Diet and Physical Activity Change or Usual Care in Improving Survival in Patients With Previously Treated Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
RATIONALE: A healthy lifestyle and counseling (coaching) after treatment may improve progression-free survival in patients with previously treated cancer.
PURPOSE: This randomized phase III trial is studying diet and physical activity changes to see how well they work compared with usual care in improving progression-free survival of patients with previously treated stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Behavioral: behavioral dietary intervention
Behavioral: compliance monitoring
Behavioral: exercise intervention
Behavioral: telephone-based intervention
Other: counseling intervention
Other: educational intervention
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Masking: Open Label
|Official Title:||Can Diet and Physical Activity Modulate Ovarian and Primary Peritoneal Cancer Progression-Free Survival?|
- Progression-free survival [ Designated as safety issue: No ]
- Improved quality of life and physical function [ Designated as safety issue: No ]
- Blood markers in predicting progression or death [ Designated as safety issue: No ]
- Blood markers in predicting recurrence or survival [ Designated as safety issue: No ]
- Plasma carotenoid levels [ Designated as safety issue: No ]
- Patient compliance [ Designated as safety issue: No ]
- Impact on other aspects of quality of life [ Designated as safety issue: No ]
- Impact on bowel function [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
- To determine if patients who are disease-free after successfully completing primary and potential consolidation/maintenance therapy for stage II, III, or IV ovarian epithelial, fallopian tube, or primary peritoneal cancer and who are randomized to a healthy lifestyle intervention, will have significantly increased progression-free survival when compared with similar patients who are randomized to usual care.
- To determine if patients who are randomized to the study intervention will have improved general quality of life as measured by the General Health subscale of RAND-36 and physical functioning as measured by the Physical Functioning subscale of RAND-36 and the GSRS-IBS when compared with women who are randomized to usual care.
- To perform a pilot assessment at baseline and at 6-, 12-, and 24-month dietary biomarkers in a sub-sample of the study population to estimate compliance with the healthy lifestyle intervention and to explore the relationship between carotenoid exposure and progression-free survival from ovarian cancer.
- To examine patient compliance with the healthy lifestyle intervention and to assess which types of patients are more likely to be compliant with the healthy lifestyle intervention and whether progression-free survival is better among compliant individuals.
- To explore the impact of the intervention on other aspects of quality of life such as: pain, role limitations due to physical health and emotional problems, mental health, vitality, and social functioning as measured by the corresponding subscales of the RAND-36.
- To explore the impact of the intervention on bowel functioning as measured with the GSRS-IBS subscales.
OUTLINE: This is a multicenter study. Participants are stratified according to stage of disease at diagnosis (II vs III vs IV) and presence or absence of maintenance/consolidation therapy following primary treatment. Participants are randomized to 1 of 2 groups.
- Group 1 (lifestyle intervention): Participants receive a dietary intervention designed to promote increased levels of plasma carotenoids, control weight, and to ensure adequacy of micronutrient intake. Participants also undergo a physical activity intervention comprising a moderately low aerobic regimen to raise the usual activity level. Participants also undergo face-to-face coaching, receive educational materials and coaching focused on how to read food labels to estimate grams of fat per serving and serving size, and undergo telephone coaching by a lifestyle-intervention coach once a week for 4 weeks, then twice a month for 6 months, monthly for the subsequent 6 months, and then once every other month for 11 months. Participants complete a daily Lifestyle Journal: fat gram and step diary at least three times per week.
- Group 2 (comparison lifestyle): Participants receive a blue study notebook containing general study-related information. Participants receive telephone contact every six months focusing on general health status.
All participants complete baseline questionnaires including demographic and lifestyle information, medical history, and a comprehensive assessment of risk factors for ovarian cancer. The Arizona Food Frequency Questionnaire and repeat 24-hour recalls are used to measure dietary intake. Participants also complete physical activity assessments using the Arizona Physical Activity Questionnaire and quality-of-life assessments using the RAND-36 and GSRS-IBS. Height, weight, body mass index, and waist circumference are measured periodically during study. Participants undergo blood collection at baseline and at 6, 12, and 24 months. Plasma samples are assessed for total carotenoid, alpha and beta-carotene, lutein, lycopene, and beta-cryptoxanthin concentrations.
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|Study Chair:||David S. Alberts, MD||University of Arizona|
|Principal Investigator:||Philip J. DiSaia, MD||Gynecologic Oncology Group|