Physical Activity Promotion in Cancer Follow-Up Care

This study has been completed.
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00230711
First received: September 29, 2005
Last updated: November 29, 2012
Last verified: September 2005

September 29, 2005
November 29, 2012
April 2004
June 2009   (final data collection date for primary outcome measure)
Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer.
Complete list of historical versions of study NCT00230711 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 6 and 12 months for physical activity ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
Physical Activity Promotion in Cancer Follow-Up Care
Physical Activity Promotion In Cancer Follow-up Care

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Breast Cancer
Behavioral: Physical activity counseling
  • Experimental: Exercise Counseling
    Intervention: Behavioral: Physical activity counseling
  • Placebo Comparator: Contact Control
Pinto BM, Papandonatos GD, Goldstein MG. A randomized trial to promote physical activity among breast cancer patients. Health Psychol. 2013 Jun;32(6):616-26. doi: 10.1037/a0029886.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
June 2009
June 2009   (final data collection date for primary outcome measure)

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:

-

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00230711
American Cancer Society, RSGP-03-423
Not Provided
The Miriam Hospital
The Miriam Hospital
Brown University
Principal Investigator: Bernardine Pinto, Ph.D. The Miriam Hospital
The Miriam Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP