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Completed

NCT Number: NCT01886703

Feasibility of a Walking Program for Cancer Survivors Receiving 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.

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Key information

Conditions

Physical Activity Behavior Breast Diseases Breast Neoplasms Head and Neck Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cross Cancer Institute

Edmonton, Alberta, T6J4P9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pedometer Walking Program

Behavioral

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.

Primary outcomes

  1. Accrual Rate and Completion Rate

    Time frame: Anticipated duration of radiation therapy of 6 weeks

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

Secondary outcomes

  1. Adherence

    Time frame: Anticipated duration of radiation therapy of 6 weeks

    Adherence to the intervention protocol: number of days meeting target step count

Other outcomes

  1. 6-Minute Walk Test

    Time frame: Change from baseline to anticipated end of radiation therapy of 6 weeks

    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).

  2. Physical Activity

    Time frame: Change from baseline to anticipated duration of radiation therapy of 6 weeks

    An accelerometer armband will be used to provide a breakdown of an individual's daily activity.

  3. Self-esteem

    Time frame: Change from baseline to anticipated duration of radiation therapy of 6 weeks

    Rosenberg Self-Esteem Scale (10 item)

  4. Depression

    Time frame: Change from baseline to anticipated duration of radiation therapy of 6 weeks

    Beck Depression Inventory II (21 item)

  5. Happiness

    Time frame: Change from baseline to anticipated duration of radiation therapy of 6 weeks

    Oxford Happiness Questionnaire (29 items)

  6. Sleep

    Time frame: Change from baseline to anticipated duration of radiation therapy of 6 weeks

    Pittsburgh Sleep Quality Index (9 item)

  7. Fatigue

    Time frame: Recorded daily during study period of 6 weeks

    Visual analogue scale, recorded as part of daily diary

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: PEDWAY

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2013
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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