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Physical Activity Promotion in Cancer Follow-Up Care

Physical Activity Promotion In Cancer Follow-up Care

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00230711
Enrollment
300
Registered
2005-10-03
Start date
2004-04-30
Completion date
2009-06-30
Last updated
2012-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Physical activity, Cancer follow-up care

Brief summary

This study aims at testing the efficacy of a physical activity (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.

Detailed description

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.

Interventions

BEHAVIORALPhysical activity counseling

Sponsors

Brown University
CollaboratorOTHER
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

\-

Design outcomes

Primary

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

Secondary

MeasureTime frame
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) at6 and 12 months for physical activity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026