NCT01886703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

June 16, 2013

Last Update Submit

May 1, 2017

Conditions

Physical Activity

Keywords

Physical activityExerciseQuality of LifeRadiation TherapyBreast CancerHead and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adherence

    Anticipated duration of radiation therapy of 6 weeks

Other Outcomes (7)

  • 6-Minute Walk Test

    Change from baseline to anticipated end of radiation therapy of 6 weeks

  • Physical Activity

    Change from baseline to anticipated duration of radiation therapy of 6 weeks

  • Self-esteem

    Change from baseline to anticipated duration of radiation therapy of 6 weeks

  • +4 more other outcomes

Study Arms (1)

Walking Intervention

EXPERIMENTAL

Pedometer Walking Program

Behavioral: Pedometer Walking Program

Interventions

Pedometer Walking ProgramBEHAVIORAL

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.

Walking Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6J4P9, Canada

Location

MeSH Terms

Conditions

Motor ActivityBreast NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Margaret McNeely, PhD

    University of Alberta and Cross Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 16, 2013

First Posted

June 26, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

CA(1)