Fatıgue Management and Qualıty of Lıfe

NCT07754565 | Completed

• 1 other identifier: HSBE-HEM-ON-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology

Keywords

Fatigue; Immunotherapy; Integrative Therapy; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Hirai Cancer Fatigue Scale

  8 weeks

Study Arms (2)

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.

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.

Interventions

Pranayama Group OTHER

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.

Pranayama Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Health Science University

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gamze Temiz, Dr

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Model Details: The study was a randomised controlled trial with 60 patients, 30 in the intervention group and 30 in the control group.

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: August 10, 2026
• Study Start: November 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: February 28, 2024
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)