Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Expectations and Body Image in Breast 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04714463
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Tracking Information
First Submitted Date January 12, 2021
First Posted Date January 19, 2021
Last Update Posted Date January 19, 2021
Estimated Study Start Date February 1, 2021
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2021)
  • Patient satisfaction with breast reconstruction measured with Breast Q reconstruction [ Time Frame: 2 years ]
    Breast Q reconstruction includes two domains and six different modules: health-related quality of life (HR-QOL; including physical, psychosocial, and sexual well-being) and patient satisfaction (including satisfaction with breasts, outcome, and care). Each scale produces an independent score from 0-100. A higher score means greater satisfaction or better QOL.
  • Patient expectations measured with Breast Q expectations [ Time Frame: 2 years ]
    Breast Q expectations.The scale consists of five modules: expectations for support from medical staff , expectations for pain, expectations for coping, expectations for breast appearance when clothed and expectations for breast sensation. The score for each independent scale range from 0-100. A higher score means greater expectations.
  • Body image measured with Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS) [ Time Frame: 2 years ]
    MBSRQ-AS - Multidimensional body-self relations questionnaire- appearance scales.It is a 34-item self-report questionnaire designed to measure appearance related components of body-image. In consists of five subscales: appearance evaluation, appearance orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. It is a 5-point Likert-scale ranging from 1 to 5.
  • Body image investment measured with Appearance schemas inventory-revised (ASI-R) [ Time Frame: 2 years ]
    ASI-R - Appearance schemas inventory-revised: is a 20-item self-report questionnaire designed to measure body-image investment. It consists of two subscales, self-evaluative salience (SES) and motivational salience (MS). It is a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). Twelve items relate to SES and eight items relate to MS. The total score is the mean of the 20 items, and the score of the subscales is the mean of the items relating to each subscale. A high score indicates greater body-image investment.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 14, 2021)
  • Satisfaction with preoperative information measured with Breast Q reconstruction [ Time Frame: 2 years ]
    Measured with one of the sub scales of Breast Q reconstruction
  • Pain measured with a visual analogue scale [ Time Frame: 2 weeks ]
    Measured with a post-operative pain dairy with VAS scales (o means no pain and 10 means the worst possible pain imaginable)
  • Sick leave according to authorities [ Time Frame: 1 year ]
    Actual sick leave according to the Swedish authorities
  • Number of out-patient visits according to the medical charts [ Time Frame: 1 year ]
    Actual number of out-patient visits, according to the medical chart
  • Depression and anxiety measured with Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 2 years ]
    HADS - Hospital Anxiety and Depression Scale: is a 14-item self-report questionnaire that is designed to measure anxiety and depression. It has two domains, where seven items relate to anxiety and seven relate to depression. It is a 4-point Likert-scale ranging from 0-3. Each domain has a maximum score of 21. For both domains, scores of less than 7 indicate non-cases, whereas scores of 8-10 indicate mild anxiety or depression, 11-14 moderate and 15-21 severe.
  • Demographic factors and medical factors according to medical charts [ Time Frame: 2 years ]
    Demographic factors that might affect expectations and satisfaction, such as age, comorbidity, and previous cosmetic breast surgery, and medical factors such as timing of reconstructions, reason for mastectomy, type of cancer and cancer treatment received.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 14, 2021)
  • Translation and validation of Breast-Q expectations [ Time Frame: 4 months ]
    Translation into Swedish according to MAPI-guidelines. Validation of psychometric properties in a Swedish population.The scale consists of five modules: expectations for support from medical staff , expectations for pain, expectations for coping, expectations for breast appearance when clothed and expectations for breast sensation. The score for each independent scale range from 0-100. A higher score means greater expectations.
  • Translation and validation of Appearance schemas inventory-revised (ASI-R) [ Time Frame: 4 months ]
    Translation into Swedish according to MAPI-guidelines. Validation of psychometric properties in a Swedish population. ASI-Ris a 20-item self-report questionnaire designed to measure body-image investment. It consists of two subscales, self-evaluative salience (SES) and motivational salience (MS). It is a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). Twelve items relate to SES and eight items relate to MS. The total score is the mean of the 20 items, and the score of the subscales is the mean of the items relating to each subscale. A high score indicates greater body-image investment.
  • Translation and validation of Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS) [ Time Frame: 4 months ]
    Translation into Swedish according to MAPI-guidelines. Validation of psychometric properties in a Swedish population.Multidimensional body-self relations questionnaire- appearance scales.It is a 34-item self-report questionnaire designed to measure appearance related components of body-image. In consists of five subscales: appearance evaluation, appearance orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. It is a 5-point Likert-scale ranging from 1 to 5.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Effects of Expectations and Body Image in Breast Reconstruction
Official Title Psychological Effect of Expectations and Body Image on Outcomes of Breast Reconstruction
Brief Summary A breast reconstruction after mastectomy, either due to breast cancer or a high lifetime risk for cancer, is performed to increase the patient's quality of life. However, there are studies that show that some women regret their decision to have breast reconstruction. There are also studies demonstrating similarities in the general patterns of psychosocial adjustment and quality of life among women with breast cancer who have undergone breast-conserving surgery, mastectomy alone, and mastectomy combined with breast reconstruction. Hence, it is unclear which women actually benefit from a breast reconstruction. The concept of quality of life is connected to patient satisfaction and body image/investment. Therefore, the aim of this project is to examine the effects of patient expectations and body image on the patient reported outcomes of breast reconstruction, to improve preoperative information and postoperative care for women considering a breast reconstruction.
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 Biological women with breast cancer or high risk for breast cancer who want immediate or delayed post-mastectomy breast reconstruction.
Condition Breast Cancer
Intervention
  • Procedure: Implant-based breast reconstruction
    All types of implant based breast reconstructions
  • Procedure: Autologous breast reconstruction
    All types of autologous breast reconstructions
  • Procedure: Combined methods
    All types of breast reconstructions combining autologous and implant based techniques
Study Groups/Cohorts
  • Immediate breast reconstruction
    Women undergoing immediate breast reconstruction due to breast cancer or a high risk for breast cancer
    Interventions:
    • Procedure: Implant-based breast reconstruction
    • Procedure: Autologous breast reconstruction
    • Procedure: Combined methods
  • Delayed breast reconstruction
    Women undergoing delayed breast reconstruction due to breast cancer or a high risk for breast cancer
    Interventions:
    • Procedure: Implant-based breast reconstruction
    • Procedure: Autologous breast reconstruction
    • Procedure: Combined methods
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 14, 2021)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Biological women with breast cancer or high risk for breast cancer who want post-mastectomy breast reconstruction
  • Age > 18 years

Exclusion Criteria:

  • Inability to give informed consent
  • Inability to understand Swedish
  • Relaps of cancer
  • Palliative treatment
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Biological women with breast cancer or high risk for breast cancer who want post-mastectomy breast reconstruction
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Emma Hansson, PhD +46313421000 emma.em.hansson@vgregion.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04714463
Other Study ID Numbers 2020-06245
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 Vastra Gotaland Region
Study Sponsor Vastra Gotaland Region
Collaborators Not Provided
Investigators
Principal Investigator: Emma Hansson, PhD Göteborg University
PRS Account Vastra Gotaland Region
Verification Date December 2020