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COVID pandemic
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| Name | Class |
|---|---|
| Haymakers for Hope | UNKNOWN |
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This research study is assessing the effect of an exercise program on cancer survivors.
The exercise program is Haymakers for Hope 16-week exercise program
This is a pilot study, it is the first time investigators are examining the effect of this exercise program on cancer survivors physical and emotional functioning. The exercise programs is based on the conditioning program used by boxers.- Haymakers for Hope 16-week exercise program
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will attend the 16-week program of boxing conditioning. It is expected that about 10 people will take part in this research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H4H fitness program | Experimental | The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H4H fitness program | Other | 4 weekly, 1 hour exercise sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Attendance | Participants will be considered to have completed the fitness program if they attend at least 70% of the sessions | 16 weeks |
| Rate of Completion | Feasibility will be demonstrated if ≥60% of participants complete the fitness program | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiopulmonary fitness as assessed by the 6-minute walk test | summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences | 16 weeks |
| Change in strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth O'Donnell, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2019 | Apr 30, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
| 16 weeks |
| Change in QOL as assessed by the Functional Assessment of Cancer Therapy - General | summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences | 16 weeks |
| Change in psychological well-bring as assessed by the Ryff Psychological Well-Being Scale (Min score: 42, Max score: 252. A higher score indicating higher psychological well-being) | summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences | 16 weeks |
| Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue | summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences | 16 weeks |
| Change in sleep quality as assessed by the Rand Medical Outcome Survey (MOS) Sleep Scale (min score: 0; max score: 100. A higher core indicates more sleep problems) | summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences | 16 weeks |
| Change in anxiety as assessed by Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety) | summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences | 16 weeks |
| Change in depression as assessed by Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more depression) | summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences | 16 weeks |
| Change in body composition as assessed by change in total lean mass, extremity lean mass, total fat and trunk fat mass, as well as visceral adipose tissue mass which will be quantified using Hologic APEX 3.1 software. | summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences | 16 weeks |
| Change in physical activity level as assessed using the using the Godin Leisure-Time Exercise Questionnaire. | summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences | 16 weeks |
| Change in lipid profile | Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). (total cholesterol: mg/dL; triglycerides: mg/dL; high-density lipoprotein cholesterol mg/dL; low-density lipoprotein cholesterol mg/dL; very low-density lipoprotein cholesterol: mg/dL; cholesterol/HDL ratio mg/dL). | 16 weeks |
| Change in hemoglobin A1c (%) | Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), hemoglobin A1c reported as percentage of average blood sugar level (mg/dL or mmol/L), higher % corresponds to higher average blood sugar levels (normal A1C level is below 5.7%) | 16 weeks |
| Change in c-reactive protein (mg/L) | Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), mg/L (hs-CRP level of 1 mg/L or lower indicates low risk of CVD, hs-CRP level of 1-3 mg/L indicates moderate risk of CVD, hs-CRP level of greater than 3 mg/L indicates high risk of CVD) | 16 weeks |
| Change in interleukin-6 (pg/mL) | Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL | 16 weeks |
| Change in tumor necrosis factor alpha (pg/mL) | Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL | 16 weeks |
| Change in insulin (mcU/mL) | Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (mcU/mL) | 16 weeks |
| Change in leptin (ng/mL) | Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL) | 16 weeks |
| Change in adiponectin level (microgram/mL) | Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (microgram/mL) | 16 weeks |
| Change in insulin-like growth factor (ng/mL) | Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL) | 16 weeks |
| Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population) | Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). Plasma glucose: mmol/L (or mg/dL), Insulin: pmol/L (or microunits/mL) | 16 weeks |