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

NCT ID: NCT04788264

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-28
• Study Completion Date: 2023-06-29

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (exercise training, behavior modification)

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.

Group Type: EXPERIMENTAL

Medical Device Usage and Evaluation

Intervention Type: OTHER

Receive Fitbit

Consultation

Intervention Type: OTHER

Receive consultation from a physical therapist

Exercise Intervention

Intervention Type: OTHER

Attend exercise training sessions

Behavioral Intervention

Intervention Type: BEHAVIORAL

Attend sessions with a behavioral therapist

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Quality of Life Assessment

Intervention Type: OTHER

Ancillary studies

Arm II (Fitbit, consultation)

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.

Group Type: ACTIVE_COMPARATOR

Medical Device Usage and Evaluation

Intervention Type: OTHER

Receive Fitbit

Consultation

Intervention Type: OTHER

Receive consultation from a physical therapist

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Quality of Life Assessment

Intervention Type: OTHER

Ancillary studies

Interventions

Medical Device Usage and Evaluation

Receive Fitbit

Intervention Type: OTHER

Consultation

Receive consultation from a physical therapist

Intervention Type: OTHER

Exercise Intervention

Attend exercise training sessions

Intervention Type: OTHER

Behavioral Intervention

Attend sessions with a behavioral therapist

Intervention Type: BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Quality of Life Assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Consult; Behavior Conditioning Therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JT 15554

Identifier Type: OTHER

Identifier Source: secondary_id

108 27000 908059

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20D.775

Identifier Type: -

Identifier Source: org_study_id