Exercise Information for Women With Cancer

Sponsor

Oregon Health and Science University (Other)

Overall Status

Completed

CT.gov ID

NCT03120819

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Oncologist Recommendation Behavioral: Oncologist Recommendation + DVD	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 x 3 repeated measures design with 2 groups and 3 time points2 x 3 repeated measures design with 2 groups and 3 time points

Masking:

Double (Care Provider, Investigator)

Masking Description:

Participant are randomized after receiving an exercise recommendation by their oncologist and thus oncologists are masked; however, study staff will administer survey questions including acceptability of the DVD and thus outcomes assessors are not masked

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Jul 31, 2011

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oncologist Recommendation only Medical providers in this study provide a standardized brief recommendation for exercise to a consenting patient during a clinical visit. Patients randomized to this arm receive a packet that contained a study information sheet and standard published exercise information materials. The standard materials consisted of publicly available exercise recommendations for cancer survivors from the American Cancer Society (ACS). The packet of exercise information intended to represent general information about exercise and cancer that would be readily available to patients through the internet, a medical clinic, or cancer support services.	Behavioral: Oncologist Recommendation Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist
Experimental: Oncologist Recommendation + DVD Participants in this arm receive the same oncologist's recommendation and written materials as the comparator group and also received an instructional yoga DVD. Inclusion of the video is intended to provide patients with a tool for following the oncologist's exercise recommendation. The instructional video contains a brief introduction from a breast cancer survivor, who was also featured in the exercise portion of the DVD, and safety information about lymphedema from a lymphedema therapist. The exercise program is a 30-minute, low intensity, restorative yoga program to improve whole body flexibility and to be safe for participants who were in active treatment for cancer and/or who had metastatic disease. Women are encouraged to use the DVD at least 3 times per week.	Behavioral: 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

Arm

Intervention/Treatment

Active Comparator: Oncologist Recommendation only

Medical providers in this study provide a standardized brief recommendation for exercise to a consenting patient during a clinical visit. Patients randomized to this arm receive a packet that contained a study information sheet and standard published exercise information materials. The standard materials consisted of publicly available exercise recommendations for cancer survivors from the American Cancer Society (ACS). The packet of exercise information intended to represent general information about exercise and cancer that would be readily available to patients through the internet, a medical clinic, or cancer support services.

Behavioral: Oncologist Recommendation

Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist

Experimental: Oncologist Recommendation + DVD

Participants in this arm receive the same oncologist's recommendation and written materials as the comparator group and also received an instructional yoga DVD. Inclusion of the video is intended to provide patients with a tool for following the oncologist's exercise recommendation. The instructional video contains a brief introduction from a breast cancer survivor, who was also featured in the exercise portion of the DVD, and safety information about lymphedema from a lymphedema therapist. The exercise program is a 30-minute, low intensity, restorative yoga program to improve whole body flexibility and to be safe for participants who were in active treatment for cancer and/or who had metastatic disease. Women are encouraged to use the DVD at least 3 times per week.

Behavioral: 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

Outcome Measures

Primary Outcome Measures

Change in Patient-Reported Fatigue [baseline, 4 and 8 weeks]
Fatigue will be measured with the Brief Profile of Mood States Fatigue subscale

Secondary Outcome Measures

Change in self-efficacy for exercise [baseline, 4 and 8 weeks]
Self-efficacy for exercise will be measured using the Self-Efficacy Assessment scale modified for exercise
Change in exercise readiness assessed by the Stage of Change for exercise [baseline, 4 and 8 weeks]
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
Change in self-report physical activity measured with the International Physical Activity Questionnaire [Baseline, 4 and 8 weeks]
We will measure changes in the reported time spent in physical activities per week

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OHSU School of Nursing	Portland	Oregon	United States	97239

Sponsors and Collaborators

Oregon Health and Science University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kerri Winters, Research Professor, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT03120819

Other Study ID Numbers:

IRB00005997

First Posted:

Apr 19, 2017

Last Update Posted:

Apr 19, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kerri Winters, Research Professor, Oregon Health and Science University

exercise

fatigue

physical activity

Study Results

No Results Posted as of Apr 19, 2017