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Depression and Body Image Distress Following Mastectomy With Reconstruction

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ClinicalTrials.gov Identifier: NCT03428399
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
Hilary Weingarden, Massachusetts General Hospital

Tracking Information
First Submitted Date February 5, 2018
First Posted Date February 9, 2018
Last Update Posted Date August 6, 2021
Actual Study Start Date October 12, 2017
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2018)
  • 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Depression and Body Image Distress Following Mastectomy With Reconstruction
Official Title Risk and Protective Factors for Depression and Body Image Distress Following Mastectomy With Breast Reconstruction
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Breast Cancer
  • BRCA1 Mutation
  • BRCA2 Mutation
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.
Study Groups/Cohorts 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.
Intervention: Other: Psychosocial variables
Publications * 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). 2021 Aug 26. doi: 10.1089/jwh.2021.0131. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 1, 2020)
51
Original Estimated Enrollment
 (submitted: February 8, 2018)
49
Actual Study Completion Date May 3, 2021
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03428399
Other Study ID Numbers 2017P000944
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hilary Weingarden, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Hilary Weingarden, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2021