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

Athabasca University

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Behavioral: Physical Activity Resource Kit; Behavioral: Standard Materials

Study type: Interventional

Funder types: Other

Identifiers

NCT01053468

PROACTIVE

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

PA Behavior Intervention

Experimental group

Description:

Physical Activity Resource Kit

Treatment:

Behavioral: Physical Activity Resource Kit

Standard Materials

Active Comparator group

Description:

Receive physical activity handout from the Canadian Public Health Agency

Treatment:

Behavioral: Standard Materials