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Trial record 1 of 1 for:    NSABP DMP-1
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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
  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: Counseling session
Other: Questionnaire 1
Other: Questionnaire 2
Other: online questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 NSABP Foundation Inc:

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 [ Time Frame: Measured at start of study and at 3 to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1023
Study Start Date: August 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women who decide not to take a SERM
Women participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire.
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 to take a SERM
Women participate in the counseling session, questionnaire 1 and questionnaire 2.
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.

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
Sampling Method:   Non-Probability Sample
Study Population

Women at increased risk for breast cancer.

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.)
  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

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
NSABP Foundation Inc
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc
  More Information

Additional Information:
No publications provided

Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT01399359     History of Changes
Other Study ID Numbers: NSABP-DMP-1, NSABP-DMP-1
Study First Received: July 20, 2011
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NSABP Foundation Inc:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014