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.
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

July 20, 2011
August 6, 2011
August 2011
August 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01399359 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer
A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer

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.

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.

Observational
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1000
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August 2016   (final data collection date for primary outcome measure)

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
Female
35 Years and older
No
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NCT01399359
CDR0000702762, NSABP-DMP-1
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Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project
National Surgical Adjuvant Breast and Bowel Project (NSABP)
National Cancer Institute (NCI)
Principal Investigator: Christine Holmberg, PhD, MPH, MA National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigator: Angela Fagerlin, PhD University of Michigan Cancer Center
National Cancer Institute (NCI)
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP