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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Margie McNeely, University of Alberta
ClinicalTrials.gov Identifier:
NCT01886703
First received: June 16, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Physical Activity
Behavioral: Pedometer Walking Program
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility of a Supported Walking Program for Breast and Head-and-Neck Cancer Survivors Receiving Adjuvant Radiation Therapy

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Accrual Rate and Completion Rate [ Time Frame: Anticipated duration of radiation therapy of 6 weeks ] [ Designated as safety issue: No ]
    Accrual: Number of participants agreeing to participate divided by the number of eligible participants Completion rate: number of participants completing the trial


Secondary Outcome Measures:
  • Adherence [ Time Frame: Anticipated duration of radiation therapy of 6 weeks ] [ Designated as safety issue: No ]
    Adherence to the intervention protocol: number of days meeting target step count


Other Outcome Measures:
  • 6-Minute Walk Test [ Time Frame: Change from baseline to anticipated end of radiation therapy of 6 weeks ] [ Designated as safety issue: No ]
    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).

  • Physical Activity [ Time Frame: Change from baseline to anticipated duration of radiation therapy of 6 weeks ] [ Designated as safety issue: No ]
    An accelerometer armband will be used to provide a breakdown of an individual's daily activity.

  • Self-esteem [ Time Frame: Change from baseline to anticipated duration of radiation therapy of 6 weeks ] [ Designated as safety issue: No ]
    Rosenberg Self-Esteem Scale (10 item)

  • Depression [ Time Frame: Change from baseline to anticipated duration of radiation therapy of 6 weeks ] [ Designated as safety issue: No ]
    Beck Depression Inventory II (21 item)

  • Happiness [ Time Frame: Change from baseline to anticipated duration of radiation therapy of 6 weeks ] [ Designated as safety issue: No ]
    Oxford Happiness Questionnaire (29 items)

  • Sleep [ Time Frame: Change from baseline to anticipated duration of radiation therapy of 6 weeks ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index (9 item)

  • Fatigue [ Time Frame: Recorded daily during study period of 6 weeks ] [ Designated as safety issue: No ]
    Visual analogue scale, recorded as part of daily diary


Estimated Enrollment: 20
Study Start Date: June 2013
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886703

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6J4P9
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Margaret McNeely, PhD University of Alberta and Cross Cancer Institute
  More Information

No publications provided

Responsible Party: Margie McNeely, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01886703     History of Changes
Other Study ID Numbers: ACREC 26059
Study First Received: June 16, 2013
Last Updated: January 10, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Physical activity
Exercise
Quality of Life
Radiation Therapy
Breast Cancer
Head and Neck Cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 30, 2014