Clinical trial NCT01053468: Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
Official title: Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
physical activity
quality of life
theory of planned behavior
behavior change
health promotion
Lead sponsor: Athabasca University
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: University of Calgary
name: Alberta Health services
First posted: 2010-01-21
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Self-reported physical activity
timeFrame: Baseline, post intervention, 6 months follow up
Secondary outcomes:
measure: Cancer specific health related quality of life
timeFrame: Baseline, post intervention, 6 months follow up
measure: Psychosocial health outcomes
timeFrame: Baseline, post intervention, 6 months follow up
measure: Objective step counts (pedometer)
timeFrame: Baseline, post intervention, 6 months follow up
measure: Chemotherapy completion rate
timeFrame: Baseline, post intervention, 6 months follow up
measure: Determinants of physical activity
timeFrame: Baseline, post intervention, 6 months follow up
measure: Physical functioning
timeFrame: Baseline, post intervention, 6 months follow up
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Grande Prairie
country: Canada
facility: Grande Prairie Cancer Centre
state: Alberta
city: Lethbridge
country: Canada
facility: Lethbridge Cancer Centre
state: Alberta
city: Medicine Hat
country: Canada
facility: Medicine Hat Cancer Centre
state: Alberta
city: Red Deer
country: Canada
facility: Central Alberta Cancer Centre
state: Alberta
Study officials:
affiliation: Athabasca University
name: Jeff Vallance, PhD
role: PRINCIPAL_INVESTIGATOR
References: