NCT02191969.

Study name	Physical activity intervention for older patients during chemotherapy for colorectal cancer
Methods	Study design: RCT Country where study is being conducted: USA
Participants	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 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
Interventions	Intervention details: participants will take part in the Walk With Ease (WWE) programme during the course of their chemotherapy treatment. They will be requested to initiate the WWE starting on Day 1 of adjuvant chemotherapy. Participants are asked to walk at a safe and comfortable pace, increasing their minutes per day at a rate they can sustain, with the ultimate goal of 30 minutes/day for at least 5 days/week. They are asked to maintain a daily walking log that is provided to them, entering total minutes per day. Participants will be asked to do the walking programme independently (self‐directed, not in a formal group with an instructor) throughout chemotherapy. Comparator details: standard care
Outcomes	Primary outcome measures: change in fatigue (measured via PROMIS‐Fatigue) changes in physical function (measured via PROMIS‐PF and SPPB) adherence to the physical activity intervention (measured through self‐reported minutes of walking per days and walking minutes per week) difference in p16INK4a levels (change in p16INK4a and muscle mass measurements pre‐/postadjuvant chemotherapy) change in muscle mass measurements (change in p16INK4a and muscle mass measurements) association of p16INK4a and muscle mass with any differences in fatigue, physical function or QoL during chemotherapy quality of life (FACT‐FCSI and PROMIS‐PI) changes in activities of daily living changes in instrumental activities of daily living changes in self‐efficacy (measured by PSEFSM and OEE) Time points measured: baseline, 3 months, and after completion of chemotherapy (24 weeks), some outcomes measured at 1 year
Starting date	June 2014
Contact information	Kirsten A Nyrop knyrop@med.unc.edu Amy L Garrrett amy_garrett@med.unc.edu
Notes	Trial registration identifier:NCT02191969 Trial registration link: https://clinicaltrials.gov/ct2/show/NCT02191969 Sponsor: UNC Lineberger Comprehensive Cancer Center