Physical Activity
Conditions
Keywords
Physical activity, Exercise, Quality of Life, Radiation Therapy, Breast Cancer, Head and Neck Cancer
Brief summary
This pilot study will assess whether a supported pedometer-based walking program is helpful in maintaining physical activity for breast and head-and-neck cancer patients who are undergoing radiation therapy. Follow-up monitoring sessions will be scheduled to help provide support for physical activity during radiation therapy. We will also examine the relationship of physical activity and quality of life outcomes to help inform future research.
Detailed description
Will the integration of a patient-centered exercise prescription and supportive counseling attenuate declines in physical activity during radiation therapy? To address this question, this study will assess the feasibility of a patient-centered walking program for breast and head-and-neck cancer patients undergoing radiation therapy. Follow-up monitoring sessions will be scheduled to help provide support and ongoing counseling to facilitate increased activity (through walking) during radiation therapy. We will also examine the effect of the walking program on other outcomes such as happiness, depression and sleep to determine point estimates and measures of variability to inform future research.
Interventions
BEHAVIORALPedometer Walking Program
All subjects will be prescribed a low-intensity walking program based on their current activity level and an daily assigned step count goal (with the current physical activity recommendations of 30 minutes of moderate-to-vigorous activity per day or 150 minutes per week as the ideal goal). Participants will be provided with face-to-face counseling and written material describing their specific individualized walking program. Participants will also be instructed to maintain their normal activities as much as possible during the intervention period. Participants will be given a pedometer and instructed to wear it at least 5 days per week for the duration of the study.
Sponsors
University of Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Survivors with a diagnosis of breast cancer or head and neck cancer * Adults aged 18 years or older * Commencing adjuvant radiation therapy treatments * Karnofsky Performance Status greater than or equal to 60%
Exclusion criteria
* Clinical or radiological evidence of active disease, either local or metastatic * Serious non-malignant disease, such as cardiac failure or advanced arthritis of weight bearing joints, which would preclude daily treatment and follow-up * Patients for whom physical activity or exercise is contraindicated * Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol * Unable to comply with the protocol, measurement and follow-up schedule (e.g., scheduling conflicts, time commitment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual Rate and Completion Rate | Anticipated duration of radiation therapy of 6 weeks | Accrual: Number of participants agreeing to participate divided by the number of eligible participants Completion rate: number of participants completing the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | Anticipated duration of radiation therapy of 6 weeks | Adherence to the intervention protocol: number of days meeting target step count |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-esteem | Change from baseline to anticipated duration of radiation therapy of 6 weeks | Rosenberg Self-Esteem Scale (10 item) |
| Depression | Change from baseline to anticipated duration of radiation therapy of 6 weeks | Beck Depression Inventory II (21 item) |
| 6-Minute Walk Test | Change from baseline to anticipated end of radiation therapy of 6 weeks | The six-minute walk test (6MWT) measures the distance an individual is able to walk over a six minutes time period on a hard, flat surface (e.g., 100 foot hallway). |
| Sleep | Change from baseline to anticipated duration of radiation therapy of 6 weeks | Pittsburgh Sleep Quality Index (9 item) |
| Fatigue | Recorded daily during study period of 6 weeks | Visual analogue scale, recorded as part of daily diary |
| Happiness | Change from baseline to anticipated duration of radiation therapy of 6 weeks | Oxford Happiness Questionnaire (29 items) |
| Physical Activity | Change from baseline to anticipated duration of radiation therapy of 6 weeks | An accelerometer armband will be used to provide a breakdown of an individual's daily activity. |
Countries
Canada
Outcome results
None listed