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Clinical Trials/NCT01886703
NCT01886703
Completed
N/A

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

University of Alberta1 site in 1 country21 target enrollmentJune 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Physical Activity
Sponsor
University of Alberta
Enrollment
21
Locations
1
Primary Endpoint
Accrual Rate and Completion Rate
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
December 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Margie McNeely

Assistant Professor

University of Alberta

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Accrual Rate and Completion Rate

Time Frame: 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 Outcomes

  • Adherence(Anticipated duration of radiation therapy of 6 weeks)

Study Sites (1)

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