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Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy

Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01053468
Acronym
PROACTIVE
Enrollment
150
Registered
2010-01-21
Start date
2010-08-31
Completion date
2013-04-30
Last updated
2011-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, physical activity, quality of life, theory of planned behavior, behavior change, health promotion

Brief 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. 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).

Interventions

BEHAVIORALPhysical Activity Resource Kit

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).

Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency

Sponsors

University of Alberta
CollaboratorOTHER
University of Calgary
CollaboratorOTHER
Alberta Health services
CollaboratorOTHER
Athabasca University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frame
Self-reported physical activityBaseline, post intervention, 6 months follow up

Secondary

MeasureTime frame
Psychosocial health outcomesBaseline, post intervention, 6 months follow up
Objective step counts (pedometer)Baseline, post intervention, 6 months follow up
Cancer specific health related quality of lifeBaseline, post intervention, 6 months follow up
Determinants of physical activityBaseline, post intervention, 6 months follow up
Physical functioningBaseline, post intervention, 6 months follow up
Chemotherapy completion rateBaseline, post intervention, 6 months follow up

Countries

Canada

Contacts

Primary ContactJeff Vallance, PhD
jeffv@athabascau.ca403-488-7179
Backup ContactCeleste Lavallee, BSc, RD
clavallee@athabascau.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026