Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/EpidemiologyCompleted35 and overNCI, OtherNSABP-DMP-1
NCT01399359

Trial Description

Summary

RATIONALE: Learning about how patients make decisions about using chemoprevention may help doctors plan treatment in which more patients are willing to choose chemoprevention to reduce their breast cancer risk.

PURPOSE: This clinical trial studies factors influencing decision-making about the use of chemoprevention in women at increased risk for breast cancer.

Further Study Information

OBJECTIVES:

Primary

  • To describe the influence of social, environmental, and psychological factors (sociality of medication intake, life-events, understanding of prevention, clinical situation) on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents.

Secondary

  • To determine the implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women.
  • To determine what factors hinder women from taking chemoprevention for breast cancer.
  • To field test a questionnaire that identifies the factors that influence the decision-making process of women at increased risk of breast cancer for whom chemoprevention is a medically indicated option.
  • To describe the influence of social, environmental, and psychological factors on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents by menopausal status.
  • For postmenopausal women who decide to take a selective estrogen-receptor modulator (SERM) for breast cancer prevention, to assess reasons for the choice of raloxifene versus tamoxifen.

OUTLINE: This is a multicenter study.

Participants undergo a counseling session about their increased risk for breast cancer and the use of a selective estrogen-receptor modulator (SERM), tamoxifen citrate or raloxifene, to reduce breast cancer risk. Some participants may have their counseling session video-recorded. They are also asked to review the video with their interviewers and to be contacted for a brief follow-up telephone interview.

Participants then complete an initial questionnaire to assess recall and understanding of risk information given to them during the counseling session. This first questionnaire is completed preferably on the same day of counseling before leaving the clinic or office. Participants also have the option to take the questionnaire home and return it to the study site within 2 weeks. Participants who return the first questionnaire complete a second one before leaving the clinic or office, or receive it by mail with a returned self-addressed stamped envelope. Participants who indicate on the second questionnaire that they do not want to take a SERM are asked to complete an online questionnaire. Participants who have not made a decision about SERM use within 3 months after counseling are contacted by telephone. They also receive the second questionnaire by mail 3 months after the telephone contact.

Interviewers, doctors, or other health-care professionals also complete questionnaires that indicate what was discussed during counseling sessions.

Eligibility Criteria

Inclusion criteria

  • The participant must be female.
  • The participant must be greater than or equal to 35 years of age.
  • The participant must be English-speaking.
  • The participant must have been identified as being at increased risk for breast cancer as determined by the doctor/healthcare professional (HCP) . (Increased risk for breast cancer does not have to be based on a Gail score.)
  • During the participant's counseling session, breast cancer risk and the use of SERMs for breast cancer risk reduction must have been discussed, as reported by the doctor/HCP who conducted the session. Note: This criterion does not apply to participants who are asked before the counseling session to participate in the video recording component of DMP-1 at the selected NSABP sites.

Exclusion criteria

  • Previous invasive breast cancer of any type.
  • Previous history of ductal carcinoma in situ (DCIS).
  • Previous history of lobular carcinoma in situ (LCIS) if treated with mastectomy, radiation therapy, or endocrine therapy.
  • Participation in any other cancer prevention study involving pharmacologic intervention(s) or osteoporosis prevention study involving pharmacologic intervention(s).
  • Any history of or current tamoxifen, raloxifene, or other SERM therapy for any reason. (Participants are eligible if SERM use has been discussed prior to the counseling session as long as SERMs were never used.)

Trial Contact Information

Trial Lead Organizations/Sponsors

National Surgical Adjuvant Breast and Bowel Project

  • National Cancer Institute
Norman Wolmark, Principal Investigator

Trial Sites

U.S.A.

California
Oakland

Kaiser Permanente-Oakland

Christine Holmberg
Email: christine.holmberg@charite.de

Palo Alto

Stanford Cancer Center

Christine Holmberg
Email: christine.holmberg@charite.de

Santa Clara

Kaiser Permanente Medical Center - Santa Clara Homestead Campus

Christine Holmberg
Email: christine.holmberg@charite.de

Vallejo

Kaiser Permanente Medical Center - Vallejo

Christine Holmberg
Email: christine.holmberg@charite.de

Colorado
Colorado Springs

Memorial Hospital Cancer Center - Colorado Springs

Christine Holmberg
Email: christine.holmberg@charite.de

Delaware
Lewes

Tunnell Cancer Center at Beebe Medical Center

Christine Holmberg
Email: christine.holmberg@charite.de

Newark

Helen F. Graham Cancer Center at Christiana Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Florida
Lakeland

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Christine Holmberg
Email: christine.holmberg@charite.de

Idaho
Boise

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Christine Holmberg

Illinois
Decatur

Decatur Memorial Hospital Cancer Care Institute

Christine Holmberg
Email: christine.holmberg@charite.de

Elk Grove Village

Cancer Institute at Alexian Brothers

Christine Holmberg
Email: christine.holmberg@charite.de

Mount Vernon

Good Samaritan Regional Health Center

Christine Holmberg
Email: christine.holmberg@charite.de

Park Ridge

Advocate Lutheran General Cancer Care Center

Christine Holmberg
Email: christine.holmberg@charite.de

Springfield

Regional Cancer Center at Memorial Medical Center

Christine Holmberg
Email: christine.holmberg@charite.de

Urbana

Carle Cancer Center at Carle Foundation Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Christine Holmberg
Email: christine.holmberg@charite.de

Indiana
Elkhart

Michiana Hematology-Oncology, PC - Elkhart

Christine Holmberg
Email: christine.holmberg@charite.de

South Bend

CCOP - Northern Indiana CR Consortium

Christine Holmberg
Email: christine.holmberg@charite.de

Michiana Hematology-Oncology, PC - South Bend

Christine Holmberg
Email: christine.holmberg@charite.de

Iowa
Iowa City

Holden Comprehensive Cancer Center at University of Iowa

Christine Holmberg
Email: christine.holmberg@charite.de

Maryland
Bethesda

Suburban Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Massachusetts
Boston

Boston University Cancer Research Center

Christine Holmberg
Email: christine.holmberg@charite.de

Michigan
Ann Arbor

Saint Joseph Mercy Cancer Center

Christine Holmberg
Email: christine.holmberg@charite.de

Detroit

Van Elslander Cancer Center at St. John Hospital and Medical Center

Christine Holmberg
Email: christine.holmberg@charite.de

Grand Rapids

Butterworth Hospital at Spectrum Health

Christine Holmberg
Email: christine.holmberg@charite.de

CCOP - Grand Rapids

Christine Holmberg
Email: christine.holmberg@charite.de

Lacks Cancer Center at Saint Mary's Health Care

Christine Holmberg
Email: christine.holmberg@charite.de

Jackson

Gayle M. Jacob Cancer Center at Allegiance Health

Christine Holmberg
Email: christine.holmberg@charite.de

Livonia

St. Mary Mercy Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Muskegon

Mercy General Health Partners

Christine Holmberg

Pontiac

St. Joseph Mercy Oakland

Christine Holmberg

Port Huron

Mercy Regional Cancer Center at Mercy Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Saint Joseph

Lakeside Cancer Specialists, PLLC

Christine Holmberg
Email: christine.holmberg@charite.de

Minnesota
Brainerd

St. Joseph's Medical Center

Christine Holmberg
Email: christine.holmberg@charite.de

Burnsville

Fairview Ridges Hospital

Christine Holmberg

Coon Rapids

Mercy and Unity Cancer Center at Mercy Hospital

Christine Holmberg

Duluth

CCOP - Duluth

Christine Holmberg
Email: christine.holmberg@charite.de

Edina

Fairview Southdale Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Fridley

Mercy and Unity Cancer Center at Unity Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Minneapolis

Hennepin County Medical Center - Minneapolis

Christine Holmberg
Email: christine.holmberg@charite.de

Saint Louis Park

CCOP - Metro-Minnesota

Christine Holmberg
Email: christine.holmberg@charite.de

Park Nicollet Cancer Center

Christine Holmberg

Saint Paul

Regions Hospital Cancer Care Center

Christine Holmberg
Email: christine.holmberg@charite.de

United Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Stillwater

Lakeview Hospital

Christine Holmberg

Woodbury

Minnesota Oncology - Woodbury

Christine Holmberg
Email: christine.holmberg@charite.de

Missouri
Saint Louis

David C. Pratt Cancer Center at St. John's Mercy

Christine Holmberg
Email: christine.holmberg@charite.de

Springfield

Cancer Research for the Ozarks

Christine Holmberg
Email: christine.holmberg@charite.de

Hulston Cancer Center at Cox Medical Center South

Christine Holmberg
Email: christine.holmberg@charite.de

St. John's Regional Health Center

Christine Holmberg

Montana
Billings

Hematology-Oncology Centers of the Northern Rockies - Billings

Christine Holmberg

St. Vincent Healthcare Cancer Care Services

Christine Holmberg
Ph: 412-330-4600
Email: holmberc@mail.nih.gov

New Jersey
Camden

Cancer Institute of New Jersey at Cooper University Hospital - Camden

Christine Holmberg
Email: christine.holmberg@charite.de

New York
Manhasset

CCOP - North Shore University Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

New Hyde Park

Long Island Jewish Medical Center

Christine Holmberg

Monter Cancer Center of the North Shore-LIJ Health System

Christine Holmberg
Email: christine.holmberg@charite.de

North Carolina
Asheboro

Randolph Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Greensboro

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Statesville

Iredell Memorial Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Winston-Salem

Wake Forest University Comprehensive Cancer Center

Christine Holmberg
Email: christine.holmberg@charite.de

Ohio
Akron

McDowell Cancer Center at Akron General Medical Center

Christine Holmberg
Email: christine.holmberg@charite.de

Canton

Aultman Cancer Center at Aultman Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Tri-County Hematology/Oncology Associates, Incorporated

Christine Holmberg
Email: christine.holmberg@charite.de

Columbus

CCOP - Columbus

Christine Holmberg
Email: christine.holmberg@charite.de

Doctors Hospital at Ohio Health

Christine Holmberg
Email: christine.holmberg@charite.de

Grant Medical Center Cancer Care

Christine Holmberg
Email: christine.holmberg@charite.de

Riverside Methodist Hospital Cancer Care

Christine Holmberg
Email: christine.holmberg@charite.de

Newark

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Christine Holmberg

Portsmouth

Southern Ohio Medical Center Cancer Center

Christine Holmberg
Email: christine.holmberg@charite.de

Toledo

Toledo Clinic, Incorporated - Main Clinic

Christine Holmberg
Email: christine.holmberg@charite.de

University of Toledo Medical Center

Christine Holmberg

Oklahoma
Tulsa

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Pennsylvania
Bryn Mawr

Bryn Mawr Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Paoli

Cancer Center of Paoli Memorial Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Pittsburgh

National Surgical Adjuvant Breast and Bowel Project

Norman Wolmark
Ph: 412-330-4600
Email: joyce.mull@nsabp.org

Wynnewood

Lankenau Cancer Center at Lankenau Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

York

WellSpan Health

Christine Holmberg
Email: christine.holmberg@charite.de

South Carolina
Florence

McLeod Regional Medical Center

Christine Holmberg
Email: christine.holmberg@charite.de

Spartanburg

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Christine Holmberg
Email: christine.holmberg@charite.de

South Dakota
Sioux Falls

Avera Cancer Institute

Christine Holmberg
Email: christine.holmberg@charite.de

Texas
Houston

Dan L. Duncan Cancer Center at Baylor College of Medicine

Christine Holmberg
Email: christine.holmberg@charite.de

Methodist Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Univeristy of Texas M.D. Anderson Cancer Center

Christine Holmberg
Email: christine.holmberg@charite.de

Lubbock

Covenant Medical Center

Christine Holmberg
Email: christine.holmberg@charite.de

Temple

Scott and White Cancer Institute

Christine Holmberg
Email: christine.holmberg@charite.de

Vermont
Bennington

Southwestern Vermont Regional Cancer Center

Christine Holmberg
Email: christine.holmberg@charite.de

Virginia
Richmond

Virginia Commonwealth University Massey Cancer Center

Christine Holmberg
Email: christine.holmberg@charite.de

Washington
Seattle

CCOP - Virginia Mason Research Center

Christine Holmberg
Email: christine.holmberg@charite.de

Tacoma

CCOP - Northwest

Christine Holmberg

Wisconsin
Eau Claire

Marshfield Clinic Cancer Care at Regional Cancer Center

Christine Holmberg

Green Bay

St. Mary's Hospital Medical Center - Green Bay

Christine Holmberg
Email: christine.holmberg@charite.de

St. Vincent Hospital Regional Cancer Center

Christine Holmberg
Email: christine.holmberg@charite.de

Marshfield

Marshfield Clinic - Marshfield Center

Christine Holmberg
Email: christine.holmberg@charite.de

Milwaukee

Froedtert Hospital and Medical College of Wisconsin

Christine Holmberg
Email: christine.holmberg@charite.de

Minocqua

Marshfield Clinic - Lakeland Center

Christine Holmberg
Email: christine.holmberg@charite.de

Owosso

Great Lakes Cancer Institute - Owosso

Christine Holmberg
Email: christine.holmberg@charite.de

Rice Lake

Marshfield Clinic - Indianhead Center

Christine Holmberg
Email: christine.holmberg@charite.de

Stevens Point

Marshfield Clinic at Saint Michael's Hospital

Christine Holmberg
Email: christine.holmberg@charite.de

Weston

Marshfield Clinic - Weston Center

Christine Holmberg

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01399359
ClinicalTrials.gov processed this data on March 08, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.