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Pilot Study of the Haymakers for Hope Fitness Program

Primary Purpose

Cancer, Exercise Test, Fatigue

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
H4H fitness program
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Cancer, Exercise Test, Cardiopulmonary Exercise Test, Fatigue, Mood, Quality of Life, Biomarkers, Analysis, Survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

H4H fitness program

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of Attendance
Participants will be considered to have completed the fitness program if they attend at least 70% of the sessions
Rate of Completion
Feasibility will be demonstrated if ≥60% of participants complete the fitness program

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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).
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%)
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)
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
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
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)
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)
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)
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)
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)

Full Information

First Posted
December 19, 2019
Last Updated
January 18, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Haymakers for Hope
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1. Study Identification

Unique Protocol Identification Number
NCT04220216
Brief Title
Pilot Study of the Haymakers for Hope Fitness Program
Official Title
A Pilot Study to Assess the Haymakers for Hope Fitness Program in Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID pandemic
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
January 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Haymakers for Hope

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Exercise Test, Fatigue, Mood, Quality of Life, Biomarkers
Keywords
Cancer, Exercise Test, Cardiopulmonary Exercise Test, Fatigue, Mood, Quality of Life, Biomarkers, Analysis, Survival

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H4H fitness program
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
H4H fitness program
Intervention Description
4 weekly, 1 hour exercise sessions
Primary Outcome Measure Information:
Title
Rate of Attendance
Description
Participants will be considered to have completed the fitness program if they attend at least 70% of the sessions
Time Frame
16 weeks
Title
Rate of Completion
Description
Feasibility will be demonstrated if ≥60% of participants complete the fitness program
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in cardiopulmonary fitness as assessed by the 6-minute walk test
Description
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
Time Frame
16 weeks
Title
Change in strength
Description
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
Time Frame
16 weeks
Title
Change in QOL as assessed by the Functional Assessment of Cancer Therapy - General
Description
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
Time Frame
16 weeks
Title
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)
Description
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
Time Frame
16 weeks
Title
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue
Description
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
Time Frame
16 weeks
Title
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)
Description
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
Time Frame
16 weeks
Title
Change in anxiety as assessed by Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety)
Description
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
Time Frame
16 weeks
Title
Change in depression as assessed by Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more depression)
Description
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
Time Frame
16 weeks
Title
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.
Description
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
Time Frame
16 weeks
Title
Change in physical activity level as assessed using the using the Godin Leisure-Time Exercise Questionnaire.
Description
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
Time Frame
16 weeks
Title
Change in lipid profile
Description
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).
Time Frame
16 weeks
Title
Change in hemoglobin A1c (%)
Description
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%)
Time Frame
16 weeks
Title
Change in c-reactive protein (mg/L)
Description
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)
Time Frame
16 weeks
Title
Change in interleukin-6 (pg/mL)
Description
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
Time Frame
16 weeks
Title
Change in tumor necrosis factor alpha (pg/mL)
Description
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
Time Frame
16 weeks
Title
Change in insulin (mcU/mL)
Description
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)
Time Frame
16 weeks
Title
Change in leptin (ng/mL)
Description
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)
Time Frame
16 weeks
Title
Change in adiponectin level (microgram/mL)
Description
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)
Time Frame
16 weeks
Title
Change in insulin-like growth factor (ng/mL)
Description
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)
Time Frame
16 weeks
Title
Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population)
Description
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)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth O'Donnell, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study of the Haymakers for Hope Fitness Program

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