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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PA Behavior Intervention

Physical Activity Resource Kit

Group Type EXPERIMENTAL

Physical Activity Resource Kit

Intervention Type BEHAVIORAL

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 Materials

Receive physical activity handout from the Canadian Public Health Agency

Group Type ACTIVE_COMPARATOR

Standard Materials

Intervention Type BEHAVIORAL

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

Interventions

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Physical 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).

Intervention Type BEHAVIORAL

Standard Materials

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No