Depression and Body Image Distress Following Mastectomy With Reconstruction

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428399
• Other study ID #: 2017P000944
• Status: Completed
• Start date: October 12, 2017
• Est. completion date: May 3, 2021

Study information

• Verified date: August 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 3, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation
• Breast Cancer
• Depression

Intervention

Other:
• Psychosocial 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Image Scale (BIS)	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).	2-3 months post-surgery (i.e., Time 2)
Primary	Beck Depression Inventory-II (BDI-II)	Assesses severity of depressive symptoms with a summed total score, which ranges from 0 (no depressive symptoms) to 63 (severe depressive symptoms).	2-3 months post-surgery (i.e., Time 2)