Depression and Body Image Distress Following Mastectomy With Reconstruction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03428399|
Recruitment Status : Active, not recruiting
First Posted : February 9, 2018
Last Update Posted : February 23, 2021
|Condition or disease||Intervention/treatment|
|Breast Cancer BRCA1 Mutation BRCA2 Mutation||Other: Psychosocial variables|
|Study Type :||Observational|
|Actual Enrollment :||51 participants|
|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|
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.
- 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).
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Hilary Weingarden, PhD||Massachusetts General Hospital|