Clinical trial NCT04714463: Effects of Expectations and Body Image in Breast Reconstruction
Official title: Psychological Effect of Expectations and Body Image on Outcomes of Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: plastic surgery
breast reconstruction
complication
expectations
body image
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2021-01-19
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Patient satisfaction with breast reconstruction measured with Breast Q reconstruction
timeFrame: 2 years
measure: Patient expectations measured with Breast Q expectations
timeFrame: 2 years
measure: Body image measured with Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS)
timeFrame: 2 years
measure: Body image investment measured with Appearance schemas inventory-revised (ASI-R)
timeFrame: 2 years
Secondary outcomes:
measure: Satisfaction with preoperative information measured with Breast Q reconstruction
timeFrame: 2 years
measure: Pain measured with a visual analogue scale
timeFrame: 2 weeks
measure: Sick leave according to authorities
timeFrame: 1 year
measure: Number of out-patient visits according to the medical charts
timeFrame: 1 year
measure: Depression and anxiety measured with Hospital Anxiety and Depression Scale (HADS)
timeFrame: 2 years
measure: Demographic factors and medical factors according to medical charts
timeFrame: 2 years
Other outcomes:
measure: Translation and validation of Breast-Q expectations
timeFrame: 4 months
measure: Translation and validation of Appearance schemas inventory-revised (ASI-R)
timeFrame: 4 months
measure: Translation and validation of Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS)
timeFrame: 4 months
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
Study officials:
affiliation: Göteborg University
name: Emma Hansson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weick L, Grimby-Ekman A, Lunde C, Hansson E. Validation and reliability testing of the BREAST-Q expectations questionnaire in Swedish. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):315-323. doi: 10.1080/2000656X.2022.2070180. Epub 2022 May 9.