The Effect of Laughter and Mindfulness Therapy Applications on Women With Breast Cancer Receiving Chemotherapy: Randomized Controlled Study

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Laughter and Mindfulness Based Stress Reduction Applications on Anxiety, Depression, Quality of Life and Spiritual Well-Being Levels of Women With Breast Cancer Receiving Chemotherapy: Randomized Controlled Study

Conditions
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Breast Cancer, Laughter Therapy, Mindfulness Therapy, Life Quality, Anxiety and Depression, Spiritual Well-being

Intervention / Treatment
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* Other: the laughter therapy group
* Other: the mindfulness therapy group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are 18 years of age or older, do not have communication problems, have and can use a smartphone, do not have internet problems to participate in group sessions, volunteer to participate in the study, receive chemotherapy at least once a month and will continue to receive chemotherapy during the study. Women with stage 1 and stage 2 breast cancer, women with primary and secondary education, women within the first year of treatment in terms of the number of cycles, women with a score of 8 or more on the Hospital anxiety and depression scale (0-7 points are normal, 8- A score of 10 is borderline, 11 and above indicates abnormality). Exclusion Criteria: Women who did not meet the inclusion criteria, refused to participate in the study, and participated in less than 80% of the research practices (It is recommended to participate in at least 6 out of 8 sessions in the literature (Liu et al. 2022).), Women who use mindfulness therapy, laughter therapy or any complementary or integrative medicine in their daily lives outside the research, women who have a diagnosed psychological disease, metastasis or recurrence, and whose chemotherapy treatment was terminated before the study was completed, Women with stage 3 and stage 4 breast cancer, women who have been receiving chemotherapy for more than 1 year, women whose scores are 8 or below on the Hospital anxiety and depression scale (0-7 points indicate normal, 8-10 points indicate borderline, 11 and above indicate abnormality ).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the laughter therapy group<br>Women diagnosed with breast cancer who meet the inclusion criteria and are receiving chemotherapy will receive laughter therapy twice a week for an average of 40-60 minutes for 8 weeks. | Other: the laughter therapy group<br>* 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.<br>|
| Experimental: the mindfulness therapy group<br>Women diagnosed with breast cancer who meet the inclusion criteria and are receiving chemotherapy will receive an average of 40-60 minutes of mindfulnes therapy twice a week for 8 weeks. | Other: the mindfulness therapy group<br>* 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.<br>|
| No Intervention: the control group<br>Women diagnosed with breast cancer who meet the inclusion criteria and are receiving chemotherapy will receive standard hospital care only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital anxiety and depression scale outcomes | According to the scoring, 0-1 is considered as not sick, 2 is borderline sick, and 2-3 is considered seriously ill. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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). |