Psychological Effect of Expectations and Body Image on Outcomes of Breast Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Patient satisfaction with breast reconstruction measured with Breast Q reconstruction
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Demographic factors and medical factors according to medical charts(2 years)
- Satisfaction with preoperative information measured with Breast Q reconstruction(2 years)
- Depression and anxiety measured with Hospital Anxiety and Depression Scale (HADS)(2 years)
- Pain measured with a visual analogue scale(2 weeks)
- Sick leave according to authorities(1 year)
- Number of out-patient visits according to the medical charts(1 year)