Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy
I. To evaluate the feasibility of conducting a symptom-adapted, randomized behavioral
intervention designed to improve physical function in older adults receiving chemotherapy
II. To estimate the effect size of the physical activity intervention on change in an
objective measure of physical function, SPPB (short physical performance battery).
I. To estimate the effects of the physical activity intervention on self-reported physical
function, health-related quality of life, and symptoms (depression, distress, fatigue).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients participate in an orientation session introducing the exercise program and
protocol, reviewing fundamental principles, and demonstrating each activity. Patients also
receive educational materials to facilitate orientation and adherence. Patients are offered
20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days
a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes
ARM II: Patients undergo usual care for 4 weeks.
After completion of study treatment, patients are followed up every two weeks for two months
and then monthly until week 24.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Feasibility, in terms of participation rates and barriers to recruitment and retention
Number of exercise sessions completed, dropout rates, completion rates of the physical function measures, and completion rates of questionnaires will be recorded. Adherence will be defined as completion of at least 60% of the offered sessions.
Approximately 4 weeks
Wake Forest University
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|