Oncology
Conditions
Keywords
Fatigue, Immunotherapy, Integrative Therapy, Quality of Life
Brief summary
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.
Detailed description
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 Place and Time of the Research The study was conducted in the medical oncology outpatient clinic of the internal medicine department of a state university hospital in Istanbul. Inclusion Criteria * 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. Exclusion Criteria * 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. ENSURING RANDOMISATION IN THE STUDY Before the data collection phase, simple random sampling method was used to ensure that the participants to be included in the study had equal rights. With the computer-based randomisation method, the participants were numbered according to the order of arrival and divided into group 1 intervention group and group 2 control group. Collection of Pranayama Group Data Patient Information Form, FACT-G Quality of Life Scale and Hirai Cancer Fatigue Scale 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. The application was repeated before each immunotherapy and the application was continued for a total of 8 weeks. The FACT-G Quality of Life Scale and Hirai Cancer Fatigue Scale ed by face-to-face interviews with the patient in the fourth and eighth weeks. Collection of Control Group Data 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 were not treated before immunotherapy, standard immunotherapy treatment was applied. The FACT-G Quality of Life Scale and Hirai Cancer Fatigue Scale were filled in the fourth and eighth week following the treatment and the patients were followed up for eight weeks
Interventions
OTHERPranayama Group
Patient Information Form, FACT-G Quality of Life Scale and Hirai Cancer Fatigue Scale were filled in the first interview. Patients in the intervention group were given Pranayama breathing exercise by the practitioner for 20 minutes before immunotherapy and then were allowed to listen to music with headphones during immunotherapy treatment. The patient was contacted by telephone for the patient to listen to music and do pranayama exercise at least 3 days a week for 8 weeks following the treatment. The application was repeated before each immunotherapy and the application was continued for a total of 8 weeks. The FACT-G Quality of Life Scale and Hirai Cancer Fatigue Scale were completed by face-to-face interviews with the patient in the fourth and eighth weeks.
Sponsors
Saglik Bilimleri Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
The study was a randomised controlled trial with 60 patients, 30 in the intervention group and 30 in the control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FACT-G Quality of Life Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hirai Cancer Fatigue Scale | 8 weeks | The scale developed by Kazue Hirai et al. in 2015, originally named 'Hirai Cancer Fatigue Scale', consists of 15 items. The scale measures fatigue in cancer patients and is 5-point Likert type. Each item of the scale is evaluated as 1 "not at all", 2 "very little", 3 "a little", 4 "a lot", 5 "very much". There are 3 sub-dimensions: physical - mental sub-dimension, activity-related sensitivity, cognitive sensitivity. Items 1-6 in the scale include physical-mental sub-dimension, items 7-12 include activity-related sensitivity sub-dimension and items 12-15 include cognitive sensitivity sub-dimension. The scale has no cut-off point. The minimum value of the scale is 15 and the maximum value is 75. High scores on the scale indicate increased fatigue and low scores indicate decreased fatigue (77). In 2021, Mencel conducted validity and reliability with 1006 cancer patients and found it to be highly valid and reliable. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORGamze Temiz, Dr
Istanbul University - Cerrahpasa
Outcome results
None listed