The Effect of Integratıve Therapıes on Fatıgue Management and Qualıty of Lıfe in Cancer Patıents Undergoıng Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- FACT-G Quality of Life Scale
研究概览
简要总结
Aim: This study was conducted as a randomized controlled experimental study to determine the effect of integrative therapies on fatigue management and qualiy of life in cancer patients receiving immunotherapy.
Materials and Methods: In the study 60 patients, 30 in the intervention group and 30 in the control group were included in the sample. The intervention group was given Pranayama breathing exercise for 20 minutes before immunotherapy treatment and listened to music during immunotherapy. Study data were collected using the "Patient Information Form ", "FACT-G Quality of Life Scale " and "Hirai Cancer Fatigue Scale ". Appropriate statistical methods were used to analyze the data.
详细描述
This study was planned to determine the effect of integrative therapies on fatigue management and quality of life in cancer patients undergoing immunotherapy. It was designed as a randomised controlled experimental type study determined by simple random sampling method.
Hypotheses of the Study H1: There is a significant difference in terms of fatigue level between the intervention group and the control group in which music recital and yoga practice were performed in cancer patients receiving immunotherapy.
H2: There is a significant difference between the intervention group and the control group in terms of quality of life level in cancer patients receiving immunotherapy.
Variables of the Study Independent Variables: Age, occupation, marital status, education level, chronic diseases, medications, smoking, alcohol consumption status.
Dependent Variables: Fatigue, quality of life. Controlled Variables: Yoga practices, music recital
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The intervention group was given Pranayama breathing exercise for 20 minutes before immunotherapy treatment and music was played during immunotherapy. The study data were collected using the "Patient Information Form", "FACT-G Quality of Life Scale" and "Hirai Cancer Fatigue Scale". Appropriate statistical methods were used to analyse the data.
Outcome assessments were evaluated by a researcher who was unaware of the group distribution.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving immunotherapy treatment for cancer diagnosis,
- •Reads and writes,
- •Over 18 years old,
- •Able to communicate, no language problems,
- •Those who volunteered to participate in the study and whose consent was obtained,
- •Not diagnosed with a mental or psychiatric illness,
- •Patients without hearing impairment were included in the study.
排除标准
- •Unable to adapt to planned interventions,
- •Hearing impaired,
- •Not volunteering to participate in the study,
- •Patients with mental disability or perception problems were not included in the study.
- •Patients who wanted to leave the study voluntarily were excluded from the study.
- •In our study, there were no participants who wanted to leave the study voluntarily.
研究组 & 干预措施
Pranayama Group
Collection of Experimental Group Data: Patient Information Form (Appendix-1), FACT-G Quality of Life Scale (Appendix-2) and Hirai Cancer Fatigue Scale (Appendix-3) were filled in the first interview. Pranayama breathing exercise was performed by the practitioner for 20 minutes before the immunotherapy application. For the application, a quiet room with limited entrance and exit, which was reserved for injection applications within the unit, was preferred. After the application, the patient was taken to the treatment department for immunotherapy treatment and was allowed to listen to music with headphones during immunotherapy treatment. The patient was contacted by phone to listen to music and do pranayama exercise at least 3 days a week for 8 weeks following the treatment.
干预措施: Pranayama Group (Other)
Control Group
Patient Information Form, FACT-G Quality of Life Scale and Hirai Cancer Fatigue Scale were filled in the first interview. Patients in the control group received standard immunotherapy treatment without any treatment before immunotherapy. In the fourth and eighth week following the treatment, the FACT-G Quality of Life Scale and Hirai Cancer Fatigue Scale were filled out and the patients were followed up for eight weeks.
结局指标
主要结局
FACT-G Quality of Life Scale
时间窗: 8 weeks
It is one of the scales belonging to the FACIT (Functional Assessment of Chronic Illness Therapy) measurement system, which includes questionnaires aiming to measure health-related quality of life in chronic diseases. In the 4th version of the FACT-G questionnaire consisting of 27 items, the questions are divided into four main groups. These are; Physical well-being (Physical Status 7 questions), Social life and family well-being (Social Life and Family Status 7 questions), Functional well-being (Activity Status 7 questions), Emotional well-being (Emotional Status 6 questions). Scoring is done for each item of the scale by giving 0 points for None, 1 point for Very Little, 2 points for Some, 3 points for Quite, and 4 points for Very Much. Reverse scoring was used for questions with negative connotations.
次要结局
- Hirai Cancer Fatigue Scale(8 weeks)
研究者
Gamze Temiz
Asistant Professor
Saglik Bilimleri Universitesi