Pilot Study of the Haymakers for Hope Fitness Program

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

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

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Cancer; Fatigue; Biomarkers; Mood; Exercise Test
• Intervention / Treatment: Other: H4H fitness 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..

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: H4H fitness program; 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; 4 weekly, 1 hour exercise sessions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Haymakers for Hope
• Investigators: Principal Investigator: Elizabeth O'Donnell, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Quality of Life; Fatigue; Biomarkers; Mood; Cardiopulmonary Exercise Test; Exercise Test; Analysis, Survival
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 19-426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No