The present study involved a single-group intervention and a pre-post study. The research population comprised 64 patients with breast cancer who were seeking surgery, chemotherapy, and/or radiotherapy services. They were suffering from lymphedema caused by breast cancer and have been referred to the MACSA to receive palliative supportive services.
According to Montazeri et al.'s study, (12), which was conducted in the Iranian population using the EORTC QLQ-C30 questionnaire, with a three-month and one-year follow-up, the mean score was 59.2 (SD = 25.6), and the expected difference was considered to be 20 units. According to the findings of this study, the sample size was calculated to be 71 people. After accounting for a 10% attrition rate, the final sample size reached 78 people. Unfortunately, the occurrence of the COVID-19 pandemic in the midst of the research led to a significant decrease in the number of people seeking assistance at the MACSA Center. As a result, the initial projected time for diagnosis was extended from 12 months to approximately 16 months.
The study's inclusion criteria included individuals who had breast cancer and lymphedema resulting from the disease or its treatment, lacked supportive care, did not have other cancers or metastases, were older than 18 years old, were admitted to the MACSA rehabilitation unit and provided full consent to participate in the study and complete the consent form. In addition, to file a case in the MACSA, it was necessary to present a national identification card, the results of a pathology diagnosis, and proof of residence in one of the 22 districts of Tehran. The exclusion criteria included cancer recurrence, metastasis, and unwillingness to continue cooperation during the research. All patients were informed that withdrawing from the study would not disrupt the services provided to them.
Finally, 64 patients were included in the study. However, one person was excluded from the study due to the occurrence of metastasis during the research, and 6 patients were excluded due to concerns related to the coronavirus and their unwillingness to continue palliative care sessions or cooperate further. Finally, we reached a sample size of 57 patients.
In this study, we aimed to measure changes in QOL and its various aspects, including general health, physical function, individual and social function, and mental health after patients received palliative supportive services. Therefore, before the intervention and receiving palliative care, and one month after the end of receiving these services, patients were asked to complete two questionnaires from the European Organization for Research and Treatment of Cancer (EORTC): the standard Quality of Life Questionnaire (QLQ-C30) and the Quality of Life Questionnaire for Breast Cancer Patients (QLQ-BR23). The Persian version of these questionnaires was approved by the EORTC and validated by Montazeri et al. (13, 14)
Initially, a comprehensive medical history and disease history were obtained. Subsequently, the doctors treating lymphedema evaluated the diagnosis and classified the clinical stage of lymphedema according to the International Society of Lymphology (ISL) staging, which includes stages 0, I (mild), II (moderate), late II, and III (severe).(Table 1) (15, 16).In addition, to compare the physical changes, the circumference of the affected limb was measured at 6 specific locations, including the palm, wrist, 10 cm below the elbow, elbow, 10 cm above the elbow, and axilla (armpit). The QOL questionnaires were subsequently administered to the patients, who completed them in person.
Then, for all patients, based on the severity of primary lymphedema and at the discretion of the attending physician, between 7 and 14 sessions of lymphotherapy services were provided. These services included anticongestion treatment, a reduction in swelling through massage therapy, the use of an IPC device to drain lymphedema, bandage therapy, training in sports methods and bodily maneuvers at home to prevent recurrence or rapid progression of the complication. Additionally, at least 3 sessions of psychological care, including counseling and psychotherapy, were conducted. One month after receiving palliative supportive services, the patients were asked to complete the two questionnaires mentioned above. In the next step, the final scores for different QOL scales were obtained based on the scoring manual of the QLQ-C30 and QLQ-BR23 questionnaires (17). To investigate the impact of palliative supportive services on patients' QOL based on the questionnaires used, a paired t-test was conducted to determine whether there was a change in various areas of QOL after the intervention., the normality of all the data were checked before conducting the paired t-test. Descriptive data were summarized and presented based on variable type using common statistical methods. The analysis was conducted using SPSS software version 26.
The QLQ-C30 comprises 30 questions that assess QOL in 5 functional domains (physical, emotional, cognitive, social, and role functioning) and 9 symptom domains (fatigue, pain, nausea and vomiting, shortness of breath, diarrhea, constipation, sleep disturbance, loss of appetite, and financial impact of the disease), as well as a general QOL domain. The QLQ-BR23 comprises 23 questions and assesses 4 functional areas: mental image of the body, sexual performance, satisfaction with sexual performance, and attitude toward the future. It also evaluates 4 symptom areas: side effects caused by systemic treatments, complications in the patient's hand, complications in the affected breast, and discomfort from hair loss.