Clinical trial NCT04788264: Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Carcinoma
Hypopharyngeal Carcinoma
Laryngeal Carcinoma
Maxillary Sinus Carcinoma
Oral Cavity Carcinoma
Oropharyngeal Carcinoma
Paranasal Sinus Carcinoma
Sinonasal Carcinoma
Stage I Laryngeal Cancer AJCC v8
Stage II Laryngeal Cancer AJCC v8
Stage III Laryngeal Cancer AJCC v8
Stage IV Laryngeal Cancer AJCC v8
Stage IVA Laryngeal Cancer AJCC v8
Stage IVB Laryngeal Cancer AJCC v8
Stage IVC Laryngeal Cancer AJCC v8
Lung Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: PRIMARY OBJECTIVE:

I. To compare the changes in physical activity between the control and intervention groups of patients with head and neck or lung cancer at 6-weeks and 12-weeks, compared to baseline.

SECONDARY OBJECTIVES:

I. To demonstrate the feasibility, engagement, retention, and acceptability of physical activity promotion (intervention) in patients with head and neck or lung cancer.

II. To calculate the effect sizes for the differences between the control and intervention in daily changes in psychosocial outcomes at 6-weeks and 12-weeks, compared to baseline.

EXPLORATORY OBJECTIVE:

I. To calculate the effect sizes for the differences between the control and intervention in changes in immunomodulatory, metabolic and aging biomarkers at 6-weeks and 12-weeks, compared to baseline.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Beginning 1 week prior to start of intervention, patients receive a Fitbit to monitor physical activity for 13 weeks. Patients receive consultation and personalized exercise prescription from a physical therapist at baseline, and attend exercise training sessions with a physical therapist during weeks 1, 3, 6, 9, and 12. Patients also attend behavior modification sessions with a behavioral therapist that focus on goal setting and healthy behavior changes during weeks 2, 4, 5, 7, 8, 10, and 11.

ARM II: Patients receive a Fitbit to monitor physical activity for 12 weeks. Patients also receive consultation from a physical therapist to assess physical performance at weeks 1, 6, and 12.

After completion of study intervention, patients are followed up at 30 days.

EXPLORATORY OBJECTIVE:

I. To demonstrate the difference in the magnitude of physical activity improvements between the immunotherapy and chemo-immunotherapy patients.

OUTLINE:

Beginning 1 week prior to start of intervention, patients receive a Fitbit to monitor physical activity for 13 weeks. Patients receive consultation and personalized exercise prescription from a physical therapist at baseline, and attend exercise training sessions with a physical therapist during weeks 1, 3, 6, 9, and 12. Patients also attend behavior modification sessions with a behavioral therapist that focus on goal setting and healthy behavior changes during weeks 2, 4, 5, 7, 8, 10, and 11.

After completion of study intervention, patients are followed up at 30 days.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
timeFrame: Baseline to 12 weeks after physical activity promotion
measure: Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
timeFrame: Baseline to 12 weeks after physical activity promotion
measure: Change in Fitbit-recorded average active minutes (moderate and/or intensive) per day, each day
timeFrame: Baseline to 12 weeks after physical activity promotion
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: