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

May 19, 2025 updated by: Thomas Jefferson University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: Questionnaire Administration
Ancillary studies
Other: Quality of Life Assessment
Ancillary studies
Other: Medical Device Usage and Evaluation
Receive Fitbit
Other: Consultation
Receive consultation from a physical therapist
Other Names:
  • Consult
Other: Exercise Intervention
Attend exercise training sessions
Behavioral: Behavioral Intervention
Attend sessions with a behavioral therapist
Other Names:
  • Behavior Conditioning Therapy
Active Comparator: 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.
Other: Questionnaire Administration
Ancillary studies
Other: Quality of Life Assessment
Ancillary studies
Other: Medical Device Usage and Evaluation
Receive Fitbit
Other: Consultation
Receive consultation from a physical therapist
Other Names:
  • Consult

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day
Time Frame: Baseline to 12 weeks after physical activity promotion
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
Time Frame: Baseline to 12 weeks after physical activity promotion
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 Frame: Baseline to 12 weeks after physical activity promotion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20D.775
  • JT 15554 (Other Identifier: JeffTrial Number)
  • 108 27000 908059 (Other Grant/Funding Number: Population Science Cancer Research Fund)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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