Study ID
STU 012013-026

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital
  • Parkland Health & Hospital System

Annette Paulsen

Principal Investigator
David Miller, M.D.


This study is a randomized, multi-centers, non-blinded, Phase iii clinical trial of the effectiveness of a high vegetable content diet combined with daily physical activity for a period of two years, to increase progression-free survival among women with Stage ii-iV ovarian cancer with no evidence of disease following first-line chemotherapy or first line plus maintenance/consolidation therapy.

During the study:
* Ca-125 will be measured every 3 months by the treating physician.
* Physical exam every 3 months which will include blood pressure, waist circumference and weight check.
* Height will be measured every 12 months while on study.
* MRi or CT scan will be performed only if clinically indicated by the treating physician.

in addition, the participants will also be asked to complete a series of questionnaires on food intake, physical activity, quality of life, and general health throughout the study.

* Baseline Questionnaire - Collects general information on your health, age, ethnicity, and lifestyle.

* arizona Food Frequency Questionnaire (aFFQ) x This questionnaire contains 153 items related to the participant diet and food intake and she will be asked to report the food she has eaten during the last three months.

* arizona Physical activity Questionnaire (aPaQ) x This questionnaire contains 59 items and looks at your level of exercise.

* RanD-36 x This questionnaire is a tool designed to evaluate overall physical functioning ability.

* GSRS-iBS x This questionnaire is designed to evaluate bowel symptoms.

* Pittsburgh Sleep Quality index (PSQi) x This questionnaire is designed to assess the overall quality of sleep.

The participants will be [Quote]randomized[Quote] into one of the study groups as follows:
Group 1:
* Participate in coaching phone calls on a sliding scale frequency (more phone calls in the Beginning, tapering down to few calls toward the end of the study); in all 22 coaching call sessions will be completed over the 2 year duration of the study.
* at the beginning of the study participant will be mailed study related materials. These will include
a pedometer and/or accelerometer which can be used to track how many steps she takes per day and a coaching binder which will be used to assist her during coaching phone calls. Participant will also receive printed materials throughout the study to provide her with general health information.

Group 2:
* Complete regularly scheduled lifestyle intervention coaching sessions that will be conducted over the telephone with a lifestyle coach from the study coordinating center at The university of arizona Cancer Center in Tucson, arizona. Telephone coaching will begin within one week of initial introduction coaching call by a study coordinator and will then continue on a twice weekly schedule for the first 4 weeks, then once per week for 2 weeks, then 2 times per month for five months, then one time per month for 6 months and then every other month for the remainder of the study. Participant can request an adjustment in the frequency of the telephone counseling if needed to meet and sustain the study diet and physical activity goals.

* Complete a daily lifestyle journal that will track daily fat grams and steps. These diaries will be provided in the form of a pocket-sized calendar. Participant will be asked to record servings of vegetables and fruits and fat grams eaten on a provided weekly checklist as well as steps taken on select days. Participant will be able to track the amount of steps she takes by using the pedometer and/or accelerometer provided to her through this study. Participant may complete the diary each and every day throughout the study, but at minimum she will be asked to complete the diary 3 times per week throughout the study. Lifestyle journals will be mailed back to the arizona Cancer Center in pre-addressed and stamped envelope on a monthly basis.

Participant Eligibility

3.11 Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube
or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis.
3.12 Patients with the following histologic epithelial cell types are eligible: serous
adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,
undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial
carcinoma, transitional cell carcinoma, malignant Brenner[Single Quote]s Tumor or
adenocarcinoma not otherwise specified (N.O.S.). However, the histologic
features of the tumor must be compatible with a primary M[?]llerian epithelial
3.13 Patients must have completed all primary chemotherapy and consolidation
therapy (if administered) at least 6 weeks, and no more than 6 months and 2
weeks, prior to enrollment and must be in complete remission. (02/19/13)
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 chemo or biological therapy.
3.14 Patients must have achieved a documented complete response to treatment
based on normal CA-125 and CT scan or MRI with contrast (i.e. there must be
no clinical evidence of persistent or recurrent disease based on CA-125 and CT
scan or MRI with contrast). (02/19/13)
3.15 Patients must have a GOG Performance Grade of 0, 1, or 2.
3.16 Patients must not be currently enrolled in an ongoing (participating for 6 months
or longer) medically prescribed diet or physical activity regimen.
3.17 Patients must have no other chronic disease that would preclude randomization
into a lifestyle intervention trial. Such diseases include recent myocardial
infarction or unstable angina (in the previous 6 months), chronic hepatitis,
rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving
insulin; or other clinical condition limiting ability to walk (recent leg fracture,
significant osteoarthritis, related orthopedic conditions, degenerative
neurological conditions, etc).
3.18 Patients must not have a serious psychiatric illness (e.g. lifetime bipolar
disorder, schizophrenia or other psychosis, serious personality disorder, severe
major depressive disorder or recent suicide or psychiatric hospitalization
(previous 12 months).
3.19 Patients must complete all pre-entry assessments as outlined in Section 7.1.
3.110 Patients must have signed an approved informed consent and authorization
permitting release of personal health information.
3.111 Patients must be willing to provide name and appropriate telephone contact
information and be willing to be contacted periodically via telephone by The
University of Arizona Cancer Center (AZCC) staff for completion of
individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patientcompleted responses if necessary. Patient must be willing to have AFFQ,
APAQ, Baseline Questionnaire, and personal contact information sent to AZCC.
3.112 Only women 18 years and older are eligible. (02/19/13)