Women's Activity and Lifestyle Study in Connecticut (WALC)
Impact of Exercise on Ovarian Cancer Prognosis
Study Overview
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- stage I-IV ovarian cancer
- less than 76 yrs of age
Exclusion Criteria:
- exercising
Study Plan
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 |
|---|---|
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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.
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Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.
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EXPERIMENTAL: exercise
Women randomized to exercise will receive telephone-counseling weekly for 6 months to increase their exercise
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Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from Baseline in Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
Time Frame: 6 months
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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
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6 months
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Change from Baseline in Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
Time Frame: 6 months
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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.
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6 months
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Change from Baseline in Short Form 36 (SF-36)
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Melinda Irwin, PhD, Yale University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- 0904004976
- R01CA138556 (NIH)
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