NCT00230711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

November 30, 2012

Status Verified

September 1, 2005

Enrollment Period

5.2 years

First QC Date

September 29, 2005

Last Update Submit

November 29, 2012

Conditions

Breast Cancer

Keywords

Physical activityCancer follow-up care

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (1)

  • 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

    6 and 12 months for physical activity

Study Arms (2)

Exercise Counseling

EXPERIMENTAL
Behavioral: Physical activity counseling

Contact Control

PLACEBO COMPARATOR

Interventions

Physical activity counselingBEHAVIORAL
Exercise Counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centers for Behavioral and Preventive Medicine, Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • 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.

    PMID: 23730723DERIVED

  • Pinto BM, Dunsiger S, Waldemore M. Physical activity and psychosocial benefits among breast cancer patients. Psychooncology. 2013 Oct;22(10):2193-9. doi: 10.1002/pon.3272. Epub 2013 Mar 15.

    PMID: 23494869DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • Bernardine Pinto, Ph.D.

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2005

First Posted

October 3, 2005

Study Start

April 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

November 30, 2012

Record last verified: 2005-09

Locations

US(1)