OncologyFatıgue ManageNCT07754565
Fatıgue Management and Qualıty of Lıfe
A study testing Pranayama Group in people with Oncology, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Pranayama Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Integratıve Therapıes on Fatıgue Management and Qualıty of Lıfe in Cancer Patıents Undergoıng Immunotherapy
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.
Read the 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
- Conditions
- Oncology
- Being tested
- Pranayama Group
- Keywords
- Fatigue, Immunotherapy, Integrative Therapy, Quality of Life
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pranayama GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pranayama Group | Other | 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. Receives: Other: Pranayama Group |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-G Quality of Life Scale
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.
Measured: 8 weeks
Secondary outcomes (1)
Hirai Cancer Fatigue Scale
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Nov 2022
- Primary completion1 Nov 2022
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was a randomised controlled trial with 60 patients, 30 in the intervention group and 30 in the control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Temiz, Saglik Bilimleri Universitesi
- Investigators
- Gamze Temiz, Dr, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754565
- Sponsor's protocol ID
- HSBE-HEM-ON-01
- Acronym
- Fatıgue Manage
- Status last verified
- Aug 2026
- First submitted
- 6 Jul 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Integratıve Therapıes on Fatıgue Management and Qualıty of Lıfe in Cancer Patıents Undergoıng Immunotherapy
- ClinicalTrials.gov ID
- NCT07754565
- Acronym / sponsor ID
- Fatıgue Manage / HSBE-HEM-ON-01
- Conditions
- Oncology
- Keywords
- Fatigue, Immunotherapy, Integrative Therapy, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was a randomised controlled trial with 60 patients, 30 in the intervention group and 30 in the control group.
| Arm | Type | Receives |
|---|---|---|
| Pranayama Group | Other | Other: Pranayama GroupCollection 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pranayama GroupPatient 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. | Other | Pranayama Group |
Primary outcome
FACT-G Quality of Life Scale
Time frame: 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.
1 secondary outcome
Hirai Cancer Fatigue Scale
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Temiz, Dr study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama Group in people with Oncology, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT-G Quality of Life Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.