Physical ActivityPEDWAYNCT01886703
Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy
A study testing Pedometer Walking Program in people with Physical Activity, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Pedometer Walking Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Pedometer Walking Program
- Keywords
- Physical activity, Exercise, Quality of Life, Radiation Therapy, Breast Cancer, Head and Neck Cancer
- Medical subject headings
- Motor Activity, Breast Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometer Walking ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Walking Intervention | Experimental | Pedometer Walking Program Receives: Behavioral: Pedometer Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Anticipated duration of radiation therapy of 6 weeks
Secondary outcomes (1)
Adherence
Adherence to the intervention protocol: number of days meeting target step count
Measured: Anticipated duration of radiation therapy of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margie McNeely, University of Alberta
- Investigators
- Margaret McNeely, PhD, Principal investigator, University of Alberta and Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886703
- Sponsor's protocol ID
- ACREC 26059
- Acronym
- PEDWAY
- Status last verified
- May 2017
- First submitted
- 16 Jun 2013
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: No plan in place
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Supported Walking Program for Breast and Head-and-Neck Cancer Survivors Receiving Adjuvant Radiation Therapy
- ClinicalTrials.gov ID
- NCT01886703
- Acronym / sponsor ID
- PEDWAY / ACREC 26059
- Conditions
- Physical Activity
- Keywords
- Physical activity, Exercise, Quality of Life, Radiation Therapy, Breast Cancer, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walking Intervention | Experimental | Behavioral: Pedometer Walking ProgramPedometer Walking Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedometer Walking ProgramAll 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. | Behavioural | Walking Intervention |
Primary outcome
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
1 secondary outcome
Adherence
Time frame: Anticipated duration of radiation therapy of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Individual participant dataSharing planned: Undecided. No plan in place
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret McNeely, PhD principal investigator
University of Alberta and Cross Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer Walking Program in people with Physical Activity, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual Rate and Completion Rate (time frame: Anticipated duration of radiation therapy of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.