Exercise Information for Women With Cancer

Cancer Clinical Trial

Official title:

A Randomized Controlled Trial to Determine the Effect of Supplementing an Oncologist's Recommendation to Exercise With Multimedia on Fatigue Levels in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120819
• Other study ID #: IRB00005997
• Status: Completed
• Phase: N/A
• First received: April 12, 2017
• Last updated: April 14, 2017
• Start date: August 1, 2010
• Est. completion date: April 1, 2017

Study information

• Verified date: April 2017
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fatigue is a troublesome symptom for breast cancer patients, which might be mitigated with exercise. Cancer patients often prefer their oncologist recommend an exercise program, yet a recommendation alone may not be enough to change behavior. Our study will determine whether adding an exercise DVD to an oncologist's recommendation to exercise led to better outcomes than a recommendation alone.

Description:

Purpose: Controlled, intervention trials suggest that exercise may be a useful strategy to manage symptoms and side effects associated with cancer treatment. However, practical programs that facilitate exercise engagement among cancer patients are few and have been insufficiently studied. Medical providers may be best suited to deliver exercise information because of their frequent patient contact and the trust that patients place in their advice; however, unless sufficient resources are supplied in conjunction with verbal advice, patients may be less likely to successfully follow their physician's advice. The addition of an easy-to-follow, cancer specific exercise instructional video (DVD) to a provider's recommendation to exercise may provide patients with the motivation and ability to increase physical activity. We propose a feasibility study that will 1) determine acceptance and use of a provider-disseminated instructional home-exercise DVD among female cancer patients treated at OHSU and 2) determine if this cancer specific home-based DVD exercise program leads to greater decreases in fatigue, increases in exercise motivation and in physical activity compared to a standard exercise recommendation only among breast cancer patients treated at OHSU (N=100).

Methods: Medical providers who see female cancer patients during routine clinical visits will be approached to participate in the study. Willing providers will be enlisted to consent patients to receive a brief conversation (2-3 minutes) about the importance of exercise in their cancer care and then ask whether or not patients are willing to receive more information about the study from study staff. Providers will inform study staff about consenting participants who will then be randomized to one of two groups in the order that they enrolled. Study staff will then contact participants by phone to further explain the study and confirm eligibility then ask questions about their treatment, symptoms, and physical activity history. Based on their randomly assigned group, participants will receive either a control packet of standard exercise information based on guidelines from the American Cancer Society or standard exercise information plus a cancer specific home-based exercise DVD program. Fatigue, motivation for exercise, physical activity and use / acceptability of exercise information (+/- DVD) will be reassessed at 4 and 8 weeks following enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: April 1, 2017
• Est. primary completion date: July 31, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of breast cancer

• Scheduled for a clinical appointment with a surgical, radiation or medical oncologist at Oregon Health & Science University (OHSU)

• Capable of answering survey questions by phone

Exclusion Criteria:

• Not medically cleared to participate in low-intensity exercise

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Oncologist Recommendation
Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist
• Oncologist Recommendation + DVD
Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist and then be sent an instructional exercise DVD to follow at their home three times per week for eight weeks

Locations

Country	Name	City	State
United States	OHSU School of Nursing	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient-Reported Fatigue	Fatigue will be measured with the Brief Profile of Mood States Fatigue subscale	baseline, 4 and 8 weeks
Secondary	Change in self-efficacy for exercise	Self-efficacy for exercise will be measured using the Self-Efficacy Assessment scale modified for exercise	baseline, 4 and 8 weeks
Secondary	Change in exercise readiness assessed by the Stage of Change for exercise	We will measure a person's readiness to engage in recommended levels of physical activity using the Stage of Change for behavior change modified for exercise	baseline, 4 and 8 weeks
Secondary	Change in self-report physical activity measured with the International Physical Activity Questionnaire	We will measure changes in the reported time spent in physical activities per week	Baseline, 4 and 8 weeks