Exercise Information for Women With Cancer

NCT03120819 | Completed

• 1 other identifier: IRB00005997
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

exercise; fatigue; physical activity

Outcome Measures

Primary Outcomes (1)

• Change in Patient-Reported Fatigue

  Fatigue will be measured with the Brief Profile of Mood States Fatigue subscale

  baseline, 4 and 8 weeks

Secondary Outcomes (3)

• Change in self-efficacy for exercise

  baseline, 4 and 8 weeks

• Change in exercise readiness assessed by the Stage of Change for exercise

  baseline, 4 and 8 weeks

• Change in self-report physical activity measured with the International Physical Activity Questionnaire

  Baseline, 4 and 8 weeks

Study Arms (2)

Oncologist Recommendation only

ACTIVE COMPARATOR

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

Oncologist Recommendation + DVD

EXPERIMENTAL

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

Interventions

Oncologist Recommendation BEHAVIORAL

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

Oncologist Recommendation only

Oncologist Recommendation + DVD BEHAVIORAL

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

Oncologist Recommendation + DVD

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not medically cleared to participate in low-intensity exercise

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU School of Nursing

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 28965138 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: 2 x 3 repeated measures design with 2 groups and 3 time points

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 19, 2017
• Study Start: August 1, 2010
• Primary Completion: July 31, 2011
• Study Completion: April 1, 2017
• Last Updated: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)