Pilot Study of the Haymakers for Hope Fitness Program

NCT04220216 | Terminated DMC

• 1 other identifier: 19-426
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Cancer; Exercise Test; Cardiopulmonary Exercise Test; Fatigue; Mood; Quality of Life; Biomarkers; Analysis, Survival

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Change in cardiopulmonary fitness as assessed by the 6-minute walk test

  16 weeks

• Change in strength

  16 weeks

• Change in QOL as assessed by the Functional Assessment of Cancer Therapy - General

  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 fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue

  16 weeks

Study Arms (1)

H4H fitness program

EXPERIMENTAL

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

Interventions

H4H fitness program OTHER

4 weekly, 1 hour exercise sessions

H4H fitness program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Haymakers for Hope: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth O'Donnell, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 7, 2020
• Study Start: February 20, 2020
• Primary Completion: March 12, 2020
• Study Completion: January 18, 2022
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)