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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00204 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 01416 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase II trial studies how well palliative radiation therapy works in reducing pain in patients with cancer that has spread from the original (primary) tumor to the bone (bone metastasis). Palliative radiation therapy using external beam radiation therapy may help patients with bone metastasis to relieve symptoms and reduce pain caused by cancer.
PRIMARY OBJECTIVES:
I. To determine whether 8 gray (Gy) x 2 fractions results in lower re-treatment rates compared to 8 Gy x 1 fraction.
SECONDARY OBJECTIVES:
I. To determine whether 8 Gy x 2 fractions provides superior pain and narcotic relief compared to 8 Gy x 1 fraction.
II. To determine whether 8 Gy x 2 fractions is associated with improved quality of life compared to 8 Gy x 1 fraction.
III. To determine whether use of a bone strengthening agent is associated with improved pain relief, narcotic relief and re-treatment rates.
IV. To determine if 8 Gy x 2 fractions is associated with increased toxicity. V. To correlate patient satisfaction, perceived stress, and social support with treatment outcomes.
TERTIARY OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo 1 fraction of external beam radiation therapy (EBRT) over 30 minutes.
ARM II: Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
After completion of study treatment, patients are followed up at 30 days and at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM I (palliative radiation therapy) | Experimental | Patients undergo 1 fraction of EBRT over 30 minutes. |
|
| ARM II (palliative radiation therapy) | Experimental | Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Beam Radiation Therapy | Radiation | Undergo EBRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2) | The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis. | Up to 6 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale | Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion. | At 3 months and 6 months post-treatment |
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Inclusion Criteria:
Diagnosis of cancer, not including multiple myeloma
Radiographic evidence of bone metastases within 8 weeks of study; the patient must have pain which appears to be related to the radiographically documented metastasis in the opinion of the treating physician, and the decision has been made by the responsible clinician that a course of palliative external beam radiation therapy is appropriate treatment; multiple sites eligible if they can be included in no greater than 3 treatment sites
Eligible treatment sites are:
Weight bearing sites
Non-weight bearing sites
Pain score of at least 5 on a scale of 0 - 10 within a week of enrollment OR pain score < 5 with >= 60 mg of morphine (or equivalent) per day
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Negative pregnancy test at study registration
Changes in systemic chemotherapy, hormonal therapy or the use of bisphosphonates for 4 weeks before and after the delivery of radiotherapy are allowed, but recording and accounting for this in the statistical analysis is required
Life expectancy of at least 12 weeks as deemed by the treating oncologist
Patients will be eligible for treatment of multiple osseous sites only if those sites can be included in no more than three treatment sites; for patients with painful metastases that are contiguous but do not fit into the definition of a site listed above, those patients will still be eligible but will be considered to have two treatment sites; for example, a patient with a lesion of T4, T7 and T9 would be eligible but would be considered as two treatment sites since more than five consecutive vertebral bodies would be treated; these lesions could be treated with one field, even though the treatment is coded as two sites
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doris R Brown | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Control) 8 Gy x 1 | Patients undergo 1 fraction of EBRT over 30 minutes. |
| FG001 | Arm B (Treatment) 8 Gy x 2 | Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2021 |
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| Palliative Radiation Therapy | Radiation | Undergo EBRT |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use | Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion. The variable for pain response is categorical rather than continuous and will be compared between groups using a Fisher's exact test. The rating pain scale is from 0-10, with 0 being no pain, 8-10 worst possible pain. | At 3 months and 6 months post-treatment |
| Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Analyses will be performed that examine whether there are associations between quality of life and treatment outcome (re-treatment rates or amount of pain relief). Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Either multiple logistic regression (for binary outcomes) models or analysis of covariance (ANCOVA) models for continuous outcomes will be used. The QLQ-C15-PAL has high sensitivity and specificity for identifying clinically important symptoms and functional health impairments. Scores range from 0 to 100 with higher values indicating a better quality of life in the Physical and Emotional Functioning and Quality of Life categories. Higher scores in Symptoms Scales categories indicates a worse quality of life. Most questions are rated on a 4-point Likert scale (1 = not at all to 4 = very much), but the global quality of life item uses a 7-point scale (1 = very poor to 7 = excellent) | At 3 months and 6 months post-treatment |
| Incidence of Adverse Events - Grade 3 or Higher | Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Groups will be compared to determine whether there are any differences in the number or severity of toxicities. When comparing severity of toxicities between groups, chi-square tests will be examined. The Cochran-Armitage trend test can be used to determine if there is evidence a trend in severity of toxicities when comparing groups. Because of the patient population as well as the treatment, emphasis will be placed on gastrointestinal (GI disturbance, esophagitis, diarrhea, nausea, and vomiting), hematological (low blood counts or bleeding), spinal (bone fracture, compression fracture, insufficiency, or myelitis), and pulmonary toxicities (pneumonitis) and recorded by clinical research coordinators. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to the event. | Up to 6 months post-treatment |
| Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18) | Analyses will be performed that examine whether there are associations between patient satisfaction and treatment outcome (re-treatment rates or amount of pain relief). Satisfaction will be measured by answering a series of questions with a scoring scale range of 1 (strongly agree) to 5 (strongly disagree). The scoring range for the Patient Satisfaction with Cancer Care (PSCC)-18 is 18 (best score) to 90 (worse score). A lower total score indicates higher satisfaction with cancer care. | At 3 months and 6 months post-treatment |
| Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | The Perceived Stress Scale (PSS) is a stress assessment instrumentto help understand how different situations affect feelings and perceived stress. Scoring scale is 1 (never) to 4 (very often) when monitoring stress, the higher the total score the more stress the participant has experienced. The Perceived Stress Scale (PSS-10) is scored by summing the responses to all 10 items, with a total score ranging from 0 to 40. To get the score, you first need to reverse the scoring for the positively worded items (items 4, 5, 7, and 8). A total score of 0-13 suggests low stress, 14-26 indicates moderate stress, and 27-40 represents high stress. Perceived helplessness (items 1, 2, 3, 6, 9, 10) - measuring an individual's feelings of a lack of control over their circumstances or their own emotions or reactions. Lack of self-efficacy (items 4, 5, 7, 8) - measuring an individual's perceived inability to handle problems. | At 3 months and 6 months post-treatment |
| Participants With Social Support Assessed Via Self-Reported Surveys | Association between social support and treatment outcomes will be assessed. Social support will be measured by answering a series of questions with a scoring scale range of 1 (definitely false for you) to 4 (definitely true for you). The total score is the sum of all items, ranging from 0 to 36. Sum the scores for the four items in each subscale (Appraisal, Belonging, and Tangible) to get a score ranging from 0 to 12 for each subscale. The higher the total score the more support the participants receive from their support network. | At 3 months and 6 months post-treatment |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Control) 8 Gy x 1 | Patients undergo 1 fraction of EBRT over 30 minutes. |
| BG001 | Arm B (Treatment) 8 Gy x 2 | Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Currently using bisphosphonates/ Denosumab? | Count of Participants | Participants |
| ||||||||||||||||
| Any prior cancer therapy | Count of Participants | Participants |
| ||||||||||||||||
| History of weight loss? | Count of Participants | Participants |
| ||||||||||||||||
| Medical History | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance Status | Score 0 - Fully active, able to carry on all pre-disease performance without restriction. Score 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Score 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. Score 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2) | The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis. | Analysis was performed with death as a competing risk. | Posted | Count of Participants | Participants | Up to 6 months post-treatment |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale | Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion. | Posted | Mean | Standard Deviation | score on a scale | At 3 months and 6 months post-treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use | Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion. The variable for pain response is categorical rather than continuous and will be compared between groups using a Fisher's exact test. The rating pain scale is from 0-10, with 0 being no pain, 8-10 worst possible pain. | Posted | Mean | Standard Deviation | MME per day | At 3 months and 6 months post-treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL) | Analyses will be performed that examine whether there are associations between quality of life and treatment outcome (re-treatment rates or amount of pain relief). Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Either multiple logistic regression (for binary outcomes) models or analysis of covariance (ANCOVA) models for continuous outcomes will be used. The QLQ-C15-PAL has high sensitivity and specificity for identifying clinically important symptoms and functional health impairments. Scores range from 0 to 100 with higher values indicating a better quality of life in the Physical and Emotional Functioning and Quality of Life categories. Higher scores in Symptoms Scales categories indicates a worse quality of life. Most questions are rated on a 4-point Likert scale (1 = not at all to 4 = very much), but the global quality of life item uses a 7-point scale (1 = very poor to 7 = excellent) | Posted | Mean | Standard Deviation | score on a scale | At 3 months and 6 months post-treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events - Grade 3 or Higher | Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Groups will be compared to determine whether there are any differences in the number or severity of toxicities. When comparing severity of toxicities between groups, chi-square tests will be examined. The Cochran-Armitage trend test can be used to determine if there is evidence a trend in severity of toxicities when comparing groups. Because of the patient population as well as the treatment, emphasis will be placed on gastrointestinal (GI disturbance, esophagitis, diarrhea, nausea, and vomiting), hematological (low blood counts or bleeding), spinal (bone fracture, compression fracture, insufficiency, or myelitis), and pulmonary toxicities (pneumonitis) and recorded by clinical research coordinators. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to the event. | Posted | Number | participants | Up to 6 months post-treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18) | Analyses will be performed that examine whether there are associations between patient satisfaction and treatment outcome (re-treatment rates or amount of pain relief). Satisfaction will be measured by answering a series of questions with a scoring scale range of 1 (strongly agree) to 5 (strongly disagree). The scoring range for the Patient Satisfaction with Cancer Care (PSCC)-18 is 18 (best score) to 90 (worse score). A lower total score indicates higher satisfaction with cancer care. | Posted | Mean | Standard Deviation | score on a scale | At 3 months and 6 months post-treatment |
|
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| Secondary | Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10) | The Perceived Stress Scale (PSS) is a stress assessment instrumentto help understand how different situations affect feelings and perceived stress. Scoring scale is 1 (never) to 4 (very often) when monitoring stress, the higher the total score the more stress the participant has experienced. The Perceived Stress Scale (PSS-10) is scored by summing the responses to all 10 items, with a total score ranging from 0 to 40. To get the score, you first need to reverse the scoring for the positively worded items (items 4, 5, 7, and 8). A total score of 0-13 suggests low stress, 14-26 indicates moderate stress, and 27-40 represents high stress. Perceived helplessness (items 1, 2, 3, 6, 9, 10) - measuring an individual's feelings of a lack of control over their circumstances or their own emotions or reactions. Lack of self-efficacy (items 4, 5, 7, 8) - measuring an individual's perceived inability to handle problems. | Posted | Mean | Standard Deviation | score on a scale | At 3 months and 6 months post-treatment |
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| Secondary | Participants With Social Support Assessed Via Self-Reported Surveys | Association between social support and treatment outcomes will be assessed. Social support will be measured by answering a series of questions with a scoring scale range of 1 (definitely false for you) to 4 (definitely true for you). The total score is the sum of all items, ranging from 0 to 36. Sum the scores for the four items in each subscale (Appraisal, Belonging, and Tangible) to get a score ranging from 0 to 12 for each subscale. The higher the total score the more support the participants receive from their support network. | Posted | Mean | Standard Deviation | score on a scale | At 3 months and 6 months post-treatment |
|
|
Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARM I (Palliative Radiation Therapy) | Patients undergo 1 fraction of EBRT over 30 minutes. External Beam Radiation Therapy: Undergo EBRT Palliative Radiation Therapy: Undergo EBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 19 | 51 | 19 | 51 | 32 | 51 |
| EG001 | ARM II (Palliative Radiation Therapy) | Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days. External Beam Radiation Therapy: Undergo EBRT Palliative Radiation Therapy: Undergo EBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 17 | 51 | 37 | 51 | 32 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colonic obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Enterocolitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
| ||
| Death, NOS | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Gait disturbance | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Abdominal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Lung infection | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Spinal fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Injury, poisoning and procedures complications, other | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Non-systematic Assessment |
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| Acute kidney pain | Renal and urinary disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Chest pain - cardiac | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Vestibular disorder | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
| ||
| Blurred vision | Eye disorders | Non-systematic Assessment |
| ||
| Dry eye | Eye disorders | Non-systematic Assessment |
| ||
| Eye pain | Eye disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
| ||
| Edema, limbs | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Bronchial infection | Infections and infestations | Non-systematic Assessment |
| ||
| Infections and infestation | Infections and infestations | Non-systematic Assessment |
| ||
| Papulopustular rash | Infections and infestations | Non-systematic Assessment |
| ||
| Skin infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Spinal fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Wound complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Non-systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| Weight loss | Investigations | Non-systematic Assessment |
| ||
| White blood cell decreased | Investigations | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Glucose intolerance | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypermagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Musculoskeletal deformity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| Spasticity | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Tremor | Nervous system disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Restlessness | Psychiatric disorders | Non-systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary tract pain | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Genital edema | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pleural hemorrhage | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Erythema multiforme | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash acneiform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash maculopapular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Wake Forest Baptist Comprehensive Cancer Center | 3367135440 | Doris.R.Brown@advocatehealth.org |
| Aug 21, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2024 | Apr 24, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Black or African American |
|
| Asian Indian/Asian |
|
| Unable to obtain |
|
| Congestive heart failure |
|
| Peripheral vascular disease |
|
| Cerebrovascular disease |
|
| Dementia |
|
| Chronic pulmonary disease |
|
| Connective tissue disease |
|
| Peptic ulcer disease |
|
| Liver disease |
|
| Diabetes |
|
| Hemiplegia |
|
| Other cancer |
|
| AIDS |
|
| Other sites of metastases |
|
| Brain |
|
| Liver |
|
| 2-3 |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
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| Units | Counts |
|---|---|
| Participants |
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