Pilot Study of the Haymakers for Hope Fitness Program

NCT ID: NCT04220216

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2022-01-18

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..

Conditions

Cancer; Exercise Test; Fatigue; Mood; Quality of Life; Biomarkers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

H4H fitness program

Intervention Type: OTHER

4 weekly, 1 hour exercise sessions

Interventions

H4H fitness program

4 weekly, 1 hour exercise sessions

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haymakers for Hope

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth O'Donnell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth O'Donnell, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

19-426

Identifier Type: -

Identifier Source: org_study_id