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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Physical Activity

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Accrual Rate and Completion Rate

Outcome Description:

Accrual: Number of participants agreeing to participate divided by the number of eligible participants Completion rate: number of participants completing the trial

Outcome Time Frame:

Anticipated duration of radiation therapy of 6 weeks

Safety Issue:

No

Principal Investigator

Margaret McNeely, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alberta and Cross Cancer Institute

Authority:

Canada: Ethics Review Committee

Study ID:

ACREC 26059

NCT ID:

NCT01886703

Start Date:

June 2013

Completion Date:

December 2013

Related Keywords:

  • Physical Activity
  • Physical activity
  • Exercise
  • Quality of Life
  • Radiation Therapy
  • Breast Cancer
  • Head and Neck Cancer
  • Head and Neck Neoplasms

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