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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
NSABP Foundation Inc
ClinicalTrials.gov Identifier:
NCT01399359
First received: July 20, 2011
Last updated: September 25, 2014
Last verified: September 2014

July 20, 2011
September 25, 2014
August 2011
September 2014   (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 [ Time Frame: Measured at start of study and at 3 to 6 months ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT01399359 on ClinicalTrials.gov Archive Site
  • Factors hindering women from taking chemoprevention for breast cancer [ Time Frame: Measured at start of study and at 3 to 6 months ] [ Designated as safety issue: No ]
  • Reasons for the choice of raloxifene vs tamoxifen among menopausal women [ Time Frame: Measured at start of study and at 3 to 6 months ] [ Designated as safety issue: No ]
  • The implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women. [ Time Frame: Measured at start of study and at 3 to 6 months ] [ Designated as safety issue: No ]
  • To 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. [ Time Frame: Measured at start of study and at 3 to 6 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Measured at start of study and at 3 to 6 months ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Women at increased risk for breast cancer.

Breast Cancer
  • Behavioral: Counseling session
  • Other: Questionnaire 1
    Questionnaire 1 assesses the recall and understanding of risk information given during the counseling session.
  • Other: Questionnaire 2
    Questionnaire 2 focuses on what factors, other thana the numerical risk-benefit analysis of SERM intake, are important in the decision-making process of women at increased risk for breast cancer.
  • Other: online questionnaire
  • Women who decide not to take a SERM
    Women participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire.
    Interventions:
    • Behavioral: Counseling session
    • Other: Questionnaire 1
    • Other: Questionnaire 2
    • Other: online questionnaire
  • Women who decide to take a SERM
    Women participate in the counseling session, questionnaire 1 and questionnaire 2.
    Interventions:
    • Behavioral: Counseling session
    • Other: Questionnaire 1
    • Other: Questionnaire 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1023
September 2014
September 2014   (final data collection date for primary outcome measure)

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.)
Female
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01399359
NSABP-DMP-1, NSABP-DMP-1
No
NSABP Foundation Inc
NSABP Foundation Inc
National Cancer Institute (NCI)
Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc
NSABP Foundation Inc
September 2014

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