Women's Activity and Lifestyle Study in Connecticut (WALC)

April 18, 2018 updated by: Yale University

Impact of Exercise on Ovarian Cancer Prognosis

Despite an increase in longevity, surviving ovarian cancer often brings an array of unpleasant side effects and compromises in QOL. Our proposed trial will be the first study to test whether exercise compared with attention control has a beneficial impact on quality of life, fitness and surrogate markers of ovarian cancer. Our trial could suggest a unique and important role for exercise in ovarian cancer care given that physical and functional aspects of QOL are often the most compromised in ovarian cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Currently, the American Cancer Society recommends a physically active lifestyle for cancer survivors to increase disease-free survival from cancer and other chronic diseases, and to improve quality of life. Studies of a strong benefit of physical activity on improving QOL following other types of cancer treatment, e.g., breast cancer, are well documented in the literature; yet very few studies of physical activity and QOL after a diagnosis of ovarian cancer have been published. Therefore, clinical trials of exercise on common physical and psychological consequences of ovarian cancer and its treatments are warranted.

The primary aims of our study are to examine, in 230 women who have completed treatment for Stage I-IV ovarian cancer, the impact of a moderate-intensity aerobic exercise intervention vs. attention control on:

  • Quality of Life
  • Body Composition (weight, BMI, total and % body fat, waist and hip circumference)
  • Hormones possibly associated with physical activity and ovarian cancer prognosis (insulin, IGF-I, IGF-II, IGF binding protein-3, CRP, leptin, estrone, estradiol, free estradiol, and sex-hormone binding globulin, osteopontin, MIF, prolactin, and CA-125)
  • Cardiorespiratory Fitness - an objective measure of functional capacity and adherence to exercise.

Hypotheses: Women randomized to exercise will experience improvements in quality of life, body composition, hormone levels, and cardiorespiratory fitness compared to women randomized to usual care.

Our trial could suggest a unique and important role for exercise in ovarian cancer care given that physical and functional aspects of QOL are often the most compromised in ovarian cancer patients.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • stage I-IV ovarian cancer
  • less than 76 yrs of age

Exclusion Criteria:

  • exercising

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: attention control
Women randomized to attention control will receive the same attention as women randomized to exercise intervention, i.e., weekly phone calls for 6 months. Each call is about 15 min. Women in the attention control will receive information on ovarian cancer health education topics.
Behavioral: Exercise
Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.
EXPERIMENTAL: exercise
Women randomized to exercise will receive telephone-counseling weekly for 6 months to increase their exercise
Behavioral: Exercise
Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
Time Frame: 6 months
The FACT-General (FACT-G) consists of four subscales that measure wellbeing in physical, social, emotional and functional domains. The FACT-Ovarian (FACT-O) is a disease-specific measure and is comprised of the four subscales from the FACT-G in addition to a set of items that address concerns specific to ovarian cancer
6 months
Change from Baseline in Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
Time Frame: 6 months
FACT-F is a self-reporting questionnaire comprised of 13 fatigue-related items. Each item on the FACT-F is answered on a five-point scale and summed, with total scores ranging between 0 and 52. Lower scores indicate greater self-reported fatigue.
6 months
Change from Baseline in Short Form 36 (SF-36)
Time Frame: 6 months
The SF-36 survey was interpreted using eight subscales (emotional, functional, pain, physical, roles-emotional, roles-physical, social, vitality) that can be combined into physical (PCS) and mental (MCS) component summary scores. The PCS score describes physical health and is composed of the general health, pain, physical functioning, and role-physical subscales. The MCS score describes mental health and is comprised of mental health, role-emotional, social functioning, and vitality subscales.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Melinda Irwin, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

April 3, 2014

First Posted (ESTIMATE)

April 8, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0904004976
  • R01CA138556 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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