CancerNCT04220216
Pilot Study of the Haymakers for Hope Fitness Program
A study testing H4H fitness program in people with Cancer and Exercise Test, run by Massachusetts General Hospital at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Exercise Test, Fatigue
- What is being tested?
- H4H fitness program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to 18 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
Official title: 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
Read the 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
- Being tested
- H4H fitness program
- Keywords
- Cancer, Exercise Test, Cardiopulmonary Exercise Test, Fatigue, Mood, Quality of Life, Biomarkers, Analysis, Survival
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H4H fitness programOther
4 weekly, 1 hour exercise sessions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: H4H fitness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Attendance
Participants will be considered to have completed the fitness program if they attend at least 70% of the sessions
Measured: 16 weeks
Rate of Completion
Feasibility will be demonstrated if ≥60% of participants complete the fitness program
Measured: 16 weeks
Secondary outcomes (20)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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%)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start20 Feb 2020
- Primary completion12 Mar 2020
- Study completion18 Jan 2022
Why it stopped: COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haymakers for Hope
- Responsible party
- Principal investigator, Elizabeth O'Donnell, Massachusetts General Hospital
- Investigators
- Elizabeth O'Donnell, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220216
- Sponsor's protocol ID
- 19-426
- Status last verified
- Jan 2022
- First submitted
- 19 Dec 2019
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Haymakers for Hope Fitness Program in Cancer Survivors
- ClinicalTrials.gov ID
- NCT04220216
- Acronym / sponsor ID
- 19-426
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID pandemic
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Haymakers for Hope
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H4H fitness program | Experimental | Other: H4H fitness programThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H4H fitness program4 weekly, 1 hour exercise sessions | Other | H4H fitness program |
Primary outcome
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
20 secondary outcomes
Change in cardiopulmonary fitness as assessed by the 6-minute walk test
Time frame: 16 weeks
Change in strength
Time frame: 16 weeks
Change in QOL as assessed by the Functional Assessment of Cancer Therapy - General
Time frame: 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)
Time frame: 16 weeks
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 16 weeks
Change in physical activity level as assessed using the using the Godin Leisure-Time Exercise Questionnaire.
Time frame: 16 weeks
Change in lipid profile
Time frame: 16 weeks
Change in hemoglobin A1c (%)
Time frame: 16 weeks
Change in c-reactive protein (mg/L)
Time frame: 16 weeks
Change in interleukin-6 (pg/mL)
Time frame: 16 weeks
Change in tumor necrosis factor alpha (pg/mL)
Time frame: 16 weeks
Change in insulin (mcU/mL)
Time frame: 16 weeks
Change in leptin (ng/mL)
Time frame: 16 weeks
Change in adiponectin level (microgram/mL)
Time frame: 16 weeks
Change in insulin-like growth factor (ng/mL)
Time frame: 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)
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth O'Donnell, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H4H fitness program in people with Cancer and Exercise Test, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Attendance (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.