Clinical trial NCT04220216: 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
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Haymakers for Hope
First posted: 2020-01-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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..

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

Primary outcomes:
measure: Rate of Attendance
timeFrame: 16 weeks
measure: Rate of Completion
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in cardiopulmonary fitness as assessed by the 6-minute walk test
timeFrame: 16 weeks
measure: Change in strength
timeFrame: 16 weeks
measure: Change in QOL as assessed by the Functional Assessment of Cancer Therapy - General
timeFrame: 16 weeks
measure: 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)
timeFrame: 16 weeks
measure: Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue
timeFrame: 16 weeks
measure: 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)
timeFrame: 16 weeks
measure: Change in anxiety as assessed by Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety)
timeFrame: 16 weeks
measure: Change in depression as assessed by Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more depression)
timeFrame: 16 weeks
measure: 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.
timeFrame: 16 weeks
measure: Change in physical activity level as assessed using the using the Godin Leisure-Time Exercise Questionnaire.
timeFrame: 16 weeks
measure: Change in lipid profile
timeFrame: 16 weeks
measure: Change in hemoglobin A1c (%)
timeFrame: 16 weeks
measure: Change in c-reactive protein (mg/L)
timeFrame: 16 weeks
measure: Change in interleukin-6 (pg/mL)
timeFrame: 16 weeks
measure: Change in tumor necrosis factor alpha (pg/mL)
timeFrame: 16 weeks
measure: Change in insulin (mcU/mL)
timeFrame: 16 weeks
measure: Change in leptin (ng/mL)
timeFrame: 16 weeks
measure: Change in adiponectin level (microgram/mL)
timeFrame: 16 weeks
measure: Change in insulin-like growth factor (ng/mL)
timeFrame: 16 weeks
measure: Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth O'Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References: