Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Purpose
This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.
Conditions
- Fallopian Tube Clear Cell Adenocarcinoma
- Fallopian Tube Endometrioid Adenocarcinoma
- Fallopian Tube Mucinous Adenocarcinoma
- Fallopian Tube Serous Adenocarcinoma
- Fallopian Tube Transitional Cell Carcinoma
- Malignant Ovarian Brenner Tumor
- Ovarian Clear Cell Adenocarcinoma
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Mucinous Adenocarcinoma
- Ovarian Seromucinous Carcinoma
- Ovarian Serous Adenocarcinoma
- Ovarian Transitional Cell Carcinoma
- Primary Peritoneal Serous Adenocarcinoma
- Stage IIA Fallopian Tube Cancer AJCC v6 and v7
- Stage IIA Ovarian Cancer AJCC V6 and v7
- Stage IIB Fallopian Tube Cancer AJCC v6 and v7
- Stage IIB Ovarian Cancer AJCC v6 and v7
- Stage IIC Fallopian Tube Cancer AJCC v6 and v7
- Stage IIC Ovarian Cancer AJCC v6 and v7
- Stage IIIA Fallopian Tube Cancer AJCC v7
- Stage IIIA Ovarian Cancer AJCC v6 and v7
- Stage IIIA Primary Peritoneal Cancer AJCC v7
- Stage IIIB Fallopian Tube Cancer AJCC v7
- Stage IIIB Ovarian Cancer AJCC v6 and v7
- Stage IIIB Primary Peritoneal Cancer AJCC v7
- Stage IIIC Fallopian Tube Cancer AJCC v7
- Stage IIIC Ovarian Cancer AJCC v6 and v7
- Stage IIIC Primary Peritoneal Cancer AJCC v7
- Stage IV Fallopian Tube Cancer AJCC v6 and v7
- Stage IV Ovarian Cancer AJCC v6 and v7
- Stage IV Primary Peritoneal Cancer AJCC v7
- Undifferentiated Fallopian Tube Carcinoma
- Undifferentiated Ovarian Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis - 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?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 adenocarcinoma - 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; 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 (chemo) or biological therapy - Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 (per the institution?s upper limit of normal) and computed tomography (CT) scan or magnetic resonance imaging (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) - Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2 - Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen - 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.) - 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), or a history of an eating disorder (anorexia nervosa or bulimia nervosa) - Patients must complete all pre-entry assessments - Patients must have signed an approved informed consent and authorization permitting release of personal health information - 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 patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC
Exclusion Criteria
- Patients with GOG performance grade of 3 or 4 - Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus - Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction) - Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma - Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago - Patients with a life expectancy of less than one year - Patients with body mass index (BMI) < 20 kg/m^2 - Vegan vegetarians - Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue - Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months - Patients who have had surgery for weight loss - Note: women will not be excluded if their baseline lifestyle assessment indicates a healthy eating and moderate physical activity with the exception of the exclusion criteria above
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Group I (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 twice a week for 4 weeks, then weekly for 2 weeks, twice a month for 5 months, monthly for the subsequent 6 months, and then once every other month for 12 months. Participants complete daily fat gram and step diaries at least three times per week. |
|
Active Comparator Group II (observation) |
Participants receive a study notebook containing general study-related information. Participants are not asked to record diet or physical activity but are provided a single sample diary in their study notebook. Participants receive telephone contact on a sliding scale similar to the intervention group, but at less frequent intervals (22 versus 33 calls over the course of the intervention). |
|
Recruiting Locations
Birmingham, Alabama 35233
Anchorage, Alaska 98508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks, Alaska 99701
John A. Keech
907-458-5380
Phoenix, Arizona 85004
John H. Farley
623-207-3000
Tucson, Arizona 85719
Janiel M. Cragun
800-327-2873
Tucson, Arizona 85724
Janiel M. Cragun
520-626-9008
Hot Springs, Arkansas 71913
Mehmet S. Copur
501-622-2100
Little Rock, Arkansas 72205
Kristin K. Zorn
501-686-8274
Auburn, California 95602
Auburn, California 95603
Berkeley, California 94704
Burbank, California 91505
Burlingame, California 94010
Cameron Park, California 95682
Castro Valley, California 94546
Stacy D. D'Andre
510-537-1234
Concord, California 94520
Babak Edraki
925-674-2580
Davis, California 95616
John K. Chan
877-827-3222
Duarte, California 91010
Fremont, California 94538
Irvine, California 92618
Scott E. Lentz
626-564-3455
La Jolla, California 92093
Los Angeles, California 90027
Scott E. Lentz
626-564-3455
Los Angeles, California 90048
Bobbie J. Rimel
310-423-8965
Los Angeles, California 90095
Robin Farias-Eisner
888-798-0719
Modesto, California 95355
Mountain View, California 94040
Mountain View, California 94040
Orange, California 92868
Michael L. Berman
562-933-0900
Palo Alto, California 94301
Roseville, California 95661
Roseville, California 95661
Sacramento, California 95816
San Diego, California 92103
San Francisco, California 94115
Santa Cruz, California 95065
Santa Rosa, California 95403
Sunnyvale, California 94086
Vacaville, California 95687
Vallejo, California 94589
Aurora, Colorado 80012
Aurora, Colorado 80045
Saketh R. Guntupalli
720-848-0650
Boulder, Colorado 80301
Boulder, Colorado 80304
Colorado Springs, Colorado 80907
Mehmet S. Copur
501-622-2100
Colorado Springs, Colorado 80907
Mehmet S. Copur
501-622-2100
Denver, Colorado 80210
Mehmet S. Copur
501-622-2100
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80218
Denver, Colorado 80220
Denver, Colorado 80220
Denver, Colorado 80222
Durango, Colorado 81301
Mehmet S. Copur
501-622-2100
Durango, Colorado 81301
Englewood, Colorado 80113
Englewood, Colorado 80113
Fort Collins, Colorado 80524
Diana C. Medgyesy
970-297-6150
Golden, Colorado 80401
Mehmet S. Copur
501-622-2100
Greeley, Colorado 80631
Lakewood, Colorado 80228
Mehmet S. Copur
501-622-2100
Lakewood, Colorado 80228
Mehmet S. Copur
501-622-2100
Littleton, Colorado 80120
Littleton, Colorado 80122
Mehmet S. Copur
501-622-2100
Lone Tree, Colorado 80124
Longmont, Colorado 80501
Mehmet S. Copur
501-622-2100
Longmont, Colorado 80501
Mehmet S. Copur
501-622-2100
Loveland, Colorado 80539
Parker, Colorado 80138
Mehmet S. Copur
501-622-2100
Parker, Colorado 80138
Mehmet S. Copur
501-622-2100
Pueblo, Colorado 81004
Mehmet S. Copur
501-622-2100
Pueblo, Colorado 81008
Mehmet S. Copur
501-622-2100
Thornton, Colorado 80260
Mehmet S. Copur
501-622-2100
Wheat Ridge, Colorado 80033
Bridgeport, Connecticut 06606
Farmington, Connecticut 06030
Molly A. Brewer
800-579-7822
Hartford, Connecticut 06105
Elena S. Ratner
203-785-5702
Middletown, Connecticut 06457
New Haven, Connecticut 06520
Elena S. Ratner
203-785-5702
Lewes, Delaware 19958
Mark E. Borowsky
302-733-6227
Newark, Delaware 19713
Mark E. Borowsky
302-733-6227
Newark, Delaware 19713
Mark E. Borowsky
302-733-6227
Newark, Delaware 19713
Mark E. Borowsky
302-733-6227
Newark, Delaware 19713
Mark E. Borowsky
302-733-6227
Newark, Delaware 19718
Mark E. Borowsky
302-733-6227
Rehoboth Beach, Delaware 19971
Mark E. Borowsky
302-733-6227
Seaford, Delaware 19973
Mark E. Borowsky
302-733-6227
Wilmington, Delaware 19801
Mark E. Borowsky
302-733-6227
Orlando, Florida 32803
Sarasota, Florida 34239
James V. Fiorica
941-917-2225
Atlanta, Georgia 30342
Guilherme Henrique C. Cantuaria
404-303-3355
Augusta, Georgia 30912
Decatur, Georgia 30033
Savannah, Georgia 31405
Honolulu, Hawaii 96813
Michael E. Carney
808-586-2979
Honolulu, Hawaii 96813
Michael E. Carney
808-586-2979
Honolulu, Hawaii 96813
Michael E. Carney
808-586-2979
Honolulu, Hawaii 96826
Michael E. Carney
808-586-2979
Boise, Idaho 83706
Philip J. Stella
734-712-4673
Boise, Idaho 83712
Caldwell, Idaho 83605
J. R. Liu
208-367-7954
Coeur d'Alene, Idaho 83814
Emmett, Idaho 83617
J. R. Liu
208-367-7954
Fruitland, Idaho 83619
Meridian, Idaho 83642
J. R. Liu
208-367-7954
Meridian, Idaho 83642
Nampa, Idaho 83686
J. R. Liu
208-367-7954
Nampa, Idaho 83686
Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Twin Falls, Idaho 83301
Aurora, Illinois 60504
Bloomington, Illinois 61704
James L. Wade
309-243-3605
Canton, Illinois 61520
James L. Wade
309-243-3605
Carbondale, Illinois 62902
James L. Wade
309-243-3605
Carthage, Illinois 62321
James L. Wade
309-243-3605
Centralia, Illinois 62801
James L. Wade
309-243-3605
Chicago, Illinois 60611
Chicago, Illinois 60612
Chicago, Illinois 60637
John W. Moroney
773-834-7424
Danville, Illinois 61832
Decatur, Illinois 62526
James L. Wade
309-243-3605
Decatur, Illinois 62526
James L. Wade
309-243-3605
Effingham, Illinois 62401
Effingham, Illinois 62401
James L. Wade
309-243-3605
Eureka, Illinois 61530
James L. Wade
309-243-3605
Galesburg, Illinois 61401
James L. Wade
309-243-3605
Galesburg, Illinois 61401
James L. Wade
309-243-3605
Hinsdale, Illinois 60521
Kewanee, Illinois 61443
James L. Wade
309-243-3605
Macomb, Illinois 61455
James L. Wade
309-243-3605
Mattoon, Illinois 61938
Maria T. Grosse-Perdekamp
217-258-5900
New Lenox, Illinois 60451
John W. Moroney
773-834-7424
Ottawa, Illinois 61350
James L. Wade
309-243-3605
Pekin, Illinois 61554
James L. Wade
309-243-3605
Pekin, Illinois 61554
James L. Wade
309-243-3605
Peoria, Illinois 61603
James L. Wade
309-243-3605
Peoria, Illinois 61615
James L. Wade
309-243-3605
Peoria, Illinois 61615
James L. Wade
309-243-3605
Peoria, Illinois 61637
James L. Wade
309-243-3605
Peru, Illinois 61354
James L. Wade
309-243-3605
Peru, Illinois 61354
James L. Wade
309-243-3605
Princeton, Illinois 61356
James L. Wade
309-243-3605
Springfield, Illinois 62702
James L. Wade
309-243-3605
Springfield, Illinois 62702
James L. Wade
309-243-3605
Springfield, Illinois 62781
James L. Wade
309-243-3605
Swansea, Illinois 62226
James L. Wade
309-243-3605
Urbana, Illinois 61801
Maria T. Grosse-Perdekamp
800-446-5532
Urbana, Illinois 61801
Maria T. Grosse-Perdekamp
800-446-5532
Yorkville, Illinois 60560
Indianapolis, Indiana 46202
Jeanne M. Schilder
317-630-7808
Indianapolis, Indiana 46260
South Bend, Indiana 46628
Michael W. Method
574-237-1328
Clive, Iowa 50325
Mehmet S. Copur
501-622-2100
Clive, Iowa 50325
Mehmet S. Copur
501-622-2100
Council Bluffs, Iowa 51503
Mehmet S. Copur
501-622-2100
Creston, Iowa 50801
Mehmet S. Copur
501-622-2100
Des Moines, Iowa 50314
Mehmet S. Copur
501-622-2100
Des Moines, Iowa 50314
Mehmet S. Copur
501-622-2100
West Des Moines, Iowa 50266
Mehmet S. Copur
501-622-2100
Chanute, Kansas 66720
Shaker R. Dakhil
316-268-5374
Dodge City, Kansas 67801
Shaker R. Dakhil
316-268-5374
El Dorado, Kansas 67042
Shaker R. Dakhil
316-268-5374
Fort Scott, Kansas 66701
Shaker R. Dakhil
316-268-5374
Independence, Kansas 67301
Shaker R. Dakhil
316-268-5374
Kansas City, Kansas 66160
Kingman, Kansas 67068
Shaker R. Dakhil
316-268-5374
Lawrence, Kansas 66044
Shaker R. Dakhil
316-268-5374
Liberal, Kansas 67905
Shaker R. Dakhil
316-268-5374
Manhattan, Kansas 66502
Shaker R. Dakhil
316-268-5374
McPherson, Kansas 67460
Shaker R. Dakhil
316-268-5374
Newton, Kansas 67114
Shaker R. Dakhil
316-268-5374
Parsons, Kansas 67357
Shaker R. Dakhil
316-268-5374
Prairie Village, Kansas 66208
Pratt, Kansas 67124
Shaker R. Dakhil
316-268-5374
Salina, Kansas 67401
Shaker R. Dakhil
316-268-5374
Wellington, Kansas 67152
Shaker R. Dakhil
316-268-5374
Wichita, Kansas 67208
Shaker R. Dakhil
316-268-5374
Wichita, Kansas 67208
Shaker R. Dakhil
316-268-5374
Wichita, Kansas 67214
Shaker R. Dakhil
316-268-5374
Wichita, Kansas 67214
Shaker R. Dakhil
316-268-5374
Wichita, Kansas 67214
Shaker R. Dakhil
316-268-5374
Winfield, Kansas 67156
Shaker R. Dakhil
316-268-5374
Bardstown, Kentucky 40004
Mehmet S. Copur
501-622-2100
Corbin, Kentucky 40701
Mehmet S. Copur
501-622-2100
Edgewood, Kentucky 41017
Lexington, Kentucky 40504
Mehmet S. Copur
501-622-2100
Lexington, Kentucky 40509
Mehmet S. Copur
501-622-2100
Lexington, Kentucky 40536
Frederick R. Ueland
859-257-3379
London, Kentucky 40741
Louisville, Kentucky 40202
Mehmet S. Copur
501-622-2100
Louisville, Kentucky 40215
Mehmet S. Copur
501-622-2100
Louisville, Kentucky 40245
Mehmet S. Copur
501-622-2100
Shepherdsville, Kentucky 40165
Mehmet S. Copur
501-622-2100
Baton Rouge, Louisiana 70817
Portland, Maine 04102
Christopher J. Darus
207-885-7565
Scarborough, Maine 04074
Christopher J. Darus
207-885-7565
Baltimore, Maryland 21204
Paul Celano
443-849-3706
Bethesda, Maryland 20889-5600
Chad A. Hamilton
301-319-2100
Boston, Massachusetts 02111
Burlington, Massachusetts 01805
Corrine L. Zarwan
781-744-8027
Ann Arbor, Michigan 48106
Philip J. Stella
734-712-4673
Battle Creek, Michigan 49017
Brighton, Michigan 48114
J. R. Liu
208-367-7954
Brighton, Michigan 48114
J. R. Liu
208-367-7954
Canton, Michigan 48188
J. R. Liu
208-367-7954
Canton, Michigan 48188
J. R. Liu
208-367-7954
Caro, Michigan 48723
J. R. Liu
208-367-7954
Chelsea, Michigan 48118
J. R. Liu
208-367-7954
Chelsea, Michigan 48118
J. R. Liu
208-367-7954
Clarkston, Michigan 48346
J. R. Liu
208-367-7954
Clarkston, Michigan 48346
J. R. Liu
208-367-7954
Dearborn, Michigan 48124
J. R. Liu
208-367-7954
Detroit, Michigan 48236
Philip J. Stella
734-712-4673
East China Township, Michigan 48054
J. R. Liu
208-367-7954
Flint, Michigan 48503
J. R. Liu
208-367-7954
Flint, Michigan 48503
J. R. Liu
208-367-7954
Flint, Michigan 48503
Philip J. Stella
734-712-4673
Flint, Michigan 48503
Philip J. Stella
734-712-4673
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grosse Pointe Woods, Michigan 48236
J. R. Liu
208-367-7954
Grosse Pointe Woods, Michigan 48236
J. R. Liu
208-367-7954
Grosse Pointe Woods, Michigan 48236
J. R. Liu
208-367-7954
Kalamazoo, Michigan 49007
Lansing, Michigan 48912
Philip J. Stella
734-712-4673
Livonia, Michigan 48154
J. R. Liu
208-367-7954
Livonia, Michigan 48154
Philip J. Stella
734-712-4673
Macomb, Michigan 48044
J. R. Liu
208-367-7954
Macomb, Michigan 48044
J. R. Liu
208-367-7954
Marlette, Michigan 48453
J. R. Liu
208-367-7954
Muskegon, Michigan 49444
Niles, Michigan 49120
Pontiac, Michigan 48341
J. R. Liu
208-367-7954
Pontiac, Michigan 48341
J. R. Liu
208-367-7954
Pontiac, Michigan 48341
J. R. Liu
208-367-7954
Pontiac, Michigan 48341
Philip J. Stella
734-712-4673
Reed City, Michigan 49677
Rochester Hills, Michigan 48309
J. R. Liu
208-367-7954
Saginaw, Michigan 48601
Philip J. Stella
734-712-4673
Saginaw, Michigan 48604
J. R. Liu
208-367-7954
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Sterling Heights, Michigan 48312
J. R. Liu
208-367-7954
Tawas City, Michigan 48764
J. R. Liu
734-712-3671
Traverse City, Michigan 49684
Warren, Michigan 48088
J. R. Liu
208-367-7954
Warren, Michigan 48093
J. R. Liu
208-367-7954
Warren, Michigan 48093
J. R. Liu
208-367-7954
Warren, Michigan 48093
J. R. Liu
208-367-7954
Warren, Michigan 48093
J. R. Liu
208-367-7954
Warren, Michigan 48093
Philip J. Stella
734-712-4673
West Branch, Michigan 48661
J. R. Liu
208-367-7954
Wyoming, Michigan 49519
Ypsilanti, Michigan 48106
J. R. Liu
208-367-7954
Ypsilanti, Michigan 48197
J. R. Liu
208-367-7954
Bemidji, Minnesota 56601
Maria C. Bell
218-333-5000
Burnsville, Minnesota 55337
Coon Rapids, Minnesota 55433
Edina, Minnesota 55435
Fridley, Minnesota 55432
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55454
New Ulm, Minnesota 56073
Robbinsdale, Minnesota 55422
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Shakopee, Minnesota 55379
Stillwater, Minnesota 55082
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Wyoming, Minnesota 55092
Jackson, Mississippi 39216
Donald P. Seago
601-200-3300
Bonne Terre, Missouri 63628
James L. Wade
309-243-3605
Cape Girardeau, Missouri 63703
James L. Wade
309-243-3605
Cape Girardeau, Missouri 63703
James L. Wade
309-243-3605
Jefferson City, Missouri 65109
James L. Wade
309-243-3605
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Saint Louis, Missouri 63131
James L. Wade
309-243-3605
Sainte Genevieve, Missouri 63670
James L. Wade
309-243-3605
Springfield, Missouri 65807
Jay W. Carlson
888-221-4849
Sullivan, Missouri 63080
James L. Wade
309-243-3605
Sunset Hills, Missouri 63127
James L. Wade
309-243-3605
Anaconda, Montana 59711
Billings, Montana 59101
Billings, Montana 59102
Benjamin T. Marchello
800-648-6274
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Helena, Montana 59601
Kalispell, Montana 59901
Missoula, Montana 59802
Missoula, Montana 59804
Grand Island, Nebraska 68803
Mehmet S. Copur
501-622-2100
Kearney, Nebraska 68845
Mehmet S. Copur
501-622-2100
Kearney, Nebraska 68847
Mehmet S. Copur
501-622-2100
Lincoln, Nebraska 68510
Mehmet S. Copur
501-622-2100
Omaha, Nebraska 68114
Peter C. Morris
402-354-5144
Omaha, Nebraska 68122
Mehmet S. Copur
501-622-2100
Omaha, Nebraska 68122
Mehmet S. Copur
501-622-2100
Omaha, Nebraska 68124
Mehmet S. Copur
501-622-2100
Omaha, Nebraska 68130
Mehmet S. Copur
501-622-2100
Omaha, Nebraska 68131
Mehmet S. Copur
501-622-2100
Papillion, Nebraska 68046
Mehmet S. Copur
501-622-2100
Las Vegas, Nevada 89169
Dover, New Hampshire 03820
Henry L. Sonneborn
603-740-2150
Lebanon, New Hampshire 03756
Manchester, New Hampshire 03102
Nashua, New Hampshire 03063
Camden, New Jersey 08103
David P. Warshal
856-325-6757
Mount Holly, New Jersey 08060
Randolph B. Deger
609-914-6762
Voorhees, New Jersey 08043
David P. Warshal
856-325-6757
Voorhees, New Jersey 08043
Randolph B. Deger
609-914-6762
Manhasset, New York 11030
Mineola, New York 11501
Eva Chalas
516-663-3115
New Hyde Park, New York 11040
New Hyde Park, New York 11040
New York, New York 10021
Stony Brook, New York 11794
Michael L. Pearl
800-862-2215
Syracuse, New York 13210
Mary J. Cunningham
315-464-5476
Asheboro, North Carolina 27203
Vinay K. Gudena
336-832-0821
Asheville, North Carolina 28816
Burlington, North Carolina 27215
Vinay K. Gudena
336-832-0821
Chapel Hill, North Carolina 27599
Charlotte, North Carolina 28204
John M. McDonald
704-384-5369
Charlotte, North Carolina 28207
John M. McDonald
704-342-9577
Charlotte, North Carolina 28262
Durham, North Carolina 27710
Laura J. Havrilesky
888-275-3853
Greensboro, North Carolina 27403
Vinay K. Gudena
336-832-0821
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
John M. McDonald
704-384-5369
Huntersville, North Carolina 28078
Kernersville, North Carolina 27284
Joshua S. Trinidad
336-277-8887
Matthews, North Carolina 28105
Mebane, North Carolina 27302
Vinay K. Gudena
336-832-0821
Mooresville, North Carolina 28117
John M. McDonald
704-799-3946
Mount Airy, North Carolina 27030
Joshua S. Trinidad
336-277-8887
Pinehurst, North Carolina 28374
John W. Byron
910-715-2200
Reidsville, North Carolina 27320
Vinay K. Gudena
336-832-0821
Thomasville, North Carolina 27360
Joshua S. Trinidad
336-277-8887
Wilkesboro, North Carolina 28659
Joshua S. Trinidad
336-277-8887
Winston-Salem, North Carolina 27103
Joshua S. Trinidad
336-277-8887
Winston-Salem, North Carolina 27103
Joshua S. Trinidad
336-277-8887
Bismarck, North Dakota 58501
Maria C. Bell
218-333-5000
Fargo, North Dakota 58122
Maria C. Bell
218-333-5000
Fargo, North Dakota 58122
Maria C. Bell
218-333-5000
Fargo, North Dakota 58122
Maria C. Bell
218-333-5000
Belpre, Ohio 45714
Canton, Ohio 44710
Michael P. Hopkins
888-293-4673
Chillicothe, Ohio 45601
Cincinnati, Ohio 45220
Mehmet S. Copur
501-622-2100
Cincinnati, Ohio 45242
Mehmet S. Copur
501-622-2100
Cincinnati, Ohio 45247
Mehmet S. Copur
501-622-2100
Cincinnati, Ohio 45255
Mehmet S. Copur
501-622-2100
Cleveland, Ohio 44111
Peter G. Rose
866-223-8100
Cleveland, Ohio 44195
Peter G. Rose
866-223-8100
Columbus, Ohio 43210
Columbus, Ohio 43213
Columbus, Ohio 43214
Columbus, Ohio 43214
Columbus, Ohio 43215
Columbus, Ohio 43219
Columbus, Ohio 43222
Delaware, Ohio 43015
Delaware, Ohio 43015
Delaware, Ohio 43015
Lancaster, Ohio 43130
Mansfield, Ohio 44903
Marietta, Ohio 45750
Marion, Ohio 43302
Mayfield Heights, Ohio 44124
Peter G. Rose
866-223-8100
Mount Vernon, Ohio 43050
Newark, Ohio 43055
Newark, Ohio 43055
Portsmouth, Ohio 45662
Westerville, Ohio 43081
Zanesville, Ohio 43701
Oklahoma City, Oklahoma 73104
Tulsa, Oklahoma 74146
Baker City, Oregon 97814
J. R. Liu
208-367-7954
Bend, Oregon 97701
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Newberg, Oregon 97132
Ontario, Oregon 97914
J. R. Liu
208-367-7954
Portland, Oregon 97213
Portland, Oregon 97225
Abington, Pennsylvania 19001
Mark S. Shahin
215-481-2402
Allentown, Pennsylvania 18103
Philip J. Stella
734-712-4673
Bethlehem, Pennsylvania 18015
Bethlehem, Pennsylvania 18017
Philip J. Stella
734-712-4673
Danville, Pennsylvania 17822
Radhika P. Gogoi
570-271-5251
Gettysburg, Pennsylvania 17325
Mark A. Miller
877-441-7957
Hazleton, Pennsylvania 18201
Radhika P. Gogoi
570-271-5251
Monroeville, Pennsylvania 15146
Thomas C. Krivak
877-284-2000
Natrona Heights, Pennsylvania 15065
Thomas C. Krivak
877-284-2000
Philadelphia, Pennsylvania 19104
Robert A. Burger
800-474-9892
Philadelphia, Pennsylvania 19107
Robert A. Burger
800-474-9892
Pittsburgh, Pennsylvania 15224
Thomas C. Krivak
877-284-2000
Pittsburgh, Pennsylvania 15232
Alexander B. Olawaiye
412-647-8073
Scranton, Pennsylvania 18510
Radhika P. Gogoi
570-271-5251
State College, Pennsylvania 16801
Radhika P. Gogoi
570-271-5251
West Chester, Pennsylvania 19380
William E. Luginbuhl
610-431-5297
Wexford, Pennsylvania 15090
Thomas C. Krivak
877-284-2000
Wilkes-Barre, Pennsylvania 18711
Radhika P. Gogoi
570-271-5251
York, Pennsylvania 17403
Mark A. Miller
877-441-7957
Providence, Rhode Island 02905
Paul A. DiSilvestro
401-274-1122
Charleston, South Carolina 29425
Whitney S. Graybill
843-792-9321
Easley, South Carolina 29640
Jeffrey W. Elder
864-679-3966
Gaffney, South Carolina 29341
Carlton L. Schwab
800-486-5941
Greenville, South Carolina 29605
Jeffrey W. Elder
864-679-3966
Greenville, South Carolina 29605
Jeffrey W. Elder
864-679-3966
Greenville, South Carolina 29615
Jeffrey W. Elder
864-679-3966
Greer, South Carolina 29650
Jeffrey W. Elder
864-679-3966
Greer, South Carolina 29651
Carlton L. Schwab
800-486-5941
Seneca, South Carolina 29672
Jeffrey W. Elder
864-679-3966
Spartanburg, South Carolina 29303
Carlton L. Schwab
800-486-5941
Spartanburg, South Carolina 29307
Jeffrey W. Elder
864-679-3966
Sioux Falls, South Dakota 57104
Maria C. Bell
218-333-5000
Sioux Falls, South Dakota 57117-5134
Maria C. Bell
218-333-5000
Chattanooga, Tennessee 37404
Mehmet S. Copur
501-622-2100
Hixson, Tennessee 37343
Mehmet S. Copur
501-622-2100
Knoxville, Tennessee 37920
Larry C. Kilgore
865-544-9773
Nashville, Tennessee 37236
Michael P. Stany
301-319-2100
Ooltewah, Tennessee 37363
Mehmet S. Copur
501-622-2100
Bryan, Texas 77802
Fort Sam Houston, Texas 78234
Caela R. Miller
210-916-4837
Houston, Texas 77030
Karen H. Lu
713-792-3245
Houston, Texas 77030
Aparna A. Kamat
713-790-2700
Houston, Texas 77070
Aparna A. Kamat
713-790-2700
Sugar Land, Texas 77479
Aparna A. Kamat
713-790-2700
American Fork, Utah 84003
Craig R. Nichols
253-403-2394
Cedar City, Utah 84720
Craig R. Nichols
253-403-2394
Farmington, Utah 84025
Logan, Utah 84321
Craig R. Nichols
253-403-2394
Murray, Utah 84107
Craig R. Nichols
253-403-2394
Ogden, Utah 84403
Craig R. Nichols
253-403-2394
Provo, Utah 84604
Craig R. Nichols
253-403-2394
Saint George, Utah 84770
Craig R. Nichols
253-403-2394
Salt Lake City, Utah 84106
Craig R. Nichols
253-403-2394
Salt Lake City, Utah 84112
Salt Lake City, Utah 84143
Craig R. Nichols
253-403-2394
Charlottesville, Virginia 22908
Susan C. Modesitt
859-257-3379
Portsmouth, Virginia 23708-2197
Andrew S. Camarata
757-953-5939
Richmond, Virginia 23298
Sarah M. Temkin
804-200-7062
Roanoke, Virginia 24016
Janet L. Osborne
540-985-8510
Aberdeen, Washington 98520
Auburn, Washington 98001
John A. Keech
907-458-5380
Bainbridge Island, Washington 98110
John A. Keech
907-458-5380
Bellevue, Washington 98004
John A. Keech
907-458-5380
Bellingham, Washington 98225
Burien, Washington 98166
Centralia, Washington 98531
Edmonds, Washington 98026
Enumclaw, Washington 98022
Mehmet S. Copur
501-622-2100
Everett, Washington 98201
Federal Way, Washington 98002
John A. Keech
907-458-5380
Federal Way, Washington 98003
Mehmet S. Copur
501-622-2100
Gig Harbor, Washington 98332
John A. Keech
907-458-5380
Gig Harbor, Washington 98335
John A. Keech
907-458-5380
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Lakewood, Washington 98499
Mehmet S. Copur
501-622-2100
Longview, Washington 98632
Lynnwood, Washington 98036
John A. Keech
907-458-5380
Mount Vernon, Washington 98273
Heidi J. Gray
425-899-3181
Mount Vernon, Washington 98274
Heidi J. Gray
425-899-3181
Port Townsend, Washington 98368
John A. Keech
907-458-5380
Poulsbo, Washington 98370
John A. Keech
907-458-5380
Puyallup, Washington 98372
John A. Keech
907-458-5380
Puyallup, Washington 98372
John A. Keech
907-458-5380
Seattle, Washington 98101
John A. Keech
907-458-5380
Seattle, Washington 98104
Seattle, Washington 98107
Seattle, Washington 98109
Heidi J. Gray
425-899-3181
Seattle, Washington 98109
Heidi J. Gray
425-899-3181
Seattle, Washington 98112
Seattle, Washington 98122-4307
Seattle, Washington 98122-5711
Seattle, Washington 98133
Heidi J. Gray
425-899-3181
Seattle, Washington 98133
Heidi J. Gray
425-899-3181
Seattle, Washington 98195
Heidi J. Gray
425-899-3181
Shelton, Washington 98584
Spokane Valley, Washington 99216
Spokane, Washington 99204
Spokane, Washington 99208
Heidi J. Gray
425-899-3181
Spokane, Washington 99216
Spokane, Washington 99218
Tacoma, Washington 97405
John A. Keech
907-458-5380
Tacoma, Washington 98405
Mehmet S. Copur
501-622-2100
Tacoma, Washington 98405
John A. Keech
907-458-5380
Tacoma, Washington 98405
Mehmet S. Copur
501-622-2100
Tacoma, Washington 98405
John A. Keech
253-403-2394
Tacoma, Washington 98405
John A. Keech
907-458-5380
Vancouver, Washington 98664
Walla Walla, Washington 99362
Wenatchee, Washington 98801
Heidi J. Gray
425-899-3181
Yelm, Washington 98597
Morgantown, West Virginia 26505
Jamie L. Lesnock
304-598-6560
Burlington, Wisconsin 53105
Elizabeth L. Dickson Michelson
414-649-5717
Chippewa Falls, Wisconsin 54729
Anthony C. Evans
800-347-0673
Eau Claire, Wisconsin 54701
Anthony C. Evans
800-924-8515
Fond Du Lac, Wisconsin 54937
Elizabeth L. Dickson Michelson
414-649-5717
Germantown, Wisconsin 53022
Elizabeth L. Dickson Michelson
414-649-5717
Grafton, Wisconsin 53024
Elizabeth L. Dickson Michelson
414-649-5717
Green Bay, Wisconsin 54301-3526
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54311
Elizabeth L. Dickson Michelson
414-649-5717
Kenosha, Wisconsin 53142
Elizabeth L. Dickson Michelson
414-649-5717
La Crosse, Wisconsin 54601
Ladysmith, Wisconsin 54848
Anthony C. Evans
800-347-0673
Madison, Wisconsin 53792
David M. Kushner
800-622-8922
Manitowoc, Wisconsin 54221
Marinette, Wisconsin 54143
Marinette, Wisconsin 54143
Elizabeth L. Dickson Michelson
414-649-5717
Marshfield, Wisconsin 54449
Anthony C. Evans
800-347-0673
Milwaukee, Wisconsin 53209
Elizabeth L. Dickson Michelson
414-649-5717
Milwaukee, Wisconsin 53215
Elizabeth L. Dickson Michelson
414-649-5717
Milwaukee, Wisconsin 53226
William H. Bradley
414-805-4380
Milwaukee, Wisconsin 53233
Elizabeth L. Dickson Michelson
414-649-5717
Minocqua, Wisconsin 54548
Anthony C. Evans
800-347-0673
New Richmond, Wisconsin 54017
Oshkosh, Wisconsin 54904
Elizabeth L. Dickson Michelson
414-649-5717
Racine, Wisconsin 53406
Elizabeth L. Dickson Michelson
414-649-5717
Rice Lake, Wisconsin 54868
Anthony C. Evans
800-347-0673
Sheboygan, Wisconsin 53081
Elizabeth L. Dickson Michelson
414-649-5717
Stevens Point, Wisconsin 54482
Summit, Wisconsin 53066
Elizabeth L. Dickson Michelson
414-649-5717
Two Rivers, Wisconsin 54241
Elizabeth L. Dickson Michelson
414-649-5717
Wausau, Wisconsin 54401
Anthony C. Evans
800-347-0673
Wauwatosa, Wisconsin 53226
Elizabeth L. Dickson Michelson
414-649-5717
West Allis, Wisconsin 53227
Elizabeth L. Dickson Michelson
414-649-5717
Weston, Wisconsin 54476
Anthony C. Evans
800-347-0673
Wisconsin Rapids, Wisconsin 54494
Anthony C. Evans
800-347-0673
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
More Details
- NCT ID
- NCT00719303
- Status
- Unknown status
- Sponsor
- Gynecologic Oncology Group
Detailed Description
PRIMARY OBJECTIVES: I. To determine if women who are disease-free after successfully completing primary and potential consolidation/maintenance, therapy for stage II-IV ovarian, fallopian tube or primary peritoneal cancer and who are randomized to a healthy lifestyle intervention, will have significantly increased progression-free survival compared to similar women who are randomized to a usual care comparison group. SECONDARY OBJECTIVES: I. To determine if women who are randomized to the study intervention will have improved general quality of life as measured by the General Health subscale of Research and Development (RAND) 36-Item Health Survey (RAND-36). II. To determine if women who are randomized to the study intervention will have improved physical and bowel functioning as measured by the Physical Functioning subscale of RAND-36 and the Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS), compared to women who are randomized to usual care. TERTIARY OBJECTIVES: I. To assess patient compliance with the healthy lifestyle intervention by analyzing biomarkers (e.g., total carotenoid) at baseline, 6, 12, and 24 months. II. To explore the relationship between carotenoid exposure and progression free survival from ovarian cancer. III. 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. IV. 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. V. To explore the impact of the intervention on bowel functioning as measured with the GSRS-IBS subscales. VI. To assess the association between subjectively measured sleep duration/quality (using the Pittsburgh Sleep Quality Scale), anthropometric measurements, and self-reported dietary energy intake among women previously treated for stage II-IV ovarian or primary peritoneal cancer. VII. To assess and compare telomere length and rate of telomere shortening between ovarian cancer survivors randomized to lifestyle intervention versus standard of care. VIII. To assess effects of the intervention on biomarkers of metabolic health as measured by changes in circulating insulin and related insulin resistance, lipids and inflammation. IX. To determine if the intervention effect on the biomarkers listed above is modified by baseline central adiposity. X. To determine if the intervention effect on biomarkers listed above is mediated by change in central adiposity. XI. To evaluate changes in central adiposity using computerized tomography (CT) scan data from regularly scheduled, routine surveillance CT scans to determine if change in CT-specific visceral adiposity is associated with changes in biomarkers of metabolic deregulation and inflammation in a random subsample. OUTLINE: 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 twice a week for 4 weeks, then weekly for 2 weeks, twice a month for 5 months, monthly for the subsequent 6 months, and then once every other month for 12 months. Participants complete daily fat gram and step diaries at least three times per week. GROUP 2 (COMPARISON LIFESTYLE): Participants receive a study notebook containing general study-related information. Participants are not asked to record diet or physical activity but are provided a single sample diary in their study notebook. Participants receive telephone contact on a sliding scale similar to the intervention group, but at less frequent intervals (22 versus 33 calls over the course of the intervention). After completion of study, participants are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.