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

  • STATUS
    Recruiting
  • End date
    Mar 16, 2023
  • participants needed
    20
  • sponsor
    Thomas Jefferson University
Updated on 16 June 2021
cancer

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.

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.

Details
Condition Lung Cancer, Oral Cavity Carcinoma, Stage III Laryngeal Cancer AJCC v8, Laryngeal Carcinoma, Stage II Laryngeal Cancer AJCC v8, Carcinoma of the Head and Neck, Oral Cavity Cancer, mouth cancer, carcinoma lung, Paranasal Sinus Cancer, Stage IVA Laryngeal Cancer AJCC v8, oropharyngeal carcinoma, Stage IVC Laryngeal Cancer AJCC v8, carcinoma of oral cavity, Oropharyngeal Cancer, Lung Neoplasm, Sinonasal Carcinoma, Stage IVB Laryngeal Cancer AJCC v8, carcinoma of hypopharynx, Stage I Laryngeal Cancer AJCC v8, carcinoma of oropharynx, lung carcinoma, Maxillary Sinus Carcinoma, cancer, oropharynx, Head and Neck Carcinoma, Stage IV Laryngeal Cancer AJCC v8, Hypopharyngeal Carcinoma
Treatment questionnaire administration, quality of life assessment, exercise intervention, behavioral intervention, Consultation, Medical Device Usage and Evaluation
Clinical Study IdentifierNCT04788264
SponsorThomas Jefferson University
Last Modified on16 June 2021

Eligibility

Yes No Not Sure

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note