Pilot Study of the Haymakers for Hope Fitness Program

Study Overview
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Brief Summary
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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

Detailed Description
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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. This 16 week will include supervised exercises designed to improve strength, flexibility, balance and cardiopulmonary fitness. There will be 4 sessions of 1 hour each week for each of the 10 participants. The program will be conducted at gymnasiums contracted with the H4H program and outcomes assessments at Massachusetts General Hospital and the gymnasiums..

Official Title
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A Pilot Study to Assess the Haymakers for Hope Fitness Program in Cancer Survivors

Conditions
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Cancer, Exercise Test, Fatigue, Mood, Quality of Life, Biomarkers

Intervention / Treatment
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* Other: H4H fitness program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer diagnosis excluding non-melanoma skin cancer Age ≥ 18 years ECOG performance status ≤1 Medical clearance by treating clinician No known contraindications to moderate intensity exercise such as (but not limited to) brain metastases, serious or non-healing wound, peripheral neuropathy greater than or equal to Grade 3, or myocardial infarction within 1- year. Able to complete forms and understand instruction in English Willing and able to attend the H4H program for 16 weeks Willing and able to complete the baseline and follow-up visits at MGH Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Participants who have had surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to surgery more than 4 weeks earlier. Blastic or lytic bone lesions Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Chest pain brought on by physical activity Pregnant women or women intending to become pregnant during the study period Presence of dementia or major psychiatric illness that would preclude participation in a group program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H4H fitness program<br>The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Patients will attend the 16-week program of boxing conditioning. This 16-week program will include supervised exercises designed to improve strength, flexibility, balance,and cardiopulmonary fitness. There will be 4, 1-hour sessions each week per participant | Other: H4H fitness program<br>* 4 weekly, 1 hour exercise sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Exercise Test, Cardiopulmonary Exercise Test, Fatigue, Mood, Quality of Life, Biomarkers, Analysis, Survival