Clinical trial NCT02191969: Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer
Official title: The Impact of a Physical Activity Intervention in Older Patients Undergoing Adjuvant Chemotherapy for Colorectal Cancer: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Fatigue
Keywords: Chemotherapy
Adjuvant Chemotherapy
Cancer Therapy
Fatigue
Physical Activity
Physical Function
Tiredness
Colon Cancer
Rectal Cancer
Walk With Ease
Colorectal Cancer
Geriatric Assessment
Geriatric
Elderly
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: LCCC Geriatric Oncology Program
First posted: 2014-07-16
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will see if patient who undergo a physical activity intervention called Walk With Ease report experiencing less fatigue and a higher quality of life during chemotherapy for colorectal cancer than those who do not participate in this intervention.

Detailed description: The primary purpose of this multicenter, randomized controlled study is to evaluate the impact of a physical activity program on fatigue in older patients (≥60 years) undergoing adjuvant chemotherapy for colorectal cancer. The investigators also plan to evaluate physical function and quality of life as secondary objectives. The investigators' hypotheses are that people who undergo the physical activity intervention compared to those who do not, will: 1) report less fatigue, 2) report higher health related quality of life, and 3) have less decline in physical function. Additionally, The investigators will characterize ≥grade 3 adjuvant chemotherapy associated toxicities in this older population, and describe the changes reported in fatigue, physical function, and HRQOL over the course of chemotherapy.

Eligibility criteria: Inclusion Criteria:

* ≥ Age 60 years (no upper age limit)
* Diagnosis of stage II-III colon or rectal cancer planned for treatment with adjuvant chemotherapy scheduled as part of standard treatment
* Able to read English (required for CGA and other surveys administered)
* Approval from their treating physician to engage in moderate-intensity physical activity
* Patient-assessed ability to walk and engage in moderate physical activity
* Signed, IRB-approved written informed consent

Exclusion Criteria:

* Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy
* Already walking or engaging in other physical activity \>120 minutes per week as documented via subject self-report
* Unable to walk or engage in moderate-intensity physical activity
* One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention

Primary outcomes:
measure: To measure the change in fatigue after three months between the intervention and control arm
timeFrame: Three Months
Secondary outcomes:
measure: To measure changes in physical function at baseline between the intervention and control groups.
timeFrame: 4 to 24 weeks
measure: To measure adherence to the physical activity intervention
timeFrame: One Year
measure: To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups
timeFrame: One Year
measure: To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms
timeFrame: One Year
measure: To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy
timeFrame: Six months
measure: To measure changes in Quality of Life at baseline between the intervention and control groups.
timeFrame: 4 to 24 weeks
measure: To measure changes in ADLs at baseline between the intervention and control groups.
timeFrame: 4 to 24 weeks
measure: To measure changes in Instrumental Activities of Daily Living at baseline between the intervention and control groups.
timeFrame: 4 to 24 weeks
measure: To measure changes in Self-Efficacy at baseline between the intervention and control groups.
timeFrame: 4 to 24 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Hy Muss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams GR, Nyrop KA, Deal AM, Muss HB, Sanoff HK. Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial. Contemp Clin Trials. 2015 May;42:90-7. doi: 10.1016/j.cct.2015.03.008. Epub 2015 Mar 28.