Recruiting
Phase 2

Physical Activity

Sponsor:

Athabasca University

Code:

NCT01053468

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Physical Activity Resource Kit

Standard Materials

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT01053468

Start date

Aug, 2010

Status verified date

Jan, 2010

Completion date

Apr, 2013

Anticipated

Primary completion date

Apr, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: PA Behavior Intervention

Physical Activity Resource Kit

active comparator: Standard Materials

Receive physical activity handout from the Canadian Public Health Agency

Interventions

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).

Standard Materials

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

Primary outcome measure

  • Self-reported physical activity [ Time Frame: Baseline, post intervention, 6 months follow up ]

Central Contacts and Locations

Central contacts

Jeff Vallance, PhD

403-488-7179jeffv@athabascau.ca

Celeste Lavallee, BSc, RD

clavallee@athabascau.ca

Locations

Tom Baker Cancer Centre

Recruiting

Calgary, Alberta, Canada

Grande Prairie Cancer Centre

Recruiting

Grande Prairie, Alberta, Canada

Lethbridge Cancer Centre

Recruiting

Lethbridge, Alberta, Canada

Medicine Hat Cancer Centre

Recruiting

Medicine Hat, Alberta, Canada

Central Alberta Cancer Centre

Recruiting

Red Deer, Alberta, Canada

More Information

Sponsor

Athabasca University

Last update posted

Jul 1, 2011

Last verified

Jan, 2010

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Athabasca University on 2011-07-01.