Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head an… (NCT04788264) | Clinical Trial Compass
CompletedNot Applicable
Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment
United States12 participantsStarted 2021-03-28
Plain-language summary
This clinical trial evaluates the tolerability of a physical activity program in head and neck cancer patients who are undergoing cancer treatment. The goal of this trial is to give patients exercises prescribed by a physical therapist that they are able to complete regularly at home. Increasing physical activity may help patients reduce fatigue, improve mood, increase physical performance, and decrease joint pain.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with head and neck cancer including cancers of the sinuses, oral cavity, oropharynx, hypopharynx, or larynx (all stages); therapeutically eligible to receive at least three months of immunotherapy
* Medically cleared by oncologist to engage in aerobic and resistance exercise intervention
* 18 years of age or older
* Access to a smartphone and have an active wi-fi connection at home
* Able to read and/or to speak English
* Able to comprehend and sign a written informed consent (no cognitive decline)
* Women of reproductive potential must have a negative serum or urine pregnancy test within the week prior to starting therapy
Exclusion Criteria:
* Severe or unstable cardiopulmonary, metabolic, or renal disease as determined by the referring oncologist
* Unable to walk safely without physical assistance of another person
* Any condition that may limit the ability to comply with behavioral recommendations of the program
* Pregnant or planning a pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
Timeframe: Baseline to 12 weeks after physical activity promotion
2
Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
Timeframe: Baseline to 12 weeks after physical activity promotion
3
Change in Fitbit-recorded average active minutes (moderate and/or intensive) per day, each day
Timeframe: Baseline to 12 weeks after physical activity promotion