Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy

Physical Activity Clinical Trial

— PEDWAY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886703
• Other study ID #: ACREC 26059
• Status: Completed
• Phase: N/A
• First received: June 16, 2013
• Last updated: May 1, 2017
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Self-esteem	Rosenberg Self-Esteem Scale (10 item)	Change from baseline to anticipated duration of radiation therapy of 6 weeks
Other	Depression	Beck Depression Inventory II (21 item)	Change from baseline to anticipated duration of radiation therapy of 6 weeks
Other	Happiness	Oxford Happiness Questionnaire (29 items)	Change from baseline to anticipated duration of radiation therapy of 6 weeks
Other	Sleep	Pittsburgh Sleep Quality Index (9 item)	Change from baseline to anticipated duration of radiation therapy of 6 weeks
Other	Fatigue	Visual analogue scale, recorded as part of daily diary	Recorded daily during study period of 6 weeks
Primary	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	Adherence	Adherence to the intervention protocol: number of days meeting target step count	Anticipated duration of radiation therapy of 6 weeks