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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedNatural history/EpidemiologyApproved-not yet active35 and overNCI, OtherCDR0000702762
NSABP-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

DISEASE CHARACTERISTICS:

  • Participant must have been identified as being at increased risk for breast cancer as determined by the doctor/health-care 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 selective estrogen-receptor modulators (SERMs) for breast cancer risk reduction must have been discussed, as reported by the doctor/HCP who conducted the session
  • 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 National Surgical Adjuvant Breast and Bowel Project (NSABP) sites
  • No prior invasive breast cancer of any type
  • No history of ductal carcinoma in situ (DCIS)
  • No history of lobular cancer in situ (LCIS) if treated with mastectomy, radiotherapy, or endocrine therapy
  • Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

  • Any menopausal status eligible
  • Participant must be English-speaking

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No history of or concurrent tamoxifen, raloxifene, or other selective estrogen receptor modulator (SERM) therapy for any reason
  • No participation in any other cancer-prevention study or osteoporosis-prevention study involving pharmacologic interventions

Trial Contact Information

Trial Lead Organizations/Sponsors

National Surgical Adjuvant Breast and Bowel Project

National Cancer Institute

Christine HolmbergPrincipal Investigator

Angela Fagerlin

Trial Sites

U.S.A.
California
  Oakland
 Kaiser Permanente-Oakland
 Christine Holmberg
  Email: christine.holmberg@charite.de
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Christine Holmberg
  Email: christine.holmberg@charite.de
  Stanford
 Stanford Cancer Center
 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
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 Identifer NCT01399359
Information obtained from ClinicalTrials.gov on November 20, 2012

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.