Breast CancerPhase 2PROACTIVENCT01053468
Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
A Phase 2 study testing Physical Activity Resource Kit and Standard Materials in people with Breast Cancer, run by Athabasca University at 5 sites in Canada.
Trial summary
Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Physical Activity Resource Kit and Standard Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesCanada
- Study dates
- Aug 2010to Apr 2013
- Phase
- Phase 2
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are diagnosed with stage I -IIIA breast cancer
- are scheduled to receive neoadjuvant or adjuvant chemotherapy
- did not receive transabdominal rectus abdominus muscle (TRAM) reconstructive surgery
- are >18 years of age
- receive approval from their treating oncologist to participate
- do not have uncontrolled hypertension, cardiac illness, or psychiatric conditions (i.e., indicated in patient medical charts).
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
Celeste Lavallee, BSc, RD contact
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Tom Baker Cancer Centre
Calgary, Alberta
- Recruiting
Grande Prairie Cancer Centre
Grande Prairie, Alberta
- Recruiting
Lethbridge Cancer Centre
Lethbridge, Alberta
- Recruiting
Medicine Hat Cancer Centre
Medicine Hat, Alberta
- Recruiting
Central Alberta Cancer Centre
Red Deer, Alberta
About this study
Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.
The investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.
Read the detailed description
Primary Objective:
To compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).
- Conditions
- Breast Cancer
- Being tested
- Physical Activity Resource Kit, Standard Materials
- Keywords
- breast cancer, physical activity, quality of life, theory of planned behavior, behavior change, health promotion
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Resource KitBehavioural
The Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities.
Participants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration).
Standard MaterialsBehavioural
Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
| Study group | Role | What they receive |
|---|---|---|
| PA Behavior Intervention | Experimental | Physical Activity Resource Kit Receives: Behavioral: Physical Activity Resource Kit |
| Standard Materials | Active comparator | Receive physical activity handout from the Canadian Public Health Agency Receives: Behavioral: Standard Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported physical activity
Measured: Baseline, post intervention, 6 months follow up
Secondary outcomes (6)
Cancer specific health related quality of life
Measured: Baseline, post intervention, 6 months follow up
Psychosocial health outcomes
Measured: Baseline, post intervention, 6 months follow up
Objective step counts (pedometer)
Measured: Baseline, post intervention, 6 months follow up
Chemotherapy completion rate
Measured: Baseline, post intervention, 6 months follow up
Determinants of physical activity
Measured: Baseline, post intervention, 6 months follow up
Physical functioning
Measured: Baseline, post intervention, 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Athabasca University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, University of Calgary, Alberta Health services
- Investigators
- Jeff Vallance, PhD, Principal investigator, Athabasca University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053468
- Sponsor's protocol ID
- PROACTIVE
- Acronym
- PROACTIVE
- Status last verified
- Jan 2010
- First submitted
- 20 Jan 2010
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01053468
- Acronym / sponsor ID
- PROACTIVE / PROACTIVE
- Conditions
- Breast Cancer
- Keywords
- breast cancer, physical activity, quality of life, theory of planned behavior, behavior change, health promotion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Athabasca UniversityUniversity, hospital or other
- Collaborators
- University of Alberta, University of Calgary, Alberta Health services
- Study start
- Aug 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 21 Jan 2010 (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.
Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.
The investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.
Detailed description
Primary Objective:
To compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PA Behavior Intervention | Experimental | Behavioral: Physical Activity Resource KitPhysical Activity Resource Kit |
| Standard Materials | Active comparator | Behavioral: Standard MaterialsReceive physical activity handout from the Canadian Public Health Agency |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- are diagnosed with stage I -IIIA breast cancer
- are scheduled to receive neoadjuvant or adjuvant chemotherapy
- did not receive transabdominal rectus abdominus muscle (TRAM) reconstructive surgery
- are >18 years of age
- receive approval from their treating oncologist to participate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Physical Activity Resource KitThe Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities. Participants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration). | Behavioural | PA Behavior Intervention |
| Standard MaterialsParticipants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency | Behavioural | Standard Materials |
Primary outcome
Self-reported physical activity
Time frame: Baseline, post intervention, 6 months follow up
6 secondary outcomes
Cancer specific health related quality of life
Time frame: Baseline, post intervention, 6 months follow up
Psychosocial health outcomes
Time frame: Baseline, post intervention, 6 months follow up
Objective step counts (pedometer)
Time frame: Baseline, post intervention, 6 months follow up
Chemotherapy completion rate
Time frame: Baseline, post intervention, 6 months follow up
Determinants of physical activity
Time frame: Baseline, post intervention, 6 months follow up
Physical functioning
Time frame: Baseline, post intervention, 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
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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.
Celeste Lavallee, BSc, RD contact
Jeff Vallance, PhD principal investigator
Athabasca University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Physical Activity Resource Kit and Standard Materials in people with Breast Cancer, run by Athabasca University at 5 sites 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 6 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeff Vallance, PhD (403-488-7179, jeffv@athabascau.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported physical activity (time frame: Baseline, post intervention, 6 months follow up). 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 1 Jul 2011.