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Effects of Expectations and Body Image in Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT04714463
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Implant-based breast reconstruction Procedure: Autologous breast reconstruction Procedure: Combined methods

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychological Effect of Expectations and Body Image on Outcomes of Breast Reconstruction
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Immediate breast reconstruction
Women undergoing immediate breast reconstruction due to breast cancer or a high risk for breast cancer
 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
Delayed breast reconstruction
Women undergoing delayed breast reconstruction due to breast cancer or a high risk for breast cancer
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Satisfaction with preoperative information measured with Breast Q reconstruction [ Time Frame: 2 years ]
    Measured with one of the sub scales of Breast Q reconstruction

  2. 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)

  3. Sick leave according to authorities [ Time Frame: 1 year ]
    Actual sick leave according to the Swedish authorities

  4. 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

  5. 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.

  6. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04714463


Contacts
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Contact: Emma Hansson, PhD +46313421000 emma.em.hansson@vgregion.se

Locations
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Sweden
Sahlgrenska university hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Linn Weick, MA    +46 31 342 10 00    linn.weick@vgregion.se   
Sponsors and Collaborators
Vastra Gotaland Region
Investigators
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Principal Investigator: Emma Hansson, PhD Göteborg University
More Information
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT04714463    
Other Study ID Numbers: 2020-06245
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: December 2020
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 Vastra Gotaland Region:
plastic surgery
breast reconstruction
complication
expectations
body image