: 1= non opioid, 2= weak opioid, 3= strong opioid
Measure: Analgesic Usage Time: 6-8 weeks, evaluated daily
2 Surgical Activity During the Covid-19 Pandemic: Results for 112 Patients in a French Tertiary Care Center: A Retrospective Observational Cohort Study
Primary Outcomes
Description: The primary effectiveness endpoint of the study is the proportion of patients who have severe oral mucositis (Grade 3 or 4) at week 6 of treatment according to the World Health Organization (WHO) Oral Toxicity Scale.
Measure: Incidence of severe oral mucositis (WHO grade 3 and 4) at week 6 of chemoradiation therapy. Time: 6-8 weeks of photobiomodulation and chemoradiation therapySecondary Outcomes
Description: Radiation therapy oncology group scale (RTOG) 0 (Normal)- 4 (necrosis/hemorrhage), 5= death
Measure: Oral Mucositis (OM) Grade and Incidence, Time: 6-8 weeks, evaluated once per weekDescription: World Health Organization scale (WHO) 0 (Normal)- 4 (oral alimentation not possible), 5= death
Measure: Oral Mucositis (OM) Grade and Incidence, Time: 6-8 weeks, evaluated once per weekDescription: World Health Organization (WHO) analgesic ladder Steps 1-3: 1= non opioid, 2= weak opioid, 3= strong opioid
Measure: Analgesic Usage Time: 6-8 weeks, evaluated dailyBackground After the emergence of Covid-19 in China, Hubei Province, the epidemic quickly spread to Europe. France was quickly hit and the Croix-Rousse hospital at the Hospices Civils de Lyon was one of the first French university hospital to receive patients infected with Sars-COV2. The predicted massive influx of patients motivated the cancellation of all elective surgical procedures planned to free hospitalization beds and to free intensive care beds. Nevertheless, patients who had to be canceled had to be properly selected to avoid a life threatening. The retained surgical indications were surgical emergencies, oncologic surgery and organ transplantation. The objective was to describe the organization of the Croix-Rousse hospital to allow the continuation of these surgical activities while limiting the exposure of patients to the Sars Cov2.
NCT04379232 Digestive Cancer Gynaecological Cancer Head and Neck Cancer Biological: Screening test for covid ( RT PCR and CT Chest) MeSH:Head and Neck Neoplasms
HPO:Neoplasm of head and neck
Primary Outcomes
Description: Patients are tested with RT PCR and CT Chest if they declare symptoms after surgery
Measure: Symptoms of Covid after surgery Time: Screening test are performed if the patient becomes symptomatic up to 14 days after surgery. In case of symptoms patients are tested within 24 hours.
3 A Phase I Trial of MR-Guided Dose-Escalated Hypofractionated Adaptive Radiation Therapy and Immunotherapy in Primary Metastatic or Very Locally Advanced Patients With Head and Neck Cancer
Primary Outcomes
Description: Patients are tested with RT PCR and CT Chest if they declare symptoms after surgery
Measure: Symptoms of Covid after surgery Time: Screening test are performed if the patient becomes symptomatic up to 14 days after surgery. In case of symptoms patients are tested within 24 hours.Locoregional failure remains the principal mode of mortality in head and neck squamous cell carcinoma (HNSCC) treated with conventional chemoradiation therapy. Magnetic resonance-guided radiation therapy (MRgRT) allows for adaptive radiation dose escalation based on tumor response and may improve therapeutic outcomes while limiting toxicities. This protocol evaluates a novel framework for radiation delivery with concurrent atezolizumab in patients with advanced HNSCC. Dose-Escalated Hypofractionated Adaptive Radiotherapy (DEHART) modifies radiation dose using MRgRT by escalating radiation dose to residual tumor while deescalating radiation dose to areas of tumor regression.
NCT04477759 Head and Neck Neoplasm Radiation: 50 Gy Radiation Therapy Radiation: 55 Gy Radiation Therapy Radiation: 60 Gy Radiation Therapy Drug: Atezolizumab MeSH:Head and Neck Neoplasms
HPO:Neoplasm of head and neck
Primary Outcomes
Description: This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.
Measure: Incidence of Dose-Limiting Toxicities Time: 12 months
Description: This measure is the highest radiation dose at which there is a 30% or more rate of dose-limiting toxicity up to 12 months after completion of radiation treatment using the TITE-CRM design.
Measure: Maximum Tolerated Radiation Dose Time: 12 months
Secondary Outcomes
Description: This measure is the number of subjects alive at 1 year following the conclusion of scheduled radiation therapy.
Measure: Overall Survival Time: 1 year
Description: This measure is the number of subjects showing disease progression in the head and neck by RECIST criteria.
Measure: Locoregional progression Time: 1 year
Description: This measure is the change in gross tumor volume for each subject as contoured on pre-treatment (baseline) and treatment 6 imaging scans.
Measure: Gross Tumor Volume at Radiation Fraction 6 (Change from Baseline) Time: 6th Radiation Fraction (approximately 1 week)
Description: This measure is the change in gross tumor volume for each subject as contoured on pre-treatment (baseline) and treatment 11 imaging scans.
Measure: Gross Tumor Volume at Radiation Fraction 11 (Change from Baseline) Time: 11th Radiation Fraction (approximately 2 weeks)
Description: MD Anderson Symptom Inventory for Head and Neck tool comprises 11-item Likert-style questions assessing 9 symptoms relevant to head and neck cancer. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck (MDASI-HN) Score Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "mucus in the mouth and throat" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to mucus in the mouth and throat. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Mucus in the Mouth and Throat) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "difficulty swallowing or chewing" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to swallowing or chewing. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Difficulty Swallowing or Chewing) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "choking or coughing" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to coughing or a sensation of choking. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Choking or Coughing) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "difficulty with voice or speech" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to voice production and quality or speech. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Difficulty with Voice or Speech) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "skin pain, burning or rash" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to the sensation of pain and/or burning and/or presence of a rash in irradiated areas of the skin. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Skin Pain, Burning or Rash) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "constipation" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to constipation and bowel function. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Constipation) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "problems with tasting food" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to the sensation of taste. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Problems with Tasting Food) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "mouth or throat sores" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to sores or lesions present in the mouth and throat. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Mouth or Throat Sores) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "problems with teeth or gums" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to oral health particularly the teeth and gums. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Problems with Teeth or Gums) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure comprises a single five-item, Likert-style question with responses ranging from 'Strongly Agree' to 'Strongly Disagree'. A higher score ('Strongly Agree') corresponds to a worse outcome.
Measure: MD Anderson Dysphagia Inventory Global Score Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure comprises 19 five-item, Likert-style questions with responses ranging from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') corresponds to worse traits or more severe symptoms.
Measure: MD Anderson Dysphagia Inventory Composite Score Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "emotional" domain comprising a subset of five-item, Likert-style questions of the MD Anderson Dysphagia Inventory Composite tool that assesses symptoms relevant to emotional health. Responses range from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') correspond to worse traits or more severe symptoms.
Measure: MD Anderson Dysphagia Inventory Score (Emotional) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "functional" domain comprising a subset of five-item, Likert-style questions of the MD Anderson Dysphagia Inventory Composite tool that assesses symptoms relevant to the ability to function in daily life activities. Responses range from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') correspond to worse traits or more severe symptoms.
Measure: MD Anderson Dysphagia Inventory Score (Functional) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: This measure is the score for the "physical" domain comprising a subset of five-item, Likert-style questions of the MD Anderson Dysphagia Inventory Composite tool that assesses symptoms relevant to the ability to perform physical activities. Responses range from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') correspond to worse traits or more severe symptoms.
Measure: MD Anderson Dysphagia Inventory Score (Physical) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1
Description: The Eating Assessment Tool comprises 10 five-item, Likert-style questions querying various aspects of swallowing. Responses range from 0 (No problem) to 4 (Severe problem). The total of the responses represents the EAT-10 score. Higher numbers indicate poorer swallowing ability.
Measure: Eating Assessment Tool (EAT-10) Score Time: Baseline, and months 3 and 6 following fraction 1
Description: The Functional Oral Intake Scale is a clinician-completed ordinal rating scale ranging from 1 (No oral intake) to 7 (Total oral intake with no restrictions). Higher numbers indicate more favorable feeding capability.
Measure: Functional Oral Intake Scale (FOIS) Time: Baseline, and months 3 and 6 following fraction 1
Description: The DIGEST grade is a five-item modified barium swallow scale for grading pharyngeal dysphagia as a toxicity endpoint. The DIGEST grade responses are: grade 1= mild, grade 2= moderate, grade 3= severe, and grade 4= life threatening pharyngeal dysphagia.
Measure: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Grade Time: Baseline, and months 3 and 6 following fraction 1
4 Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life
Primary Outcomes
Description: This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.
Measure: Incidence of Dose-Limiting Toxicities Time: 12 monthsDescription: This measure is the highest radiation dose at which there is a 30% or more rate of dose-limiting toxicity up to 12 months after completion of radiation treatment using the TITE-CRM design.
Measure: Maximum Tolerated Radiation Dose Time: 12 monthsSecondary Outcomes
Description: This measure is the number of subjects alive at 1 year following the conclusion of scheduled radiation therapy.
Measure: Overall Survival Time: 1 yearDescription: This measure is the number of subjects showing disease progression in the head and neck by RECIST criteria.
Measure: Locoregional progression Time: 1 yearDescription: This measure is the change in gross tumor volume for each subject as contoured on pre-treatment (baseline) and treatment 6 imaging scans.
Measure: Gross Tumor Volume at Radiation Fraction 6 (Change from Baseline) Time: 6th Radiation Fraction (approximately 1 week)Description: This measure is the change in gross tumor volume for each subject as contoured on pre-treatment (baseline) and treatment 11 imaging scans.
Measure: Gross Tumor Volume at Radiation Fraction 11 (Change from Baseline) Time: 11th Radiation Fraction (approximately 2 weeks)Description: MD Anderson Symptom Inventory for Head and Neck tool comprises 11-item Likert-style questions assessing 9 symptoms relevant to head and neck cancer. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck (MDASI-HN) Score Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "mucus in the mouth and throat" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to mucus in the mouth and throat. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Mucus in the Mouth and Throat) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "difficulty swallowing or chewing" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to swallowing or chewing. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Difficulty Swallowing or Chewing) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "choking or coughing" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to coughing or a sensation of choking. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Choking or Coughing) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "difficulty with voice or speech" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to voice production and quality or speech. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Difficulty with Voice or Speech) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "skin pain, burning or rash" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to the sensation of pain and/or burning and/or presence of a rash in irradiated areas of the skin. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Skin Pain, Burning or Rash) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "constipation" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to constipation and bowel function. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Constipation) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "problems with tasting food" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to the sensation of taste. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Problems with Tasting Food) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "mouth or throat sores" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to sores or lesions present in the mouth and throat. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Mouth or Throat Sores) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "problems with teeth or gums" domain items of the MD Anderson Symptom Inventory tool. The measure is derived from a subset of 11-item Likert-style questions presented in the full inventory tool that assess symptoms relevant to oral health particularly the teeth and gums. Responses range from 0 (no 'symptom') to 10 (severe 'symptom').
Measure: MD Anderson Symptom Inventory for Head and Neck Domain Score (Problems with Teeth or Gums) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure comprises a single five-item, Likert-style question with responses ranging from 'Strongly Agree' to 'Strongly Disagree'. A higher score ('Strongly Agree') corresponds to a worse outcome.
Measure: MD Anderson Dysphagia Inventory Global Score Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure comprises 19 five-item, Likert-style questions with responses ranging from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') corresponds to worse traits or more severe symptoms.
Measure: MD Anderson Dysphagia Inventory Composite Score Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "emotional" domain comprising a subset of five-item, Likert-style questions of the MD Anderson Dysphagia Inventory Composite tool that assesses symptoms relevant to emotional health. Responses range from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') correspond to worse traits or more severe symptoms.
Measure: MD Anderson Dysphagia Inventory Score (Emotional) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "functional" domain comprising a subset of five-item, Likert-style questions of the MD Anderson Dysphagia Inventory Composite tool that assesses symptoms relevant to the ability to function in daily life activities. Responses range from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') correspond to worse traits or more severe symptoms.
Measure: MD Anderson Dysphagia Inventory Score (Functional) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: This measure is the score for the "physical" domain comprising a subset of five-item, Likert-style questions of the MD Anderson Dysphagia Inventory Composite tool that assesses symptoms relevant to the ability to perform physical activities. Responses range from 'Strongly Agree' to 'Strongly Disagree'. Questions are worded such that higher scores ('Strongly Agree') correspond to worse traits or more severe symptoms.
Measure: MD Anderson Dysphagia Inventory Score (Physical) Time: Baseline; weeks 1, 2, and 3 during radiotherapy; weeks 1, 2, 3, 4 and months 3, 6, 9 and 12 following fraction 1Description: The Eating Assessment Tool comprises 10 five-item, Likert-style questions querying various aspects of swallowing. Responses range from 0 (No problem) to 4 (Severe problem). The total of the responses represents the EAT-10 score. Higher numbers indicate poorer swallowing ability.
Measure: Eating Assessment Tool (EAT-10) Score Time: Baseline, and months 3 and 6 following fraction 1Description: The Functional Oral Intake Scale is a clinician-completed ordinal rating scale ranging from 1 (No oral intake) to 7 (Total oral intake with no restrictions). Higher numbers indicate more favorable feeding capability.
Measure: Functional Oral Intake Scale (FOIS) Time: Baseline, and months 3 and 6 following fraction 1Description: The DIGEST grade is a five-item modified barium swallow scale for grading pharyngeal dysphagia as a toxicity endpoint. The DIGEST grade responses are: grade 1= mild, grade 2= moderate, grade 3= severe, and grade 4= life threatening pharyngeal dysphagia.
Measure: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Grade Time: Baseline, and months 3 and 6 following fraction 1Project EXCEL will provide community or online exercise programs to rural and remote and under-served cancer survivors, as well as encourage participants to become life-long exercisers. Exercise is an evidence-based self-management strategy that benefits all cancer survivors. However, most cancer survivors who live in remote or rural places don't have adequate opportunities to be involved in exercise programs that are tailored to their needs.
NCT04478851 Cancer Head and Neck Cancer Colon Cancer Breast Cancer Prostate Cancer Cancer Caregivers Behavioral: Group Exercise Classes MeSH:Head and Neck Neoplasms
HPO:Neoplasm of head and neck
Primary Outcomes
Description: Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise, based on accelerometer data from commercially-available activity tracker.
Measure: Physical Activity Minutes Per Week Time: Baseline to one-year
Secondary Outcomes
Description: Change in body mass index (BMI)
Measure: Body Composition Time: Baseline to post 12-week exercise intervention
Description: Change in 6-minute walk test (m) or 2 minute step test (steps) results
Measure: Aerobic Endurance Time: Baseline to post 12-week exercise intervention
Description: Change in hand-grip dynamometry (kg)
Measure: Upper extremity grip strength Time: Baseline to post 12-week exercise intervention
Description: Change in sit-to-stand (number of repetitions in 30 seconds)
Measure: Functional performance test Time: Baseline to post 12-week exercise intervention
Description: Change in active shoulder flexion range of motion (degrees)
Measure: Upper extremity flexibility Time: Baseline to post 12-week exercise intervention
Description: Change in sit-and-reach test (cm)
Measure: Lower extremity flexibility Time: Baseline to post 12-week exercise intervention
Description: Change in one legged stance test (seconds)
Measure: Balance Time: Baseline to post 12-week exercise intervention
Description: Change in fatigue, mood, and QOL, recorded via m-Health app
Measure: Symptom tracking Time: Baseline to one year
Description: Change in Edmonton Symptom Assessment Scale.
- scale is from 0-10, where 0 means the symptom is absent and 10 means the worst possible severity of the symptom is being experienced.
Measure: Cancer related symptoms Time: Baseline to one year
Description: Change in Godin Leisure Time Exercise Questionnaire
Measure: Subjective reporting of average weekly physical activity Time: Baseline to one year
Description: Change in EuroQual - 5Dimensions (EQ-5D) tool
- first section is a questionniare; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable.
Measure: General Health-related Quality of Life Time: Baseline to one year
Description: Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale
- scale is from 0-4, where 0 means "not at all" and 4 means "very much".
Measure: Fatigue Time: Baseline to one year
Description: Change in Functional Assessment of Cancer Therapy - General subscale
- scale is from 0-4, where 0 means "not at all" and 4 means "very much".
Measure: General well-being Time: Baseline to one year
Description: Change in Functional Assessment of Cancer Therapy - Cognitive subscale
- scale is from 0-4, where 0 means "never" and 4 means "several times a day" (experiencing symptoms).
Measure: Cognition Time: Baseline to one year
Description: Change in Exercise Barriers and Facilitators questionnaire
Measure: Barriers and facilitators to exercise participation Time: Baseline to one year
Description: Adherence to exercise programming (attendance at sessions)
Measure: Exercise adherence Time: Baseline to one year
Description: RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
Measure: Program implementation and evaluation Time: Baseline to one year
HPO Nodes
Primary Outcomes
Description: Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise, based on accelerometer data from commercially-available activity tracker.
Measure: Physical Activity Minutes Per Week Time: Baseline to one-yearSecondary Outcomes
Description: Change in body mass index (BMI)
Measure: Body Composition Time: Baseline to post 12-week exercise interventionDescription: Change in 6-minute walk test (m) or 2 minute step test (steps) results
Measure: Aerobic Endurance Time: Baseline to post 12-week exercise interventionDescription: Change in hand-grip dynamometry (kg)
Measure: Upper extremity grip strength Time: Baseline to post 12-week exercise interventionDescription: Change in sit-to-stand (number of repetitions in 30 seconds)
Measure: Functional performance test Time: Baseline to post 12-week exercise interventionDescription: Change in active shoulder flexion range of motion (degrees)
Measure: Upper extremity flexibility Time: Baseline to post 12-week exercise interventionDescription: Change in sit-and-reach test (cm)
Measure: Lower extremity flexibility Time: Baseline to post 12-week exercise interventionDescription: Change in one legged stance test (seconds)
Measure: Balance Time: Baseline to post 12-week exercise interventionDescription: Change in fatigue, mood, and QOL, recorded via m-Health app
Measure: Symptom tracking Time: Baseline to one yearDescription: Change in Edmonton Symptom Assessment Scale. - scale is from 0-10, where 0 means the symptom is absent and 10 means the worst possible severity of the symptom is being experienced.
Measure: Cancer related symptoms Time: Baseline to one yearDescription: Change in Godin Leisure Time Exercise Questionnaire
Measure: Subjective reporting of average weekly physical activity Time: Baseline to one yearDescription: Change in EuroQual - 5Dimensions (EQ-5D) tool - first section is a questionniare; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable.
Measure: General Health-related Quality of Life Time: Baseline to one yearDescription: Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale - scale is from 0-4, where 0 means "not at all" and 4 means "very much".
Measure: Fatigue Time: Baseline to one yearDescription: Change in Functional Assessment of Cancer Therapy - General subscale - scale is from 0-4, where 0 means "not at all" and 4 means "very much".
Measure: General well-being Time: Baseline to one yearDescription: Change in Functional Assessment of Cancer Therapy - Cognitive subscale - scale is from 0-4, where 0 means "never" and 4 means "several times a day" (experiencing symptoms).
Measure: Cognition Time: Baseline to one yearDescription: Change in Exercise Barriers and Facilitators questionnaire
Measure: Barriers and facilitators to exercise participation Time: Baseline to one yearDescription: Adherence to exercise programming (attendance at sessions)
Measure: Exercise adherence Time: Baseline to one yearDescription: RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
Measure: Program implementation and evaluation Time: Baseline to one year