A Pilot Study to Assess the Haymakers for Hope Fitness Program in Cancer Survivors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Rate of Attendance
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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..
Investigators
Elizabeth O'Donnell
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of Attendance
Time Frame: 16 weeks
Participants will be considered to have completed the fitness program if they attend at least 70% of the sessions
Rate of Completion
Time Frame: 16 weeks
Feasibility will be demonstrated if ≥60% of participants complete the fitness program
Secondary Outcomes
- Change in QOL as assessed by the Functional Assessment of Cancer Therapy - General(16 weeks)
- Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue(16 weeks)
- Change in leptin (ng/mL)(16 weeks)
- Change in cardiopulmonary fitness as assessed by the 6-minute walk test(16 weeks)
- Change in strength(16 weeks)
- Change in lipid profile(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)(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.(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)(16 weeks)
- Change in interleukin-6 (pg/mL)(16 weeks)
- Change in tumor necrosis factor alpha (pg/mL)(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)(16 weeks)
- Change in physical activity level as assessed using the using the Godin Leisure-Time Exercise Questionnaire.(16 weeks)
- Change in hemoglobin A1c (%)(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)(16 weeks)
- Change in adiponectin level (microgram/mL)(16 weeks)
- Change in c-reactive protein (mg/L)(16 weeks)
- Change in insulin (mcU/mL)(16 weeks)
- Change in insulin-like growth factor (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)(16 weeks)