• 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 ]

RATIONALE: A healthy lifestyle and counseling 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 in patients with previously treated stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.

OBJECTIVES:

Primary

• To determine if patients who are disease-free after successfully completing primary and potential consolidation/maintenance therapy for stage III or IV ovarian epithelial 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.

Secondary

• 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.

Tertiary

• To explore the potential of six blood markers (leptin, prolactin, osteopontin, insulin-like growth factor II, CA-125, and macrophage stimulating factor) for predicting progression or death.
• To explore the potential for leptin, prolactin, osteopontin, insulin-like growth factor II, CA-125, macrophage stimulating factor, individually or in combination, to predict recurrence or survival.
• To assess plasma carotenoid levels at baseline, 6, 12, 18 and 24 months in a random subsample of the study population to estimate compliance with the healthy lifestyle intervention and to potentially explore the relationship between carotenoid exposure and progression-free survival in patients with ovarian cancer.
• To examine patient compliance with the healthy lifestyle intervention and to assess which types of patients are more likely to be compliant.
• 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 this intervention on bowel functioning as measured by the GSRS-IBS subscales.

OUTLINE: This is a multicenter study. Participants are stratified according to stage of disease at diagnosis (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 counseling, receive educational materials and counseling focused on how to read food labels to estimate grams of fat per serving and serving size, and undergo telephone counseling by a lifestyle intervention counselor 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 daily fat gram and step diaries 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. Heigh, weight, body mass index, and waist circumference are measured periodically during study. Participants undergo blood collection at baseline and at 6, 12, 18, and 24 months. Plasma samples are assessed for total carotenoid, alpha and beta-carotene, lutein, lycopene and beta-cryptoxanthin concentrations.

• Ovarian Cancer
• Peritoneal Cavity Cancer

• Behavioral: behavioral dietary intervention
• Behavioral: compliance monitoring
• Behavioral: exercise intervention
• Other: counseling intervention
• Other: educational intervention
• Other: laboratory biomarker analysis
• Other: questionnaire administration
• Procedure: quality-of-life assessment

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial cancer or primary peritoneal carcinoma, including any of the following subtypes:

  • Serous adenocarcinoma
  • Endometrioid adenocarcinoma
  • Mucinous adenocarcinoma
  • Undifferentiated carcinoma
  • Clear cell adenocarcinoma
  • Mixed epithelial carcinoma
  • Transitional cell carcinoma
  • Malignant Brenner's tumor
  • Adenocarcinoma not otherwise specified
• Stage III or IV disease
• No prior diagnosis of or treatment for stage I or II ovarian epithelial or primary peritoneal cancer

• Patients must have completed all primary chemotherapy and consolidation therapy (if administered) more than 12 weeks ago but less than 24 months ago and are in complete remission

  • Consolidation therapy is defined as any chemotherapy or biological therapy used for a patient who has completed at least four courses of primary chemotherapy and had documented complete remission prior to initiation of such chemotherapy or biological therapy
  • A patient may have received prior consolidation therapy for up to 12 months

• No clinical evidence of persistent or recurrent disease based on CA 125 level and CT scan

  • All patients must have had an abnormally elevated serum CA 125 level prior to surgery or chemotherapy that has normalized to < 35 units/mL prior to study entry

PATIENT CHARACTERISTICS:

• GOG performance status 0-2
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Creatinine ≤ 1.5 times upper limit normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Willing to provide names and appropriate telephone contact information and to be contacted periodically via telephone by Arizona Diet, Behavior and Quality of Life Shared Service staff for completion of individualized lifestyle intervention counseling
• Life expectancy ≥ 1 year
• Body Mass Index ≥ 20 kg/m^2
• No history of other invasive malignancies within the past 5 years, except for nonmelanoma skin cancer
• More than 24 months since prior marathon, triathlon, or other endurance-related physical activity

• No other chronic disease that would preclude randomization into a lifestyle intervention trial including, but are not limited to, any of the following:

  • Recent myocardial infarction or unstable angina (within the past 6 months)
  • Chronic hepatitis
  • Rheumatoid disease
  • Renal or hepatic disease or dysfunction
  • Diabetics receiving insulin
• No vegans
• No ongoing medically prescribed diet or physical activity regimen that has lasted for 6 months or longer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics