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

NCT04788264 | Completed

• 3 other identifiers: 20D.775JT 15554108 27000 908059
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Arm I (exercise training, behavior modification)

EXPERIMENTAL

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.

Other: Medical Device Usage and Evaluation; Other: Consultation; Other: Exercise Intervention; Behavioral: Behavioral Intervention; Other: Questionnaire Administration; Other: Quality of Life Assessment

Arm II (Fitbit, consultation)

ACTIVE COMPARATOR

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.

Other: Medical Device Usage and Evaluation; Other: Consultation; Other: Questionnaire Administration; Other: Quality of Life Assessment

Interventions

Medical Device Usage and Evaluation OTHER

Receive Fitbit

Arm I (exercise training, behavior modification); Arm II (Fitbit, consultation)

Consultation OTHER

Receive consultation from a physical therapist

Also known as: Consult

Arm I (exercise training, behavior modification); Arm II (Fitbit, consultation)

Exercise Intervention OTHER

Attend exercise training sessions

Arm I (exercise training, behavior modification)

Behavioral Intervention BEHAVIORAL

Attend sessions with a behavioral therapist

Also known as: Behavior Conditioning Therapy

Arm I (exercise training, behavior modification)

Questionnaire Administration OTHER

Ancillary studies

Arm I (exercise training, behavior modification); Arm II (Fitbit, consultation)

Quality of Life Assessment OTHER

Ancillary studies

Arm I (exercise training, behavior modification); Arm II (Fitbit, consultation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Maxillary Sinus Neoplasms; Mouth Neoplasms; Oropharyngeal Neoplasms; Paranasal Sinus Neoplasms; Lung Neoplasms

Interventions

Referral and Consultation; Behavior Therapy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Nose Neoplasms; Nose Diseases; Paranasal Sinus Diseases; Mouth Diseases; Thoracic Neoplasms; Lung Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: March 28, 2021
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)