Approximately 2.1 million women were newly diagnosed with breast cancer in 2018 worldwide [1]. According to Global Cancer Observatory estimates, 684,996 breast cancer–related deaths occurred in 2020 [2]. In the Arab World, the incidence of breast cancer represents 14%-42% of all cancers in women [3]. This wide range is attributed to the capability of each country to detect, monitor, and treat patients with breast cancer [4]. For example, Kuwait, Bahrain, and Qatar can be classified as high-incidence areas with >40% of all female cancers [5]. Meanwhile, the United Arab Emirates, Saudi Arabia, and Oman are classified as low-incidence areas [6]. Lebanon, in particular, is a small Arabic middle-income country with a prominent breast cancer incidence [7]. A significant number of Lebanese women are diagnosed with an incidence rate that has been on the rise over the years, going from a reported 1451 cases in 2005 to 3219 cases in 2018 [8-10]. Approximately 920 (10%) breast cancer–related deaths occurred in 2018 [1].

Breast-conserving surgery (BCS) is one of the most recommended treatments for early-stage breast cancer [11,12]. According to El Saghir et al [4], BCS in Lebanon increased from 48% between 1997 and 2002 to 64% between 2002 and 2010, with a corresponding decrease in the total mastectomy rate from 51% to 36%.

Despite the increase in BCS, this treatment carries an array of side effects and uncomfortable physical symptoms as well as psychological disturbances, such as fear of recurrence, feelings of decreased femininity and attractiveness, and depression. The experience of breast cancer has a prevailing effect on female body image, which varies according to the clinical features and phases of the disease [13]. Unfortunate body image perceptions have the potential to negatively impact the physical and psychological functioning of patients with breast cancer and subsequently their health-related quality of life (HRQoL) [14].

Body image is defined as women’s perception and feelings about their body and their self-observation, self-esteem, social interaction, and belief [15]. Han et al [16] found that patients with breast cancer who had better conceptualization of their body image better managed with cancer. Furthermore, fatigue is one of the most common and disabling HRQoL symptoms of cancer among women successfully treated for breast cancer [17]. Fatigue is defined as a general feeling of debilitating tiredness or loss of energy. Fatigue can be associated with several symptoms, such as pain, sleep disturbance, and depression [18,19]. Thus, the impact of body image and fatigue on HRQoL can be extensive, reducing the patient’s engagement in work and personal and social activities [20]. With the intention of supporting patients who adapt to their illness and report positive mental health states, several studies have been performed to identify psychological resources that predict better outcomes. One of these resources is habitual or dispositional optimism, a personality trait that describes the degree to which a person generally expects positive outcomes [21,22]. Dispositional optimism is associated with HRQoL [23,24].

Robust scientific data on the HRQoL of patients with breast cancer postactive treatment in Lebanon, especially those who experienced BCS, are still scarce. Only 2 single-center studies with cross-sectional designs were conducted in Lebanon [25,26]. Data of the first study collected from 89 participants between 2009 and 2010 showed that younger, single, and better-educated participants who were diagnosed for <30 months, who had no metastasis, and who paid <US $450 per month on medical expenses had better HRQoL. The second study conducted among 150 female patients with breast cancer diagnosed between January 2009 and March 2014 showed that participants who were Iraqi, had stage 4 disease, had a monthly household income <US $1000, or had received chemotherapy exhibited significantly lower HRQoL. Impaired quality of life (QoL) was also reported in patients with worse psychological well-being [26]. The results of this study cannot be generalized because of the lack of a well-representative sample and the small sample size of patients [27-30]. In addition, this study did not compare the QoL of the same individuals at several time points but rather compared different participants with various times elapsed since diagnosis.

This study aims to describe changes in the HRQoL according to body image pre- and post-BCS and just before initiation of adjuvant therapy in newly diagnosed patients with breast cancer in Lebanon. The secondary objectives are (1) to assess changes in the HRQoL according to fatigue and optimism and pessimism between pre- and post-BCS and (2) to identify sociodemographic and clinical factors associated with changes in the HRQoL.

To meet the objectives of the study, a prospective study must be conducted.

After an explanation of the study, the principal researcher will answer the participants’ questions and present the consent form for signature. Patients will complete the questionnaires during 2 periods: the first assessment will be done on the admission day, and the second period is 1 day after the surgery (Figure 1). The estimated average time spent on assessment will be 30-45 minutes. The patients will complete the following questionnaires:

The study will be conducted in 2 hospitals located in Beirut, namely Rafik Hariri University Hospital and Sahel General Hospital. The duration of the study is estimated at approximately 34 months.

The proposal of the study was approved by the institutional review board of the Rafik Hariri University Hospital in Beirut (reference number: 18.007-Trans-CMO-[OM]) and the ethical committee of Sahel General Hospital. Informed consent was obtained from each participant. All necessary measures to safeguard participants’ anonymity and confidentiality of information were respected.

The primary outcome measure will be a change in the body image dimension of HRQoL. The secondary outcome measures will be changes in the HRQoL, first according to fatigue and second according to optimism and pessimism; the EORTC QLQ-C30 dimension (physical, emotional, social, role, cognitive, pain, nausea or vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss); and the EORTC QLQ-BR23 dimension (sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss), as summarized in Table 1.

Normally distributed continuous outcomes will be summarized as means and SDs. The rate of missing data at each HRQoL measurement time will be reported.

To compare the main scores of the EORTC QLQ-C30, QLQ-BR23, EQ-5D-5L, MFI-20, and LOT across pre- and postsurgery data, a paired t test will be used.

To compare possible differences between pre- and postsurgery outcomes, a one-way ANOVA will be used for quantitative variables.

The factors associated with the change in HRQoL according to body image before BCS will be identified using a multiple regression model. To determine the factors potentially predicting the change in HRQoL according to body image, Pearson correlation coefficients between all the numerical variables collected at inclusion and the body image scores at baseline and after surgery will be calculated.

Independent sample t tests and ANOVAs will be used to test differences in the mean scores of the main questionnaires used in this study and their subscales (EORTC QLQ-C30, QLQ-BR23, EQ-5D-5L, MFI-20, and LOT) and mean scores of demographic variables (age, residence, employment, and income) and clinical characteristics (comorbidities, BMI, and laboratory values). Pearson correlation between EORTC QLQ-C30 and EQ-5D-5L, MFI-20, and LOT scores and their subscales will be calculated to see which domain has the strongest relationship with QoL after surgery.

All analyses will be calculated with their 95% CIs; statistical significance will be set at P<.05. The collected data will be captured and analyzed using the SPSS software version 26 (IBM Corp).

The proposal of study is approved by the institutional review board of the Rafik Hariri University Hospital in Beirut (reference number: 18.007-Trans-CMO-[OM]) and the ethical committee of Sahel General Hospital.

Nowadays, Lebanese women in general reflect the importance of gender roles in the Lebanese culture and society; most women are still expected to be homemakers, taking care of their families’ needs, although many of them work outside the house and are breadwinners as much as their male partners [30]. However, most studies show that patients with breast cancer experience physical symptoms and psychosocial distress that adversely affect their HRQoL [44,45]. So far, according to limited data, there is a weakness in studies concerning the impact of HRQoL on Lebanese women with breast cancer [29]. This study will report an important gap in the literature by answering a crucial question regarding the patient-reported outcome of HRQoL after BCS. In this context, we designed a study to evaluate HRQoL changes between pre- and post-BCS and just before initiation of adjuvant therapy in newly diagnosed patients with invasive breast cancer, targeting the body image dimension as the primary outcome of interest.

This study is strengthened by its follow-up nature, allowing us to draw conclusions about causality. However, the questionnaires used were well-validated in Lebanese populations. However, some limitations must be acknowledged. As it is a sample of convenience and not population based, the generalizability of the results to the entire Lebanese population is not possible as data were collected from 2 hospitals only. However, our hospitals are a reference center in Beirut city for the treatment of breast cancer, and our population could be representative of this group of patients. On the other hand, considering the gap in the scientific literature on prospective studies focusing on HRQoL, body image, fatigue, and optimism and pessimism before and after BCS, this study is presented as the first prospective study on HRQoL of breast cancer in Lebanon.

Subgroup analysis will be performed to compare baseline characteristics and will be adjusted in the multivariable analysis considering those variables with significant differences.

In summary, the findings of this study will help decision makers, physicians, and social workers design a comprehensive program with multidisciplinary components for the management and care of patients with breast cancer in Lebanon.