Head and Neck Carcinoma Clinical Trial
Official title:
A Pilot Study to Assess Feasibility of a Clinically Significant Increase in Physical Activity in Patients With Head and Neck Cancer Undergoing Active Treatment
NCT number | NCT04788264 |
Other study ID # | 20D.775 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 28, 2021 |
Est. completion date | June 29, 2023 |
Verified date | November 2023 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | June 29, 2023 |
Est. primary completion date | June 29, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day | Changes in physical activity of the intervention group at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models | Baseline to 12 weeks after physical activity promotion | |
Primary | Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day | Changes in physical activity of the control group at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models | Baseline to 12 weeks after physical activity promotion | |
Primary | Change in Fitbit-recorded average active minutes (moderate and/or intensive) per day, each day | time trend will be compared between control and intervention groups at 6-weeks and 12-weeks, compared to baseline, using two-sample t-tests, respectively. Longitudinal models such as (non)linear mixed models or generalized estimating equation (GEE) models | Baseline to 12 weeks after physical activity promotion |
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