Clinical trial NCT03120819: Exercise Information for Women With Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: exercise
fatigue
physical activity
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 x 3 repeated measures design with 2 groups and 3 time points
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient-Reported Fatigue
timeFrame: baseline, 4 and 8 weeks
Secondary outcomes:
measure: Change in self-efficacy for exercise
timeFrame: baseline, 4 and 8 weeks
measure: Change in exercise readiness assessed by the Stage of Change for exercise
timeFrame: baseline, 4 and 8 weeks
measure: Change in self-report physical activity measured with the International Physical Activity Questionnaire
timeFrame: Baseline, 4 and 8 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU School of Nursing
state: Oregon
Study officials:
References:
citation: Winters-Stone KM, Moe EL, Perry CK, Medysky M, Pommier R, Vetto J, Naik A. Enhancing an oncologist's recommendation to exercise to manage fatigue levels in breast cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Mar;26(3):905-912. doi: 10.1007/s00520-017-3909-z. Epub 2017 Sep 30.