Effects of Expectations and Body Image in Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Psychological Effect of Expectations and Body Image on Outcomes of Breast Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714463
• Other study ID #: 2020-06245
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Vastra Gotaland Region
• Contact: Emma Hansson, PhD
• Phone: +46313421000
• Email: emma.em.hansson[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Implant-based breast reconstruction
All types of implant based breast reconstructions
• Autologous breast reconstruction
All types of autologous breast reconstructions
• Combined methods
All types of breast reconstructions combining autologous and implant based techniques

Locations

Country	Name	City	State
Sweden	Sahlgrenska university hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Translation and validation of Breast-Q expectations	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.	4 months
Other	Translation and validation of Appearance schemas inventory-revised (ASI-R)	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.	4 months
Other	Translation and validation of Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS)	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.	4 months
Primary	Patient satisfaction with breast reconstruction measured with Breast Q reconstruction	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 years
Primary	Patient expectations measured with Breast Q expectations	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.	2 years
Primary	Body image measured with Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS)	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.	2 years
Primary	Body image investment measured with Appearance schemas inventory-revised (ASI-R)	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.	2 years
Secondary	Satisfaction with preoperative information measured with Breast Q reconstruction	Measured with one of the sub scales of Breast Q reconstruction	2 years
Secondary	Pain measured with a visual analogue scale	Measured with a post-operative pain dairy with VAS scales (o means no pain and 10 means the worst possible pain imaginable)	2 weeks
Secondary	Sick leave according to authorities	Actual sick leave according to the Swedish authorities	1 year
Secondary	Number of out-patient visits according to the medical charts	Actual number of out-patient visits, according to the medical chart	1 year
Secondary	Depression and anxiety measured with Hospital Anxiety and Depression Scale (HADS)	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.	2 years
Secondary	Demographic factors and medical factors according to medical charts	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.	2 years