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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399359
• Other study ID #: NSABP-DMP-1
• Secondary ID: NSABP-DMP-1
• Status: Completed
• Start date: August 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2021
• Source: NSABP Foundation Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1023
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 120 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Counseling session

Other:
• Questionnaire 1
Questionnaire 1 assesses the recall and understanding of risk information given during the counseling session.
• 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.
• online questionnaire

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
NSABP Foundation Inc	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM		Measured at start of study and at 3 to 6 months
Secondary	Factors hindering women from taking chemoprevention for breast cancer		Measured at start of study and at 3 to 6 months
Secondary	Reasons for the choice of raloxifene vs tamoxifen among menopausal women		Measured at start of study and at 3 to 6 months
Secondary	The implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women.		Measured at start of study and at 3 to 6 months
Secondary	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.		Measured at start of study and at 3 to 6 months
Secondary	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.		Measured at start of study and at 3 to 6 months