Colorectal Cancer, Fatigue
Conditions
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
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.
Interventions
BEHAVIORALWalk With Ease
A self-directed walking intervention developed by the Arthritis Foundation. The intervention is a workbook that coaches participants through walking regularly at a safe, comfortable pace with the ultimate goal of walking at least 30 minutes a day five days a week.
Sponsors
LCCC Geriatric Oncology Program
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure the change in fatigue after three months between the intervention and control arm | Three Months | The investigators will compare the change in fatigue from baseline to 3 months between Intervention and Control arms as measured via PROMIS®-Fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To measure adherence to the physical activity intervention | One Year | To report on the adherence of the physical activity intervention as measured through self-reported minutes of walking per days and walking minutes per week in the group randomized to the Intervention arm |
| To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups | One Year | The investigators will comparee the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups |
| To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms | One Year | The investigators will compare the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups |
| To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy | Six months | To explore the association of baseline measurements of p16INK4a and muscle mass with changes in fatigue, physical function, and health related quality of life during adjuvant chemotherapy. |
| To measure changes in physical function at baseline between the intervention and control groups. | 4 to 24 weeks | To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms. • Physical function as measured by PROMIS-PF and SPPB |
| To measure changes in ADLs at baseline between the intervention and control groups. | 4 to 24 weeks | To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms. ADLs per CGA |
| To measure changes in Instrumental Activities of Daily Living at baseline between the intervention and control groups. | 4 to 24 weeks | To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms. IADLs per CGA |
| To measure changes in Self-Efficacy at baseline between the intervention and control groups. | 4 to 24 weeks | To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms. Self-efficacy and attitudes as measured by PSEFSM and OEE |
| To measure changes in Quality of Life at baseline between the intervention and control groups. | 4 to 24 weeks | To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms. Quality of life as measured by FACT-FCSI and PROMIS-PI |
Countries
United States
Outcome results
None listed