Women's Activity and Lifestyle Study in Connecticut (WALC)
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Cancer focused on measuring exercise, physical activity, ovarian cancer, quality of life, fatigue, weight
Eligibility Criteria
Inclusion Criteria:
- stage I-IV ovarian cancer
- less than 76 yrs of age
Exclusion Criteria:
- exercising
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
attention control
exercise
Arm Description
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.
Women randomized to exercise will receive telephone-counseling weekly for 6 months to increase their exercise
Outcomes
Primary Outcome Measures
Change from Baseline in Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
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)
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02107066
First Posted
May 17, 2012
Last Updated
April 18, 2018
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02107066
Brief Title
Women's Activity and Lifestyle Study in Connecticut
Acronym
WALC
Official Title
Impact of Exercise on Ovarian Cancer Prognosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
exercise, physical activity, ovarian cancer, quality of life, fatigue, weight
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
attention control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
exercise
Arm Type
Experimental
Arm Description
Women randomized to exercise will receive telephone-counseling weekly for 6 months to increase their exercise
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.
Primary Outcome Measure Information:
Title
Change from Baseline in Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
Description
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
Time Frame
6 months
Title
Change from Baseline in Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
Description
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.
Time Frame
6 months
Title
Change from Baseline in Short Form 36 (SF-36)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stage I-IV ovarian cancer
less than 76 yrs of age
Exclusion Criteria:
exercising
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda Irwin, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Women's Activity and Lifestyle Study in Connecticut
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