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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2011 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01399359
First received: July 20, 2011
Last updated: August 6, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: telephone-based intervention
Drug: raloxifene
Drug: tamoxifen citrate
Other: communication analysis
Other: communication intervention
Other: counseling intervention
Other: educational intervention
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: psychosocial assessment and care

Study Type: Observational
Official Title: A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Factors hindering women from taking chemoprevention for breast cancer [ Designated as safety issue: No ]
  • Reasons for the choice of raloxifene vs tamoxifen among menopausal women [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2011
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399359

Sponsors and Collaborators
NSABP Foundation Inc
Investigators
Principal Investigator: Christine Holmberg, PhD, MPH, MA NSABP Foundation Inc
Investigator: Angela Fagerlin, PhD University of Michigan Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project
ClinicalTrials.gov Identifier: NCT01399359     History of Changes
Other Study ID Numbers: CDR0000702762, NSABP-DMP-1
Study First Received: July 20, 2011
Last Updated: August 6, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014