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Depression and Body Image Distress Following Mastectomy With Reconstruction

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ClinicalTrials.gov Identifier: NCT03428399
Recruitment Status : Active, not recruiting
First Posted : February 9, 2018
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Hilary Weingarden, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment
Breast Cancer BRCA1 Mutation BRCA2 Mutation Other: Psychosocial variables

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk and Protective Factors for Depression and Body Image Distress Following Mastectomy With Breast Reconstruction
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : November 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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 Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428399


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Hilary Weingarden, PhD Massachusetts General Hospital
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Responsible Party: Hilary Weingarden, Psychologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03428399    
Other Study ID Numbers: 2017P000944
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hilary Weingarden, Massachusetts General Hospital:
breast reconstruction
mastectomy
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms