Depression and Body Image Distress Following Mastectomy With Reconstruction

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.

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Key information

Conditions

Breast Cancer BRCA1 Mutation BRCA2 Mutation Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Psychosocial variables

Other

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.

Primary outcomes

Body Image Scale (BIS)

Time frame: 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)

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2021
First posted: Feb 9, 2018
Registry last updated: Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed