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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02107066
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE May 17, 2012
First Posted Date  ICMJE April 8, 2014
Last Update Posted Date April 20, 2018
Study Start Date  ICMJE May 2009
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Women's Activity and Lifestyle Study in Connecticut
Official Title  ICMJE Impact of Exercise on Ovarian Cancer Prognosis
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Behavioral: Exercise
Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Exercise
  • Experimental: exercise
    Women randomized to exercise will receive telephone-counseling weekly for 6 months to increase their exercise
    Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2014)		 144
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • exercising
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02107066
Other Study ID Numbers  ICMJE 0904004976
R01CA138556 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yale University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yale University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Melinda Irwin, PhD Yale University
PRS Account Yale University
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP