Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)

An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

The goal of this research study is to learn more about how different treatment decisions may influence the quality of life in women with breast cancer. Researchers want to use what is learned from this study to help future patients with breast cancer to be more informed when making treatment decisions. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: Questionnaires
Type of treatment: Lifestyle or therapy programme
How many people: 345 participants
Where: 2 sitesUnited States
Study dates: 24 Feb 2014to 30 Apr 2028
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Breast cancer patients seen at University of Texas MD Anderson Cancer Center and at Kelsey Seybold Clinic.

Who may be able to join

Newly diagnosed ductal carcinoma in situ (DCIS) or Stage I-III sporadic unilateral invasive breast cancer
Age 18 or older
Able to speak, read, and write English.
Spouse/Partner: Married or living with patient for a year or more
Spouse/Partner: Age 18 or older
Spouse/Partner: Able to speak, read, and write English

Who cannot join

Patients with previous breast cancer
Prior history of prophylactic mastectomy
Known to have a germline gene mutation that predisposes them to an increased risk of breast cancer (e.g., BRCA1, BRCA2), and/or if they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Kelsey-Seybold
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Treatment Decisions and Breast Cancer: Psychosocial Outcomes

Read the detailed description

With your verbal permission, you may have been asked to complete a questionnaire about your surgical treatment preferences for breast cancer as part of initial screening for this study. This takes about 5 minutes to complete.

If you agree to participate in this study, during the same visit you will complete a questionnaire about your background, such as your education level, marital status, and family history of cancer. This should take about 3 minutes to complete.

You will also be asked to complete a questionnaire about your surgery decisions and your feelings about those decisions at the following times: around the time you enroll in study before your surgery, and again about 1, 6, and 12 months after the surgery is completed. This questionnaire should take about 30-40 minutes to complete each time. You may complete this questionnaire at the clinic or you may complete it at home. If you chose to complete the questionnaire at home, you will be given a postage-paid envelope to mail it back to the study staff.

Length of Study:

After you complete all of the questionnaires, your participation in this study will be over.

This is an investigational study.

A total of up to 345 participants will be enrolled in this study. Up to 245 will take part at MD Anderson and up to 100 will take part at Kelsey-Seybold.

Conditions: Breast Cancer
Being tested: Questionnaires
Keywords: Breast Cancer, Contralateral Prophylactic Mastectomy, Questionnaires, Surveys, Psychosocial
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuestionnairesBehavioural
Also called Surveys
Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, 12, and 18 months after the surgery is completed.

Study groups in NCT02263014
Study group	Role	What they receive
Contralateral Prophylactic Mastectomy (CPM) Group		Group of women who decide to have contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery is completed. Receives: Behavioral: Questionnaires
No Contralateral Prophylactic Mastectomy (CPM) Group		Group of women who decide not to have contralateral prophylactic mastectomy (CPM) performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery is completed. Receives: Behavioral: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score
Cancer-specific distress was measured with the Impact of Events Scale (IES) to assess 2 common categories of responses to stressful events: intrusion and avoidance. The IES scale consists of 15 items. For the intrusion category (7 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range is 0 to 35). For the avoidance category (8 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range 0 to 40). The total cancer-specific distress score is the sum of the total intrusion score and the total avoidance score (complete range is 0 to 75). The total distress score was averaged for surveys completed at each time point. Higher mean scores indicate greater cancer-specific distress.
Measured: Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision
The Satisfaction with Decision Scale (SWD) scale measures women's satisfaction with their surgery decision using the SWD six-item survey with a five-point scale where 1 is "strongly disagree" and 5 is "strongly agree" and the sum is the total score (complete range 6 to 30). The total satisfaction with decision score was averaged for surveys completed at each time point. Higher mean scores indicate greater satisfaction with the treatment decision.
Measured: One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 201430 Apr 2028

First posted13 Oct 2014 (estimated)
Study start24 Feb 2014
Primary completion1 Oct 2016
Study completion30 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 345 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02263014
Sponsor's protocol ID: 2013-0752
Other IDs: NCI-2020-07371
Status last verified: May 2026
First submitted: 8 Oct 2014
Last updated: 8 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Parker PA, Peterson SK, Shen Y, Bedrosian I, Black DM, Thompson AM, Nelson JC, DeSnyder SM, Cook RL, Hunt KK, Volk RJ, Cantor SB, Dong W, Brewster AM. Prospective Study of Psychosocial Outcomes of Having Contralateral Prophylactic Mastectomy Among Women With Nonhereditary Breast Cancer. J Clin Oncol. 2018 Sep 1;36(25):2630-2638. doi: 10.1200/JCO.2018.78.6442. Epub 2018 Jul 25.
PubMed 30044695

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Decisions and Breast Cancer: Psychosocial Outcomes
ClinicalTrials.gov ID: NCT02263014
Acronym / sponsor ID: 2013-0752
Conditions: Breast Cancer
Keywords: Breast Cancer, Contralateral Prophylactic Mastectomy, Questionnaires, Surveys, Psychosocial
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 345 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 24 Feb 2014 (actual)
Primary completion: 1 Oct 2016 (actual)
Study completion: 30 Apr 2028 (estimated)
First posted: 13 Oct 2014 (estimated)
Results: Posted 5 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Length of Study:

After you complete all of the questionnaires, your participation in this study will be over.

This is an investigational study.

A total of up to 345 participants will be enrolled in this study. Up to 245 will take part at MD Anderson and up to 100 will take part at Kelsey-Seybold.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Contralateral Prophylactic Mastectomy (CPM) Group	–	Behavioral: QuestionnairesGroup of women who decide to have contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery is completed.
No Contralateral Prophylactic Mastectomy (CPM) Group	–	Behavioral: QuestionnairesGroup of women who decide not to have contralateral prophylactic mastectomy (CPM) performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery is completed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Breast cancer patients seen at University of Texas MD Anderson Cancer Center and at Kelsey Seybold Clinic.

Key inclusion criteria (6 listed)

Newly diagnosed ductal carcinoma in situ (DCIS) or Stage I-III sporadic unilateral invasive breast cancer
Age 18 or older
Able to speak, read, and write English.
Spouse/Partner: Married or living with patient for a year or more
Spouse/Partner: Age 18 or older

Key exclusion criteria (3 listed)

Patients with previous breast cancer
Prior history of prophylactic mastectomy
Known to have a germline gene mutation that predisposes them to an increased risk of breast cancer (e.g., BRCA1, BRCA2), and/or if they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QuestionnairesAlso: SurveysScreening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, 12, and 18 months after the surgery is completed.	Behavioural	Contralateral Prophylactic Mastectomy (CPM) Group, No Contralateral Prophylactic Mastectomy (CPM) Group

Primary outcome

Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score
Time frame: Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
Cancer-specific distress was measured with the Impact of Events Scale (IES) to assess 2 common categories of responses to stressful events: intrusion and avoidance. The IES scale consists of 15 items. For the intrusion category (7 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range is 0 to 35). For the avoidance category (8 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range 0 to 40). The total cancer-specific distress score is the sum of the total intrusion score and the total avoidance score (complete range is 0 to 75). The total distress score was averaged for surveys completed at each time point. Higher mean scores indicate greater cancer-specific distress.
Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision
Time frame: One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
The Satisfaction with Decision Scale (SWD) scale measures women's satisfaction with their surgery decision using the SWD six-item survey with a five-point scale where 1 is "strongly disagree" and 5 is "strongly agree" and the sum is the total score (complete range 6 to 30). The total satisfaction with decision score was averaged for surveys completed at each time point. Higher mean scores indicate greater satisfaction with the treatment decision.

Results and safety

Results posted to the registry on 5 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CPM Group	44	44
No CPM Group	208	208

Primary outcome: Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score

Time frame: Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.. Mean (Standard Error). Unit: units on a scale

Measure	CPM Group n = 42	No CPM Group n = 208
Pre-Surgery	29.98 (16.77)	24.62 (16.52)
1 Month Post-surgery	21.84 (14.58)	19.84 (14.8)
6 Months Post-surgery	23.43 (14.69)	18.56 (16.11)
12 Months Post-surgery	25.3 (17.26)	17.01 (14.79)

Population analysed: Two participants of the CPM Group (N=44) who had CPM after the date of their primary surgery were excluded from the longitudinal study analysis. \*The overall number of patients analyzed may differ from the total number analyzed at each time point since not all surveys were returned at each time point.

Primary outcome: Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision

Time frame: One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.. Mean (Standard Error). Unit: units on a scale

Measure	CPM Group n = 42	No CPM Group n = 208
1 Month assessment	4.23 (1.08)	4.27 (0.81)
6 month assessment	4.18 (1.06)	4.33 (0.76)
12 month assessment	4.35 (0.86)	4.34 (0.75)

Adverse events

Time frame: Adverse event data collected up to 12 months following surgery for breast cancer.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CPM Group	0 of 44 (0%)	0 of 44 (0%)	0 of 44
No CPM Group	0 of 208 (0%)	0 of 208 (0%)	0 of 208

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30044695Parker PA, Peterson SK, Shen Y, Bedrosian I, Black DM, Thompson AM, Nelson JC, DeSnyder SM, Cook RL, Hunt KK, Volk RJ, Cantor SB, Dong W, Brewster AM. Prospective Study of Psychosocial Outcomes of Having Contralateral Prophylactic Mastectomy Among Women With Nonhereditary Breast Cancer. J Clin Oncol. 2018 Sep 1;36(25):2630-2638. doi: 10.1200/JCO.2018.78.6442. Epub 2018 Jul 25.
University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abenaa M. Brewster, MD, MHS, BS principal investigator

M.D. Anderson Cancer Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score (time frame: Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02263014, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.