Clinical trial NCT01886703: Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy
Official title: Feasibility of a Supported Walking Program for Breast and Head-and-Neck Cancer Survivors Receiving Adjuvant Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Physical activity
Exercise
Quality of Life
Radiation Therapy
Breast Cancer
Head and Neck Cancer
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Accrual Rate and Completion Rate
timeFrame: Anticipated duration of radiation therapy of 6 weeks
Secondary outcomes:
measure: Adherence
timeFrame: Anticipated duration of radiation therapy of 6 weeks
Other outcomes:
measure: 6-Minute Walk Test
timeFrame: Change from baseline to anticipated end of radiation therapy of 6 weeks
measure: Physical Activity
timeFrame: Change from baseline to anticipated duration of radiation therapy of 6 weeks
measure: Self-esteem
timeFrame: Change from baseline to anticipated duration of radiation therapy of 6 weeks
measure: Depression
timeFrame: Change from baseline to anticipated duration of radiation therapy of 6 weeks
measure: Happiness
timeFrame: Change from baseline to anticipated duration of radiation therapy of 6 weeks
measure: Sleep
timeFrame: Change from baseline to anticipated duration of radiation therapy of 6 weeks
measure: Fatigue
timeFrame: Recorded daily during study period of 6 weeks
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta and Cross Cancer Institute
name: Margaret McNeely, PhD
role: PRINCIPAL_INVESTIGATOR
References: