Colorectal Cancer Clinical Trial
Official title:
The Impact of a Physical Activity Intervention in Older Patients Undergoing Adjuvant Chemotherapy for Colorectal Cancer: a Randomized, Controlled Trial
NCT number | NCT02191969 |
Other study ID # | LCCC1324 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | September 18, 2019 |
Verified date | November 2019 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | September 18, 2019 |
Est. primary completion date | September 18, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | LCCC Geriatric Oncology Program |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure the change in fatigue after three months between the intervention and control arm | The investigators will compare the change in fatigue from baseline to 3 months between Intervention and Control arms as measured via PROMIS®-Fatigue. | Three Months | |
Secondary | To measure changes in physical function at baseline between the intervention and control groups. | 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 |
4 to 24 weeks | |
Secondary | To measure adherence to the physical activity intervention | 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 | One Year | |
Secondary | To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups | The investigators will comparee the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups | One Year | |
Secondary | To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms | The investigators will compare the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups | One Year | |
Secondary | To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy | 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. | Six months | |
Secondary | To measure changes in Quality of Life at baseline between the intervention and control groups. | 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 |
4 to 24 weeks | |
Secondary | To measure changes in ADLs at baseline between the intervention and control groups. | 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 |
4 to 24 weeks | |
Secondary | To measure changes in Instrumental Activities of Daily Living at baseline between the intervention and control groups. | 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 |
4 to 24 weeks | |
Secondary | To measure changes in Self-Efficacy at baseline between the intervention and control groups. | 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 |
4 to 24 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
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