Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy (PEDWAY)

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Behavioral: Pedometer Walking Program

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6J4P9
      • Cross Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Walking Intervention; Pedometer Walking Program

Behavioral: Pedometer Walking Program; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Minute Walk Test	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a six minutes time period on a hard, flat surface (e.g., 100 foot hallway).	Change from baseline to anticipated end of radiation therapy of 6 weeks
Physical Activity	An accelerometer armband will be used to provide a breakdown of an individual's daily activity.	Change from baseline to anticipated duration of radiation therapy of 6 weeks
Self-esteem	Rosenberg Self-Esteem Scale (10 item)	Change from baseline to anticipated duration of radiation therapy of 6 weeks
Depression	Beck Depression Inventory II (21 item)	Change from baseline to anticipated duration of radiation therapy of 6 weeks
Happiness	Oxford Happiness Questionnaire (29 items)	Change from baseline to anticipated duration of radiation therapy of 6 weeks
Sleep	Pittsburgh Sleep Quality Index (9 item)	Change from baseline to anticipated duration of radiation therapy of 6 weeks
Fatigue	Visual analogue scale, recorded as part of daily diary	Recorded daily during study period of 6 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Margaret McNeely, PhD, University of Alberta and Cross Cancer Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 16, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (Estimate): June 26, 2013

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Breast Cancer; Head and Neck Cancer; Quality of Life; Physical activity; Radiation Therapy
• Other Study ID Numbers: ACREC 26059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No plan in place