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Physical Activity Promotion In Cancer Follow-up Care

Phase 3
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Physical Activity Promotion In Cancer Follow-up Care

Background: With improved survival rates, there are growing numbers of cancer survivors.
These individuals report impaired physical functioning, anxiety and depressed mood, fatigue,
and reduced quality of life after treatment. In addition, they may be at increased risk for
cardiovascular disease, obesity, osteoporosis and future cancers. Prior research has
demonstrated that moderate-intensity physical activity (PA) can improve enhance physical
functioning, reduce fatigue and improve vigor among cancer patients and those who have
completed medical treatments. These efforts have not been integrated with the healthcare
system. Data support the role of primary care providers in promoting PA among their
sedentary patients; the role of oncologists in encouraging patients to become physically
active has not been examined.

Objectives: This study aims at testing the efficacy of a PA intervention in an outpatient
oncology setting. We plan to compare Brief Advice for PA (MD advice plus contact control)
vs. Extended Advice (MD advice plus telephone-based PA counseling by research staff) over 3
months among 300 women who have completed treatment for breast cancer in the past 2 years.

Specific Aims: The primary aim is to examine the effects of oncologists' advice on PA plus
telephone counseling (Extended Advice) vs. oncologists' advice (Brief Advice) alone on
minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed
treatment for breast cancer.

Secondary aims include examining a) the effects of the two interventions on participants'
moderate-intensity PA at 6 and 12 months, b) the effects of the interventions on
participants' physical functioning, fatigue, vigor and quality of life (QOL) at 3, 6 and 12
months, and c) the acceptability of the interventions to the oncologists and the usefulness
of the interventions to patients.

Study Design: A randomized, controlled trial will be conducted in outpatient oncology
practices in Rhode Island. Within this setting, the oncologists and research staff will
offer a 3 month, theoretically-based intervention to increase moderate-intensity PA among
300 sedentary women aged 18 and older who attend cancer follow-up visits. The unit of
randomization will be at the patient level.

Cancer Relevance: If the data are promising, the study lays the groundwork for improving
cancer recovery by integrating a brief PA intervention into follow-up care for cancer
survivors. This study offers the potential to improve the follow-up care for cancer
survivors by encouraging them to becoming physically active, to help reduce the emotional
and physical side-effects of cancer and its treatment, as well as possibly reduce their risk
for other chronic diseases such as cardiovascular disease and osteoporosis.

Inclusion Criteria:

1) female aged >18 years, 2) completed primary and adjuvant treatment for breast cancer
(patients on hormone treatment such as Tamoxifen will be eligible). Women on chemotherapy
will become eligible 6 months after treatment completion, and will remain eligible up to
10 years posttreatment; 3) <10 years since treatment completion, 4) able to read and speak
English, 5) provide consent for medical chart review to extract disease and treatment
variables, 6) able to walk unassisted, are 7) sedentary defined as: currently not meeting
ACSM/CDC criteria (Pate et al, 1995) for moderate-intensity activity (>30 mins. per day on
>5 days per week) or vigorous-intensity activity (>20 mins. on >3 days per week), and 8)
have access to a telephone. -

Exclusion Criteria:


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Outcome Measure:

Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Bernardine Pinto, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Miriam Hospital


United States: Institutional Review Board

Study ID:

American Cancer Society



Start Date:

April 2004

Completion Date:

June 2009

Related Keywords:

  • Breast Cancer
  • Physical activity
  • Cancer follow-up care
  • Breast Neoplasms



Centers for Behavioral and Preventive Medicine, Miriam Hospital Providence, Rhode Island  02903