Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1P50CA196530-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| VA Connecticut Healthcare System | FED |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. The primary outcomes will include number of patients increasing their overall step count over the study period and adherence to step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea, and depression scores before and after the intervention as well as a patient feedback questionnaire (to guide further interventions). The goals are to increase overall step count and obtain adherence of >50% of participants. The investigators will also assess whether the physical activity regimen influences markers of inflammation and glucose control and novel markers of cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2). |
|
| Control Group | No Intervention | Usual care group will receive standard of care management from their Oncologist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescribed Activity | Behavioral | Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Step Count | Participants will wear a Fitbit wrist band that will record step count. | baseline to 12 weeks |
| Number of Weeks Participants Adhered to Step Count Recommendations | Exercise Adherence will be defined as (the number of weeks a subject follows the activity prescription)/(the number of "usable" weeks). A week is considered "usable" if 5/7 days of step counts are available, and days with <200 steps/day are considered not usable. | baseline to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea | Assessed via self-report using the Modified Medical Research Council. Dyspnea Scale, a single-item scale scored 0-4; higher score indicates worse dyspnea. | change from pre- to post-intervention (week 12) |
| Depression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brett Bade, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33794808 | Derived | Bade BC, Gan G, Li F, Lu L, Tanoue L, Silvestri GA, Irwin ML. "Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study". BMC Cancer. 2021 Apr 1;21(1):352. doi: 10.1186/s12885-021-08084-0. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2). Prescribed Activity: Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2) |
| FG001 | Control Group | Usual care group will receive standard of care management from their Oncologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2). Prescribed Activity: Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Overall Step Count | Participants will wear a Fitbit wrist band that will record step count. | This outcome was measured only in the intervention group. | Posted | Mean | Full Range | Steps | baseline to 12 weeks |
|
Twelve weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2). Prescribed Activity: Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brett Bade | Yale University | 203 785 6670 | Brett.bade@yale.edu |
Not provided
| 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 6, 2020 | Apr 2, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2020 | Feb 13, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assessed via self-report using the Patient Health Questionnaire, Depression Module (PHQ-9). a 9-item questionnaire that assesses depressive symptoms over the preceding two weeks. Each item is scored 0-3 (0 = "Not at all"; 1 = "Several days"; 2 = "More than half of days"; 3 = "Nearly every day"). A total score is calculated by taking the sum of questions 1-9, and a higher score indicates worse depression.
| change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Global Health Status | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales: Global health status/Quality of Life (QoL) scale, range 0-100, higher score = better quality of life. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Physical Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measure physical functioning. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Role Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures role functioning. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Emotional Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures emotional functioning. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Fatigue | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures fatigue. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Cognitive Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures cognitive functioning. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Nausea/Vomiting | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures nausea and vomiting The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Pain | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures pain. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Social Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures social functioning. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Dyspnea | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure dyspnea. The range of score is 0-100; higher score = higher symptoms burden. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Insomnia | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure insomnia. The range of score is 0-100; higher score = better functioning. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Appetite Loss | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure appetite loss The range of score is 0-100; higher score = higher symptoms burden. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Constipation | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure constipation. The range of score is 0-100; higher score = higher symptoms burden. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Diarrhea | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure diarrhea. The range of score is 0-100; higher score = higher symptoms burden. | change from pre- to post-intervention (week 12) |
| Change in Quality of Life: Financial Difficulties | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure financial difficulties. The range of score is 0-100; higher score = higher symptoms burden. | change from pre- to post-intervention (week 12) |
| Moderate Aerobic Exercise | The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes. | baseline to 12 weeks |
| Vigorous Aerobic Exercise | The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes. | baseline to 12 weeks |
| Change in C-reactive Protein (CRP) | The investigators will obtain serum CRP, a marker of inflammation. | change from pre- to post-intervention (week 12) |
| Change in Leptin Level | The investigators will obtain serum leptin, a marker of glucose control. . | change from pre- to post-intervention (week 12) |
| Change in Insulin Level | The investigators will obtain serum insulin level, a measure of glucose control. | change from pre- to post-intervention (week 12) |
| Programmed Death - Ligand | The investigators will collect soluble PD- L1, a novel cancer marker. | change from pre- to post-intervention (week 12) |
| Programmed Cell Death (PD-1) | The investigators will collect soluble PD- 1, a novel cancer marker. | change from pre- to post-intervention (week 12) |
| BG001 | Control Group | Usual care group will receive standard of care management from their Oncologist. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Usual care group will receive standard of care management from their Oncologist. |
|
|
| Primary | Number of Weeks Participants Adhered to Step Count Recommendations | Exercise Adherence will be defined as (the number of weeks a subject follows the activity prescription)/(the number of "usable" weeks). A week is considered "usable" if 5/7 days of step counts are available, and days with <200 steps/day are considered not usable. | This outcome was measured only in the intervention group. The 19 participants were each followed for 12 weeks. Thus 19 participants were followed for a total of 228 weeks. | Posted | Count of Units | Weeks | baseline to 12 weeks. | Weeks | Weeks |
|
|
|
| Secondary | Dyspnea | Assessed via self-report using the Modified Medical Research Council. Dyspnea Scale, a single-item scale scored 0-4; higher score indicates worse dyspnea. | Posted | Least Squares Mean | Standard Error | score on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Depression | Assessed via self-report using the Patient Health Questionnaire, Depression Module (PHQ-9). a 9-item questionnaire that assesses depressive symptoms over the preceding two weeks. Each item is scored 0-3 (0 = "Not at all"; 1 = "Several days"; 2 = "More than half of days"; 3 = "Nearly every day"). A total score is calculated by taking the sum of questions 1-9, and a higher score indicates worse depression. | Posted | Least Squares Mean | Standard Error | score on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Global Health Status | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales: Global health status/Quality of Life (QoL) scale, range 0-100, higher score = better quality of life. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Physical Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measure physical functioning. The range of score is 0-100; higher score = better functioning. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Role Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures role functioning. The range of score is 0-100; higher score = better functioning. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Emotional Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures emotional functioning. The range of score is 0-100; higher score = better functioning. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Fatigue | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures fatigue. The range of score is 0-100; higher score = better functioning. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Cognitive Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures cognitive functioning. The range of score is 0-100; higher score = better functioning. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Nausea/Vomiting | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures nausea and vomiting The range of score is 0-100; higher score = better functioning. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Pain | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures pain. The range of score is 0-100; higher score = better functioning. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Social Functioning | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures social functioning. The range of score is 0-100; higher score = better functioning. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Dyspnea | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure dyspnea. The range of score is 0-100; higher score = higher symptoms burden. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Insomnia | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure insomnia. The range of score is 0-100; higher score = better functioning. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Appetite Loss | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure appetite loss The range of score is 0-100; higher score = higher symptoms burden. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Constipation | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure constipation. The range of score is 0-100; higher score = higher symptoms burden. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Diarrhea | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure diarrhea. The range of score is 0-100; higher score = higher symptoms burden. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Change in Quality of Life: Financial Difficulties | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure financial difficulties. The range of score is 0-100; higher score = higher symptoms burden. | Posted | Least Squares Mean | Standard Error | units on a scale | change from pre- to post-intervention (week 12) |
|
|
|
|
| Secondary | Moderate Aerobic Exercise | The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes. | A 12 week outcome was not available for one subject in the control group. | Posted | Mean | Standard Deviation | Minutes of activity per week | baseline to 12 weeks |
|
|
|
| Secondary | Vigorous Aerobic Exercise | The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes. | A 12 week outcome was not available for one subject in the control group. | Posted | Mean | Standard Deviation | Minutes of activity per week | baseline to 12 weeks |
|
|
|
| Secondary | Change in C-reactive Protein (CRP) | The investigators will obtain serum CRP, a marker of inflammation. | Only n=10 patients provided baseline and follow-up samples; 6 in the intervention group and 4 in the control group. | Posted | Mean | Standard Deviation | ng/mL | change from pre- to post-intervention (week 12) |
|
|
|
| Secondary | Change in Leptin Level | The investigators will obtain serum leptin, a marker of glucose control. . | Only n=10 patients provided baseline and follow-up samples; 6 in the intervention group and 4 in the control group. | Posted | Mean | Standard Deviation | ng/mL | change from pre- to post-intervention (week 12) |
|
|
|
| Secondary | Change in Insulin Level | The investigators will obtain serum insulin level, a measure of glucose control. | Only n=10 patients provided baseline and follow-up samples; 6 in the intervention group and 4 in the control group. | Posted | Mean | Standard Deviation | uIU/mL | change from pre- to post-intervention (week 12) |
|
|
|
| Secondary | Programmed Death - Ligand | The investigators will collect soluble PD- L1, a novel cancer marker. | Only n=10 patients provided baseline and follow-up samples; 6 in the intervention group and 4 in the control group. | Posted | Mean | Standard Deviation | pg/mL | change from pre- to post-intervention (week 12) |
|
|
|
| Secondary | Programmed Cell Death (PD-1) | The investigators will collect soluble PD- 1, a novel cancer marker. | Only n=10 patients provided baseline and follow-up samples; 6 in the intervention group and 4 in the control group. | Posted | Mean | Standard Deviation | pg/mL | change from pre- to post-intervention (week 12) |
|
|
|
| 0 |
| 20 |
| 3 |
| 20 |
| 2 |
| 20 |
| EG001 | Control Group | Usual care group will receive standard of care management from their Oncologist. | 0 | 20 | 1 | 20 | 0 | 20 |
| hyperthyroidism | Endocrine disorders | Systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ankle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| 12 weeks |
|
|
| 12 weeks |
|
|