Breast cancer is defined as the most common type of cancer that causes death among women (Siegel et al. 2019). It constitutes 24% of cancers and 15% of cancer-related deaths in women (T.R. Ministry of Health 2020). According to statistics made towards the end of 2020, there are 7.8 million women in the world who were diagnosed with breast cancer in the last 5 years and are alive. It is estimated that one in every 8 women will develop breast cancer in developed countries (WHO 2021). The Ministry of Health reported the frequency of breast cancer in our country as 45.6/100,000 in women in 2018. The incidence of breast cancer is reported to be higher, especially in the 45-54 age range (TC Ministry of Health 2020). Chemotherapy is one of the most frequently preferred treatment methods in the treatment of breast cancer and can cause serious side effects such as pain, nausea and vomiting, loss of appetite, shortness of breath, mouth sores, fatigue, insomnia, anxiety and depression, and may lead to a deterioration in the quality of life of patients (Waks and Winer 2019, Samami et al. 2021, Sajadian et al. 2017, McFarland et al. 2018, Hamer et al. 2017). In the international and national literature, no study has been found comparing the effects of laughter and mindfulness therapy on the anxiety, depression, quality of life and spiritual well-being experienced by breast cancer patients. In this study, it is planned to investigate the effects of laughter and mindfulness therapy applications on the anxiety, depression, quality of life and spiritual well-being levels of women with breast cancer receiving chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
105
They will gather in five-person chemotherapy rooms, and laughter therapy will be applied to the women in the application group while they are receiving chemotherapy. Sessions will last approximately 40-60 minutes.The application will last for a total of 8 weeks, twice a week. The 9th and 16th sessions will be held face to face and the scales will be filled in face to face meetings in these weeks (at the end of the 4th week and the 8th week). Since patients receive chemotherapy treatment once a month, face-to-face sessions are planned to be administered while the patient is receiving treatment. (Those whose treatment timing frequency is not appropriate will be excluded). * Other sessions will be held online via smartphone applications. Online sessions will be determined according to the mutual decision of the participants, at a time convenient for the participants. * In the 12th week, all groups will have the scales filled in again.
Mindfulnes therapy will be applied to the women in the application group while they are receiving chemotherapy, in five-person chemotherapy rooms. Sessions will last approximately 40-60 minutes.The application will last for a total of 8 weeks, twice a week. The 9th and 16th sessions will be held face to face and the scales will be filled in face to face meetings in these weeks (at the end of the 4th week and the 8th week). Since patients receive chemotherapy treatment once a month, face-to-face sessions are planned to be administered while the patient is receiving treatment. (Those whose treatment timing frequency is not appropriate will be excluded). * Other sessions will be held online via smartphone applications. Online sessions will be determined according to the mutual decision of the participants, at a time convenient for the participants. * In the 12th week, all groups will have the scales filled in again.
Hatay Iskenderun State Hospital
İskenderun, Hatay, Turkey (Türkiye)
RECRUITINGHospital anxiety and depression scale outcomes
According to the scoring, 0-7 is considered as not sick, 8-10 is borderline sick, and 11 and above is considered seriously ill.
Time frame: The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith (1983). In the scale consisting of 14 items, 7 of the items measure anxiety symptoms and the other 7 measure depression symptoms.
European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-30) outcomes
Higher scores on the functional scale indicate higher/healthier functions, and higher scores on the general health status/quality of life indicate higher quality of life. However, high scores on the symptom scale indicate a high rate of symptomatology/problems (Fayers et al. 2001).
Time frame: It is an assessment tool used in cancer patients and whose reliability, applicability and validity have been tested in large patient populations in 12 different countries (Björdal et al. 1999).
Spiritual well-being scale (Facıt-Sp-12) outcomes
Meaning sub-dimension (Items 2,3,5,8) has a total score of 0-16 points, Peace sub-dimension (Items 1,4,6,7) has a total score of 0-16 points, Belief sub-dimension (Items 9,10,11) ,12) total score ranges from 0-16 points, and the total score of the scale is 0-48 points. A higher scale score indicates better spiritual well-being.
Time frame: The scale was developed by Peterman and his colleagues to determine the spiritual well-being of individuals with cancer and other chronic diseases (Peterman et al. 2002).
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