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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00446 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This pilot trial studies a structured exercise program intervention in improving physical activity in older patients with hematologic malignancies undergoing cancer therapy. Patients with hematologic malignancies are at an increased risk of functional dependence and injury. Structured exercise programs, such as the Otago exercise programme (OEP), may improve balance, strength, and prevent fall-related injury in older patients with hematologic malignancies undergoing cancer therapy.
PRIMARY OBJECTIVES:
I. To assess the feasibility of implementing a structured exercise program by evaluating recruitment and retention, exercise program adherence, sustainability, adverse events, and implementation challenge.
SECONDARY OBJECTIVES:
I. To calculate preliminary effect sizes of the impact of an exercise program in patients with hematologic malignancy undergoing therapy, as measured by:
OUTLINE:
Patients attend 8 physical therapy visits twice monthly for 4 months or until transplant. Patients also undergo an individualized exercise program at home for 6 months. The program comprises 3 main components: walking over 30 minutes twice a week, strengthening and balance retraining exercise over 30 minutes three times a week.
After completion of study, patients are followed up at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (otago exercise programme) | Experimental | Patients attend 8 physical therapy visits twice monthly for 4 months or until transplant. Patients also undergo an individualized exercise program at home for 6 months. The program comprises 3 main components: walking over 30 minutes twice a week, strengthening and balance retraining exercise over 30 minutes three times a week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Complete individualized exercise program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0 | Adverse Events and their severity will be captured and graded according to Common Terminology Criteria for Adverse Events Version 5.0, and whether any events can be attributed to exercise. | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
| Percentage of Eligible Patients Completing the OEP | Feasibility defined as 80% of eligible of patients completing the OEP. The proportion of screened patients who agree to participate, the proportion of patients who attend certain percentage of assigned physical therapy (PT) sessions and the proportion of patients who complete the whole study along will be described with respective 95% confidence intervals. Study implementation and challenges will be evaluated by patient exercise logs. Exercise levels at home will also be assessed by exercise diary log | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker Expression Levels | Specific biomarkers of aging will be explored to determine a relationship with molecular markers of aging and epigenetic age with a frailty phenotype. mRNA isolates will be analyzed using a nanostring codeset. The regulation levels of killer cell immunoglobulin-like receptors (KIRs) will be reported. Both KIR_Activating_Subgroup_1 and KIR_Activating_Subgroup_2 levels will be reported. Participants are classified based on a frailty scale: favorable (fit patients based on frailty scale), mid (intermediately fit), unfavorable (frail). Negative values indicate a downregulation of gene expression and positive values indicate an upregulation of gene expression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Rosko, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34446377 | Derived | Rosko A, Huang Y, Jones D, Presley CJ, Jaggers J, Owens R, Naughton M, Krok-Schoen JL. Feasibility of implementing an exercise intervention in older adults with hematologic malignancy. J Geriatr Oncol. 2022 Mar;13(2):234-240. doi: 10.1016/j.jgo.2021.07.010. Epub 2021 Aug 24. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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Potential participants were recruited from the hematology clinics at The Ohio State University Comprehensive Cancer Center August 2016 to January 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Supportive Care (Otago Exercise Programme) | Patients attend 8 physical therapy visits twice monthly for 4 months or until transplant. Patients also undergo an individualized exercise program at home for 6 months. The program comprises 3 main components: walking over 30 minutes twice a week, strengthening and balance retraining exercise over 30 minutes three times a week. Exercise Intervention: Complete individualized exercise program Laboratory Biomarker Analysis: Correlative studies Physical Therapy: Complete individualized exercise program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Supportive Care (Otago Exercise Programme) | Patients attend 8 physical therapy visits twice monthly for 4 months or until transplant. Patients also undergo an individualized exercise program at home for 6 months. The program comprises 3 main components: walking over 30 minutes twice a week, strengthening and balance retraining exercise over 30 minutes three times a week. Exercise Intervention: Complete individualized exercise program Laboratory Biomarker Analysis: Correlative studies Physical Therapy: Complete individualized exercise program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0 | Adverse Events and their severity will be captured and graded according to Common Terminology Criteria for Adverse Events Version 5.0, and whether any events can be attributed to exercise. | Posted | Count of Participants | Participants | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
|
Adverse event information was collected for patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion an average of 1 year.
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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 | Supportive Care (Otago Exercise Programme) | Patients attend 8 physical therapy visits twice monthly for 4 months or until transplant. Patients also undergo an individualized exercise program at home for 6 months. The program comprises 3 main components: walking over 30 minutes twice a week, strengthening and balance retraining exercise over 30 minutes three times a week. Exercise Intervention: Complete individualized exercise program Laboratory Biomarker Analysis: Correlative studies Physical Therapy: Complete individualized exercise program Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashley Rosko | The Ohio State University Comprehensive Cancer Center | 614-293-3196 | Ashley.Rosko@osumc.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 | Jul 30, 2019 | Feb 7, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2016 | Aug 31, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Physical Therapy | Procedure | Complete individualized exercise program |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Study Visit 1 (Baseline), and study visit 3 (6 months) |
| Change in Geriatric Assessment (GA) Measured Using The Cancer and Aging Research Group (CARG) Geriatric Assessment (G)A-patient Reported Karnofsky Performance Status (KPS) for Patients Undergoing Transplant | Patient-reported KPS31 measures the patients self-reported level of physical function. Scoring extends from 30 (severely disabled) - 100 (normal), with a higher score indicating a higher level of physical function. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
| Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS) | Patient-reported KPS31 measures the patients self-reported level of physical function. Scoring extends from 30 (severely disabled) - 100 (normal), with a higher score indicating a higher level of physical function. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
| Health Related Quality of Life (HRQL) Measured Using the PROMIS | Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale Short Form v1.1 HRQL measures provide information to the clinician regarding the patient experience of treatment or intervention. The PROMIS Global Health Scale has been rigorously tested for reliability and validity and can be applied to all populations, where higher scores reflect improved quality of life. It consists of 10 questions and was given to the patients for self-administration at three intervals. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. 5 point Likert scale higher values represent a better quality of life. PROMIS scores, developed by the NIH, are usually presented as T-scores, where the average score is 50 and a standard deviation is 10. | Study visit 1 (Baseline), Study visit 2 (month 4), and study visit 3 (month 6, completion of study) |
| Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant | Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale Short Form v1.1 HRQL measures provide information to the clinician regarding the patient experience of treatment or intervention. The PROMIS Global Health Scale has been rigorously tested for reliability and validity and can be applied to all populations, where higher scores reflect improved quality of life. It consists of 10 questions and was given to the patients for self-administration at three intervals. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. 5 point Likert scale higher values represent a better quality of life. PROMIS scores, developed by the NIH, are usually presented as T-scores, where the average score is 50 and a standard deviation is 10. | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
| Number of Falls (Inpatient and Outpatient) | The total number of falls experienced by participants will be reported. Both falls that occur inpatient and outpatient will be included. | Up to 6 months |
| Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB) | Scores are assigned for each of the tests and an aggregate score is assigned ranging from 0-12, with higher scores indicating greater physical function. SPPB scores are classified into 4 categories: very low physical function (0-3); low physical function (4-6); moderate physical function (7-9) and high physical function (10-12). An alpha internal consistency of 0.76 has been reported | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
| Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant | Scores are assigned for each of the tests and an aggregate score is assigned ranging from 0-12, with higher scores indicating greater physical function. SPPB scores are classified into 4 categories: very low physical function (0-3); low physical function (4-6); moderate physical function (7-9) and high physical function (10-12). An alpha internal consistency of 0.76 has been reported | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
| Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant | Evaluating the frequency (percentage of patients with hospital re-admissions) within 90 days | At 90 days |
| Length of Inpatient Stays for Patients Undergoing Transplant | Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. The proportion of patients who achieve meaningful change in these scores will be described with 95% confidence intervals. Difference from baseline will be tested with Wilcoxon signed rank test or McNemar's test for continuous or categorical variables respectively. | Up to 6 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Percentage of Eligible Patients Completing the OEP | Feasibility defined as 80% of eligible of patients completing the OEP. The proportion of screened patients who agree to participate, the proportion of patients who attend certain percentage of assigned physical therapy (PT) sessions and the proportion of patients who complete the whole study along will be described with respective 95% confidence intervals. Study implementation and challenges will be evaluated by patient exercise logs. Exercise levels at home will also be assessed by exercise diary log | Posted | Number | percent of patients | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
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| Secondary | Biomarker Expression Levels | Specific biomarkers of aging will be explored to determine a relationship with molecular markers of aging and epigenetic age with a frailty phenotype. mRNA isolates will be analyzed using a nanostring codeset. The regulation levels of killer cell immunoglobulin-like receptors (KIRs) will be reported. Both KIR_Activating_Subgroup_1 and KIR_Activating_Subgroup_2 levels will be reported. Participants are classified based on a frailty scale: favorable (fit patients based on frailty scale), mid (intermediately fit), unfavorable (frail). Negative values indicate a downregulation of gene expression and positive values indicate an upregulation of gene expression. | number analyzed is the number of patients that fit into each category: unfavorable, mid, and favorable. | Posted | Median | Full Range | cycle threshold | Study Visit 1 (Baseline), and study visit 3 (6 months) |
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| Secondary | Change in Geriatric Assessment (GA) Measured Using The Cancer and Aging Research Group (CARG) Geriatric Assessment (G)A-patient Reported Karnofsky Performance Status (KPS) for Patients Undergoing Transplant | Patient-reported KPS31 measures the patients self-reported level of physical function. Scoring extends from 30 (severely disabled) - 100 (normal), with a higher score indicating a higher level of physical function. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. | only 7 patients had transplants | Posted | Median | Full Range | score on a scale | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
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| Secondary | Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS) | Patient-reported KPS31 measures the patients self-reported level of physical function. Scoring extends from 30 (severely disabled) - 100 (normal), with a higher score indicating a higher level of physical function. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. | Patients did not complete all visits | Posted | Median | Full Range | score on a scale | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
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| Secondary | Health Related Quality of Life (HRQL) Measured Using the PROMIS | Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale Short Form v1.1 HRQL measures provide information to the clinician regarding the patient experience of treatment or intervention. The PROMIS Global Health Scale has been rigorously tested for reliability and validity and can be applied to all populations, where higher scores reflect improved quality of life. It consists of 10 questions and was given to the patients for self-administration at three intervals. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. 5 point Likert scale higher values represent a better quality of life. PROMIS scores, developed by the NIH, are usually presented as T-scores, where the average score is 50 and a standard deviation is 10. | Patients did not complete all visits | Posted | Median | Full Range | score on a scale | Study visit 1 (Baseline), Study visit 2 (month 4), and study visit 3 (month 6, completion of study) |
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| Secondary | Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant | Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale Short Form v1.1 HRQL measures provide information to the clinician regarding the patient experience of treatment or intervention. The PROMIS Global Health Scale has been rigorously tested for reliability and validity and can be applied to all populations, where higher scores reflect improved quality of life. It consists of 10 questions and was given to the patients for self-administration at three intervals. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. 5 point Likert scale higher values represent a better quality of life. PROMIS scores, developed by the NIH, are usually presented as T-scores, where the average score is 50 and a standard deviation is 10. | only 7 patients received transplants | Posted | Median | Full Range | score on a scale | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
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| Secondary | Number of Falls (Inpatient and Outpatient) | The total number of falls experienced by participants will be reported. Both falls that occur inpatient and outpatient will be included. | Posted | Number | number of falls | Up to 6 months |
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| Secondary | Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB) | Scores are assigned for each of the tests and an aggregate score is assigned ranging from 0-12, with higher scores indicating greater physical function. SPPB scores are classified into 4 categories: very low physical function (0-3); low physical function (4-6); moderate physical function (7-9) and high physical function (10-12). An alpha internal consistency of 0.76 has been reported | Patients did not complete all visits | Posted | Median | Full Range | units on a scale | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
|
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| Secondary | Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant | Scores are assigned for each of the tests and an aggregate score is assigned ranging from 0-12, with higher scores indicating greater physical function. SPPB scores are classified into 4 categories: very low physical function (0-3); low physical function (4-6); moderate physical function (7-9) and high physical function (10-12). An alpha internal consistency of 0.76 has been reported | only 7 patients received transplant | Posted | Median | Full Range | units on a scale | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) |
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| Secondary | Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant | Evaluating the frequency (percentage of patients with hospital re-admissions) within 90 days | Posted | Number | percentage of patients | At 90 days |
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| Secondary | Length of Inpatient Stays for Patients Undergoing Transplant | Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. The proportion of patients who achieve meaningful change in these scores will be described with 95% confidence intervals. Difference from baseline will be tested with Wilcoxon signed rank test or McNemar's test for continuous or categorical variables respectively. | Posted | Median | Full Range | days | Up to 6 months |
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| D001519 |
| Behavior |
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| KIR_Activating _Subgroup_1 Favorable median |
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| KIR_Activating_Subgroup_2 Unfavorable median |
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| KIR_Activating _Subgroup_2 Mid median |
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| KIR_Activating _Subgroup_2 Favorable median |
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