Depression and Body Image Distress Following Mastectomy With Reconstruction

NCT03428399 | Completed

• 1 other identifier: 2017P000944
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; BRCA1 Mutation; BRCA2 Mutation

Keywords

breast reconstruction; mastectomy

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (1)

Breast reconstruction patients

Self-reported psychosocial variables and a clinical interview assessing mental health history will be administered prior to participants' scheduled mastectomy and breast reconstruction surgery (which is part of their routine medical care for cancer treatment or prevention). Follow up self-report measures will be collected after the surgery as well.

Other: Psychosocial variables

Interventions

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.

Breast reconstruction patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who are scheduled for mastectomy with immediate breast reconstruction at Massachusetts General Hospital as part of their routine medical care. The treatment plan for eligible participants may not include chemotherapy or radiation at the time of enrollment.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Weingarden H, Laky ZE, Ladis I, Austen WG Jr, Wilhelm S. Body Image After Mastectomy Scale: A New Measure of Body Image Behaviors and Beliefs in Women Following Mastectomy. J Womens Health (Larchmt). 2022 Jan;31(1):47-54. doi: 10.1089/jwh.2021.0131. Epub 2021 Aug 26.

  PMID: 34449252 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Psychology

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Hilary Weingarden, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 9, 2018
• Study Start: October 12, 2017
• Primary Completion: November 30, 2020
• Study Completion: May 3, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)