Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788264
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2021-03-04
Brief Title:
Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None