Depression and Body Image Distress Following Mastectomy With Reconstruction

NCT ID: NCT03428399

Last Updated: 2021-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-12

Study Completion Date

2021-05-03

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer BRCA1 Mutation BRCA2 Mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Psychosocial variables

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hilary Weingarden

Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilary Weingarden, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34449252 (View on PubMed)

Other Identifiers

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2017P000944

Identifier Type: -

Identifier Source: org_study_id

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