Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of a Supported Walking Program for Breast and Head-and-Neck Cancer Survivors Receiving Adjuvant Radiation Therapy

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Pedometer Walking Program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking Intervention<br>Pedometer Walking Program | Behavioral: Pedometer Walking Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual Rate and Completion Rate | Accrual: Number of participants agreeing to participate divided by the number of eligible participants Completion rate: number of participants completing the trial | Anticipated duration of radiation therapy of 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Adherence to the intervention protocol: number of days meeting target step count | Anticipated duration of radiation therapy of 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Exercise, Quality of Life, Radiation Therapy, Breast Cancer, Head and Neck Cancer