Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy

Not Applicable

Completed

• Conditions: Physical Activity
• Interventions: Behavioral: Pedometer Walking Program

• Registration Number: NCT01886703
• Lead Sponsor: University of Alberta

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-16
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-26
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Walking Intervention	Pedometer Walking Program	Pedometer Walking Program

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adherence	Anticipated duration of radiation therapy of 6 weeks	Adherence to the intervention protocol: number of days meeting target step count

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada