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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00078659 | Other Identifier | JHMIRB |
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The Investigators are looking to compare standard treatment for the management of small cell lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in patient survival) with cranial sparing PCI. Although standard of care PCI is successful in patient survival it also has neurologic side-effects. The Investigators are hoping the cranial sparing PCI has the same positive survival results with the added benefit of lowering neurological side-effects.
The standard of care in management of small cell lung cancer consists of chemotherapy plus thoracic radiation followed by prophylactic cranial irradiation (PCI) based on a randomized trial that demonstrated a significant improvement in overall survival (OS) with PCI. Unfortunately radiation therapy to the brain is associated with neurocognitive toxicity, which may be at least in part related to radiation induced injury to neural progenitor cells in the hippocampus. Both human and animal data suggest an inverse relationship between radiation dose to the hippocampus and performance on neuropsychological testing. We hypothesize that hippocampal sparing PCI will allow improved performance on tests of short term memory and executive function compared to a historical control (RTOG 0212) receiving the same dose of conventional PCI. The primary objective of this study is to evaluate performance on the Hopkins Verbal Learning Test-Revised for delayed recall at 6 months following hippocampal-sparing PCI relative to the historical control. Secondary objectives are to estimate: 1) composite cognitive function following hippocampal-sparing PCI relative to the historical control and 2) the rate of metastases in the hippocampus at 2 years following hippocampal-sparing PCI. The long term goal of this research is to reduce the long term sequelae of radiation therapy for both primary and metastatic brain tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hippocampal-sparing PCI | Experimental | Hippocampal-sparing PCI 25 Gy in 10 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hippocampal-sparing Prophylactic Cranial Irradiation | Radiation | Hippocampal-sparing Prophylactic Cranial Irradiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall | The primary endpoint of this study is cognitive function or memory. Memory is measured by participant performance on the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-Delayed Recall) at 6 months following hippocampal-sparing PCI. The HVLT-Delayed minimum and Maximum scores are 0-12. A higher score means a better outcome. | Baseline, 6 months and 12 months post radiation treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R)
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Redmond, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bayview Medical Center | Baltimore | Maryland | 21227 | United States | ||
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28581401 | Derived | Redmond KJ, Hales RK, Anderson-Keightly H, Zhou XC, Kummerlowe M, Sair HI, Duhon M, Kleinberg L, Rosner GL, Vannorsdall T. Prospective Study of Hippocampal-Sparing Prophylactic Cranial Irradiation in Limited-Stage Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):603-611. doi: 10.1016/j.ijrobp.2017.03.009. Epub 2017 Mar 14. |
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There is no plan to share data with PIs who are not included on the study team.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hippocampal-sparing PCI | Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hippocampal-sparing PCI | Hippocampal-sparing PCI 25 Gy in 10 fractions Hippocampal-sparing Prophylactic Cranial Irradiation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall | The primary endpoint of this study is cognitive function or memory. Memory is measured by participant performance on the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-Delayed Recall) at 6 months following hippocampal-sparing PCI. The HVLT-Delayed minimum and Maximum scores are 0-12. A higher score means a better outcome. | At the 6 month timepoint, only 17 participants completed the test, and at the 12 month time point only 14 participants took the test. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months and 12 months post radiation treatment |
|
Adverse events were followed for a one-year period.
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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 | Hippocampal-sparing PCI | Hippocampal-sparing PCI 25 Gy in 10 fractions Hippocampal-sparing Prophylactic Cranial Irradiation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| The SKCCC at Johns Hopkins | The SKCCC at Johns Hopkins | 4109556980 | kjansen3@jhmi.edu |
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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 | Nov 14, 2013 | Jun 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Baseline |
| Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R)
| 6 months post radiation treatment |
| Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R)
| 12 months post radiation treatment |
| Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 6 months and baseline. Questions on the Quality of Life Questionnaire (QLQ-C30) assessment are on a four-point scale from "not at all" to "very much". Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. Questions on the QLQ-C30 cover the following:
| Baseline and 6 months post radiation treatment |
| Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 12 months and baseline. Questions on the Quality of Life Questionnaire (QLQ-C30) assessment are on a four-point scale from "not at all" to "very much". Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. Questions on the QLQ-C30 cover the following:
| Baseline and 12 months post radiation treatment |
| Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 6 months and baseline. Questions on the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) are rated on a four-point scale ('not at all', 'a little', 'quite a bit' and 'very much'), and are linearly transformed to a 0-100 scale. Higher scores represent more severe symptoms. Questions on the QLQ-BN20 cover the following:
| Baseline and 6 months post radiation treatment |
| Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 12 months and baseline. Questions on the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) are rated on a four-point scale ('not at all', 'a little', 'quite a bit' and 'very much'), and are linearly transformed to a 0-100 scale. Higher scores represent more severe symptoms. Questions on the QLQ-BN20 cover the following:
Headaches Seizures Drowsy Hair loss Itching Weakness Bladder Future Uncertainty Scale Visual Disorder Scale Motor Dysfunction Scale Communication Deficit Scale | Baseline and 12 months post radiation treatment |
| Number Participants With Hippocampus Brain Metastases Following Sparing PCI | The number of participants with brain metastases after sparing PCI treatment was assessed to be compared to two existing studies. | 12 months |
| Assess if Development of Leptomeningeal Carcinomatosis Following Sparing PCI is Higher Than Expected | Determine whether development of leptomeningeal carcinomatosis following hippocampal-sparing PCI is higher than expected. | 6 months, 12 months, 18 months and 24 months post radiation treatment |
| Percentage of Participants Surviving Following Hippocampal-sparing PCI | To evaluate the survival rates of study participants following hippocampal-sparing PCI. | Up to 24 months post radiation treatment |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R)
| Data is presented for Hippocampal-sparing PCI (from this study). 19 participants completed the test at baseline. No data from standard PCI for comparison to be done. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R)
| Data is presented for Hippocampal-sparing PCI (from this study). 14 participants completed the test at 6 months. No data from standard PCI for comparison to be done. | Posted | Mean | Standard Deviation | score on a scale | 6 months post radiation treatment |
|
|
|
| Secondary | Compare Cognitive Function Following Sparing PCI to That of Standard PCI | Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R)
| Data is presented for Hippocampal-sparing PCI (from this study). 14 participants completed the test at 12 months. No data from standard PCI for comparison to be done. | Posted | Mean | Standard Deviation | score on a scale | 12 months post radiation treatment |
|
|
|
| Secondary | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 6 months and baseline. Questions on the Quality of Life Questionnaire (QLQ-C30) assessment are on a four-point scale from "not at all" to "very much". Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. Questions on the QLQ-C30 cover the following:
| Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months post radiation treatment |
|
|
|
| Secondary | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 12 months and baseline. Questions on the Quality of Life Questionnaire (QLQ-C30) assessment are on a four-point scale from "not at all" to "very much". Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. Questions on the QLQ-C30 cover the following:
| Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post radiation treatment |
|
|
|
| Secondary | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 6 months and baseline. Questions on the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) are rated on a four-point scale ('not at all', 'a little', 'quite a bit' and 'very much'), and are linearly transformed to a 0-100 scale. Higher scores represent more severe symptoms. Questions on the QLQ-BN20 cover the following:
| Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months post radiation treatment |
|
|
|
| Secondary | Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). | Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 12 months and baseline. Questions on the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) are rated on a four-point scale ('not at all', 'a little', 'quite a bit' and 'very much'), and are linearly transformed to a 0-100 scale. Higher scores represent more severe symptoms. Questions on the QLQ-BN20 cover the following:
Headaches Seizures Drowsy Hair loss Itching Weakness Bladder Future Uncertainty Scale Visual Disorder Scale Motor Dysfunction Scale Communication Deficit Scale | Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post radiation treatment |
|
|
|
| Secondary | Number Participants With Hippocampus Brain Metastases Following Sparing PCI | The number of participants with brain metastases after sparing PCI treatment was assessed to be compared to two existing studies. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Assess if Development of Leptomeningeal Carcinomatosis Following Sparing PCI is Higher Than Expected | Determine whether development of leptomeningeal carcinomatosis following hippocampal-sparing PCI is higher than expected. | Data for this outcome measure was not collected. | Posted | 6 months, 12 months, 18 months and 24 months post radiation treatment |
|
|
| Secondary | Percentage of Participants Surviving Following Hippocampal-sparing PCI | To evaluate the survival rates of study participants following hippocampal-sparing PCI. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24 months post radiation treatment |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| Alopecia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dsypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Memory Loss | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Taste Disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain due to radiation therapy | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucus | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness/lightheaded | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomit | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pharynx and esophogus | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ocular Visual | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Personality Behavioral | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hearing Changes | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot Flash | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Voice changes | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| Trail Making A |
|
| Trail Making B |
|
| COWA |
|
| MMSE |
|
| PCT |
|
| BTA |
|
| CIFA: Letter Word Fluency |
|
| CIFA: Category Word Fluency |
|
| CIFA: Verbal Fluency |
|
| BVMT-R Total Recall |
|
| BVMT-R Delayed Recall |
|
| BVMT-R Discrimination |
|
| Learning and Memory: Verbal |
|
| Learning and Memory: Visual |
|
| Title | Measurements |
|---|---|
|
| Trail Making A |
|
| Trail Making B |
|
| COWA |
|
| MMSE |
|
| PCT |
|
| BTA |
|
| CIFA: Letter Word Fluency |
|
| CIFA: Category Word Fluency |
|
| CIFA: Verbal Fluency |
|
| BVMT-R Total Recall |
|
| BVMT-R Delayed Recall |
|
| BVMT-R Discrimination |
|
| Learning and Memory: Verbal |
|
| Learning and Memory: Visual |
|
| Title | Measurements |
|---|---|
|
| Trail Making A |
|
| Trail Making B |
|
| COWA |
|
| MMSE |
|
| PCT |
|
| BTA |
|
| CIFA: Letter Word Fluency |
|
| CIFA: Category Word Fluency |
|
| CIFA: Verbal Fluency |
|
| BVMT-R Total Recall |
|
| BVMT-R Delayed Recall |
|
| BVMT-R Discrimination |
|
| Learning and Memory: Verbal |
|
| Learning and Memory: Visual |
|
| Title | Measurements |
|---|---|
|
| Constipation |
|
| Diarrhoea |
|
| Finances |
|
| Fatigue |
|
| Nausea/Vomiting |
|
| Pain |
|
| Physical Function |
|
| Role Function |
|
| Emotional Function |
|
| Cognitive Function |
|
| Social Function |
|
| Global QoL |
|
| Title | Measurements |
|---|---|
|
| Constipation |
|
| Diarrhoea |
|
| Finances |
|
| Fatigue |
|
| Nausea/Vomiting |
|
| Pain |
|
| Physical Function |
|
| Role Function |
|
| Emotional Function |
|
| Cognitive Function |
|
| Social Function |
|
| Global QoL |
|
| Title | Measurements |
|---|---|
|
| Hair loss |
|
| Itching |
|
| Weakness |
|
| Bladder |
|
| Future Uncertainty |
|
| Visual Disorder |
|
| Motor Dysfunction |
|
| Communication Deficit |
|
| Title | Measurements |
|---|---|
|
| Hair loss |
|
| Itching |
|
| Weakness |
|
| Bladder |
|
| Future Uncertainty |
|
| Visual Disorder |
|
| Motor Dysfunction |
|
| Communication Deficit |
|