Skip to content

Depression and Body Image Distress Following Mastectomy With Reconstruction

Risk and Protective Factors for Depression and Body Image Distress Following Mastectomy With Breast Reconstruction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03428399
Enrollment
51
Registered
2018-02-09
Start date
2017-10-12
Completion date
2021-05-03
Last updated
2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRCA1 Mutation, BRCA2 Mutation, Breast Cancer

Keywords

breast reconstruction, mastectomy

Brief summary

Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. However, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. The present study aims to address this critical gap. In women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.

Interventions

OTHERPsychosocial variables

The investigators will assess mental health history and self-reported psychosocial variables as hypothesized risk and protective factors for body image and depression severity in breast reconstruction patients, before and after their mastectomy and breast reconstruction surgery. Mastectomy and breast reconstruction will be received in the context of routine medical care. Thus, this is not a psychological intervention, but rather observational measures assessed pre- and post routine care for breast reconstruction patients.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Female adults (age 18+) who are scheduled for mastectomy with immediate breast reconstruction at the Massachusetts General Hospital (MGH) Plastic and Reconstructive Surgery Program 2. English language proficiency 3. Ability to provide informed consent.

Exclusion criteria

1. Current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder 2. Current active suicidal ideation 3. Current treatment plan includes radiation and/or ongoing chemotherapy 4. Does not have access to Internet at home, required to complete study questionnaires

Design outcomes

Primary

MeasureTime frameDescription
Body Image Scale (BIS)2-3 months post-surgery (i.e., Time 2)Assesses severity of body image distress related to breast cancer treatment with a summed total score, which ranges from 0 (no body image distress) to 30 (substantial body image distress).
Beck Depression Inventory-II (BDI-II)2-3 months post-surgery (i.e., Time 2)Assesses severity of depressive symptoms with a summed total score, which ranges from 0 (no depressive symptoms) to 63 (severe depressive symptoms).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026