Hematopoietic and Lymphoid Cell Neoplasm
Conditions
Keywords
Hematologic Malignancy, Exercise, Decreased Physical Activity
Brief summary
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.
Detailed description
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: * Cancer and Aging Research Group (CARG) Geriatric Assessment Tool parameters. * Change in Short Physical Performance Battery (SPPB). * Number and severity of falls. * Impact of motivation and self-efficacy on adherence. * Hospital readmission rates (if applicable). * Length of inpatient stays (if applicable). * Patient Reported Outcome Measurement Information System (PROMIS) for Health related quality of life (HRQL). * Correlative analysis of peripheral blood biomarkers of aging and inflammation (cyclin-dependent kinase inhibitor 2A \[p16\], inflammatory biomarkers, immunosenescence, micro \[mi\] ribonucleic acid \[RNA\]). 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.
Interventions
BEHAVIORALExercise Intervention
Complete individualized exercise program
OTHERLaboratory Biomarker Analysis
Correlative studies
PROCEDUREPhysical Therapy
Complete individualized exercise program
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with hematologic malignancy receiving care (chemotherapy, immunotherapy, targeted agents, bone marrow transplant, or other) for their hematologic malignancy at the Ohio State University * Impairments in physical function, as defined by a score \< 9 on the SPPB pre-screen * Medical clearance from an oncologist or primary care physician stating the participant is able to participate in an unsupervised, moderate-intensity physical activity program * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Prisoners * Any medical condition including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0 | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) | 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. |
| Percentage of Eligible Patients Completing the OEP | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS) | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) | 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. |
| Health Related Quality of Life (HRQL) Measured Using the PROMIS | Study visit 1 (Baseline), Study visit 2 (month 4), and study visit 3 (month 6, completion of study) | 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. |
| Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) | 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. |
| Number of Falls (Inpatient and Outpatient) | Up to 6 months | The total number of falls experienced by participants will be reported. Both falls that occur inpatient and outpatient will be included. |
| Biomarker Expression Levels | Study Visit 1 (Baseline), and study visit 3 (6 months) | 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. |
| Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) | 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 |
| Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant | At 90 days | Evaluating the frequency (percentage of patients with hospital re-admissions) within 90 days |
| Length of Inpatient Stays for Patients Undergoing Transplant | Up to 6 months | 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. |
| Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB) | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) | 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 |
| 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 | Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months) | 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. |
Countries
United States
Participant flow
Recruitment details
Potential participants were recruited from the hematology clinics at The Ohio State University Comprehensive Cancer Center August 2016 to January 2018.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Supportive Care (Otago Exercise Programme) |
|---|---|
| Age, Customized | 75.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care (Otago Exercise Programme) | Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0 | 0 Participants |
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
Time frame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supportive Care (Otago Exercise Programme) | Percentage of Eligible Patients Completing the OEP | 66.7 percent of patients |
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.
Time frame: Study Visit 1 (Baseline), and study visit 3 (6 months)
Population: number analyzed is the number of patients that fit into each category: unfavorable, mid, and favorable.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Otago Exercise Programme) | Biomarker Expression Levels | KIR_Activating _Subgroup_1 Unfavorable median | 1.26 cycle threshold |
| Supportive Care (Otago Exercise Programme) | Biomarker Expression Levels | KIR_Activating _Subgroup_1 Mid median | -0.19 cycle threshold |
| Supportive Care (Otago Exercise Programme) | Biomarker Expression Levels | KIR_Activating _Subgroup_1 Favorable median | 0.15 cycle threshold |
| Supportive Care (Otago Exercise Programme) | Biomarker Expression Levels | KIR_Activating_Subgroup_2 Unfavorable median | 0.62 cycle threshold |
| Supportive Care (Otago Exercise Programme) | Biomarker Expression Levels | KIR_Activating _Subgroup_2 Mid median | -0.05 cycle threshold |
| Supportive Care (Otago Exercise Programme) | Biomarker Expression Levels | KIR_Activating _Subgroup_2 Favorable median | 0.20 cycle threshold |
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.
Time frame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Population: only 7 patients had transplants
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Otago Exercise Programme) | 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 | Visit 1 | 80 score on a scale |
| Supportive Care (Otago Exercise Programme) | 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 | Visit 2 | 85 score on a scale |
| Supportive Care (Otago Exercise Programme) | 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 | Visit 3 | 90 score on a scale |
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.
Time frame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Population: Patients did not complete all visits
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Otago Exercise Programme) | Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS) | Visit 1 | 80 score on a scale |
| Supportive Care (Otago Exercise Programme) | Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS) | Visit 2 | 90 score on a scale |
| Supportive Care (Otago Exercise Programme) | Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS) | Visit 3 | 90 score on a scale |
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.
Time frame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Population: only 7 patients received transplants
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Otago Exercise Programme) | Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant | Visit 1 | 34.9 score on a scale |
| Supportive Care (Otago Exercise Programme) | Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant | Visit 2 | 36.2 score on a scale |
| Supportive Care (Otago Exercise Programme) | Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant | Visit 3 | 34.9 score on a scale |
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
Time frame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Population: Patients did not complete all visits
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Otago Exercise Programme) | Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB) | Visit 1 | 7 units on a scale |
| Supportive Care (Otago Exercise Programme) | Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB) | Visit 2 | 11 units on a scale |
| Supportive Care (Otago Exercise Programme) | Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB) | Visit 3 | 9 units on a scale |
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
Time frame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Population: only 7 patients received transplant
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Otago Exercise Programme) | Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant | Visit 1 | 8 units on a scale |
| Supportive Care (Otago Exercise Programme) | Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant | Visit 2 | 11.5 units on a scale |
| Supportive Care (Otago Exercise Programme) | Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant | Visit 3 | 10 units on a scale |
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.
Time frame: Study visit 1 (Baseline), Study visit 2 (month 4), and study visit 3 (month 6, completion of study)
Population: Patients did not complete all visits
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supportive Care (Otago Exercise Programme) | Health Related Quality of Life (HRQL) Measured Using the PROMIS | Visit 1 | 32.4 score on a scale |
| Supportive Care (Otago Exercise Programme) | Health Related Quality of Life (HRQL) Measured Using the PROMIS | Visit 2 | 34.9 score on a scale |
| Supportive Care (Otago Exercise Programme) | Health Related Quality of Life (HRQL) Measured Using the PROMIS | Visit 3 | 36.2 score on a scale |
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.
Time frame: Up to 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supportive Care (Otago Exercise Programme) | Length of Inpatient Stays for Patients Undergoing Transplant | 18 days |
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.
Time frame: Up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supportive Care (Otago Exercise Programme) | Number of Falls (Inpatient and Outpatient) | 3 number of falls |
Secondary
Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant
Evaluating the frequency (percentage of patients with hospital re-admissions) within 90 days
Time frame: At 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supportive Care (Otago Exercise Programme) | Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant | 42.9 percentage of patients |