Head and Neck CarcinomaNCT04788264
Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment
A study testing Medical Device Usage and Evaluation, Consultation and Exercise Intervention in people with Head and Neck Carcinoma and Hypopharyngeal Carcinoma, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma, Hypopharyngeal Carcinoma, Laryngeal Carcinoma
- What is being tested?
- Medical Device Usage and Evaluation, Consultation and Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2021to 29 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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:
- 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
- Being tested
- Medical Device Usage and Evaluation, Consultation, Exercise Intervention, Behavioral Intervention, Questionnaire Administration
- Medical subject headings
- Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Maxillary Sinus Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms, Paranasal Sinus Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device Usage and EvaluationOther
Receive Fitbit
ConsultationOther
Also called Consult
Receive consultation from a physical therapist
Exercise InterventionOther
Attend exercise training sessions
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy
Attend sessions with a behavioral therapist
Questionnaire AdministrationOther
Ancillary studies
Quality of Life AssessmentOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Medical Device Usage and Evaluation; Other: Consultation; Other: Questionnaire Administration; Other: Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline to 12 weeks after physical activity promotion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start28 Mar 2021
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788264
- Sponsor's protocol ID
- 20D.775
- Other IDs
- JT 15554, 108 27000 908059
- Status last verified
- May 2025
- First submitted
- 4 Mar 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04788264
- Acronym / sponsor ID
- 20D.775
- Conditions
- Head and Neck Carcinoma, Hypopharyngeal Carcinoma, Laryngeal Carcinoma, Maxillary Sinus Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 28 Mar 2021 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (exercise training, behavior modification) | Experimental | Other: Medical Device Usage and Evaluation, Other: Consultation, Other: Exercise Intervention, Behavioral: Behavioral Intervention, Other: Questionnaire Administration, Other: Quality of Life AssessmentBeginning 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 (Fitbit, consultation) | Active comparator | Other: Medical Device Usage and Evaluation, Other: Consultation, Other: Questionnaire Administration, Other: Quality of Life AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device Usage and EvaluationReceive Fitbit | Other | Arm I (exercise training, behavior modification), Arm II (Fitbit, consultation) |
| ConsultationAlso: ConsultReceive consultation from a physical therapist | Other | Arm I (exercise training, behavior modification), Arm II (Fitbit, consultation) |
| Exercise InterventionAttend exercise training sessions | Other | Arm I (exercise training, behavior modification) |
| Behavioral InterventionAlso: Behavior Conditioning TherapyAttend sessions with a behavioral therapist | Behavioural | Arm I (exercise training, behavior modification) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (exercise training, behavior modification), Arm II (Fitbit, consultation) |
| Quality of Life AssessmentAncillary studies | Other | Arm I (exercise training, behavior modification), Arm II (Fitbit, consultation) |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device Usage and Evaluation, Consultation and Exercise Intervention in people with Head and Neck Carcinoma and Hypopharyngeal Carcinoma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fitbit-recorded average steps (moderate and/or intensive) per day, each day (time frame: Baseline to 12 weeks after physical activity promotion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.