Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment

A Pilot Study to Assess Feasibility of a Clinically Significant Increase in Physical Activity in Patients With Head and Neck Cancer Undergoing Active Treatment

Sponsors

Lead Sponsor: Thomas Jefferson University

Source Thomas Jefferson University
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.

Overall Status Recruiting
Start Date 2021-03-28
Completion Date 2023-03-01
Primary Completion Date 2022-03-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day Baseline to 12 weeks after physical activity promotion
Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day Baseline to 12 weeks after physical activity promotion
Change in Fitbit-recorded average active minutes (moderate and/or intensive) per day, each day Baseline to 12 weeks after physical activity promotion
Enrollment 20
Condition
Intervention

Intervention Type: Other

Intervention Name: Medical Device Usage and Evaluation

Description: Receive Fitbit

Intervention Type: Other

Intervention Name: Consultation

Description: Receive consultation from a physical therapist

Other Name: Consult

Intervention Type: Other

Intervention Name: Exercise Intervention

Description: Attend exercise training sessions

Arm Group Label: Arm I (exercise training, behavior modification)

Intervention Type: Behavioral

Intervention Name: Behavioral Intervention

Description: Attend sessions with a behavioral therapist

Arm Group Label: Arm I (exercise training, behavior modification)

Other Name: Behavior Conditioning Therapy

Intervention Type: Other

Intervention Name: Questionnaire Administration

Description: Ancillary studies

Intervention Type: Other

Intervention Name: Quality of Life Assessment

Description: Ancillary studies

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Location
Facility: Status: Contact: Thomas Jefferson University Hospital Grace Lu-Yao, MD 215-955-8874 [email protected]
Location Countries

United States

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm I (exercise training, behavior modification)

Type: Experimental

Description: 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.

Label: Arm II (Fitbit, consultation)

Type: Active Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

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