Trial Information

Can Diet and Physical Activity Modulate Ovarian and Primary Peritoneal Cancer Progression-Free Survival?

OBJECTIVES:

Primary

- 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.

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 (Exploratory)

- 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.