Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04714463

Effects of Expectations and Body Image in Breast Reconstruction

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implant-based breast reconstruction

Procedure

All types of implant based breast reconstructions

Autologous breast reconstruction

Procedure

All types of autologous breast reconstructions

Combined methods

Procedure

All types of breast reconstructions combining autologous and implant based techniques

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Hansson, PhD

CONTACT

[email protected]

+46313421000

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2021
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.