CancerNCT07619209
The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises Applied to Palliative Care Cancer Patients on Dyspnea, Fatigue, and Self-Care Behaviors
A study testing Progressive Muscle Relaxation and Deep Breathing Exercises in people with Cancer and Fatigue, run by Ankara University at 4 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effects of Progressive Muscle Relaxation (PMR) exercises and deep breathing exercises on dyspnea, fatigue, and self-care behaviors among cancer patients receiving palliative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Fatigue, Palliative Care
- What is being tested?
- Progressive Muscle Relaxation and Deep Breathing Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2026to Dec 2026
- Phase
- Interventional
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
- Being 18 years of age or older
- Being literate (able to read and write)
- Having no significant hearing or visual impairment that prevents communication or cooperation
- Receiving treatment in the palliative care unit
- Having a confirmed medical diagnosis of cancer
- Having a Glasgow Coma Scale (GCS) score of 10 or higher
Show all 11Show fewer
- Being able to communicate via telephone and SMS for post-discharge follow-up
- Having a Common Terminology Criteria for Adverse Events (CTCAE) Dyspnea Classification of Grade 3 or below
- Having an ECOG Performance Status Scale score of 3 or below
- Having a Hemoglobin (Hb) value of 8 gm/dL or higher
- Volunteering to participate in the study and providing informed consent
Who cannot join
- Currently practicing or having recently practiced Progressive Muscle Relaxation (PMR) or deep breathing exercises actively
- Having a primary respiratory system disease diagnosis (such as COPD, asthma, or pneumonia)
- Having a medical diagnosis of dementia, agitation, or delirium
- Receiving Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) support
- Being on active antipsychotic or sedative medical treatment
- Having a Common Terminology Criteria for Adverse Events (CTCAE) Dyspnea Classification of Grade 4 or higher
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Ankara Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital, Palliative Care Unit
Ankara, YENIMAHALLE, 06120
ASLIHAN POYRAZ, aslihan.kulcu@gmail.com
- Recruiting
Ankara Ataturk Sanatorium Training and Research Hospital,Palliative Care Unit
Ankara, 06100
ASLIHAN POYRAZ, aslihan.kulcu@gmail.com
- Recruiting
Ankara Sincan Training and Research Hospital, Palliative Care Unit
Ankara, 06100
ASLIHAN POYRAZ, aslihan.kulcu@gmail.com
- Recruiting
Gulhane Training and Research Hospital, Palliative Care Unit
Ankara, 06100
ASLIHAN POYRAZ, aslihan.kulcu@gmail.com
About this study
The purpose of this study is to evaluate the effects of Progressive Muscle Relaxation (PMR) exercises and deep breathing exercises on dyspnea, fatigue, and self-care behaviors among cancer patients receiving palliative care. Advanced-stage cancer patients frequently experience debilitating symptoms such as shortness of breath (dyspnea) and severe fatigue, which significantly impair their functional capacity and daily self-care activities. Participants in this study will be assigned to either a progressive muscle relaxation intervention group or a structured deep breathing exercise group. The study aims to determine whether these non-pharmacological relaxation techniques can effectively reduce the severity of dyspnea and fatigue, thereby improving the patients' overall self-care behaviors and physical comfort in a palliative care setting.
Read the detailed description
Palliative care is defined by the World Health Organization (WHO) as "an approach that improves the quality of life of patients (adults and children) and their families who are facing problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial, and spiritual". Emphasizing the needs of patients and their families rather than the treatment of the disease itself, the primary goals of palliative care include reducing the disease burden and alleviating pain and other distressing symptoms. Palliative care is implemented for individuals with life-threatening chronic conditions such as cancer, cardiovascular diseases, HIV/AIDS, Alzheimer's and other dementias, liver cirrhosis, chronic obstructive pulmonary diseases (COPD), diabetes, kidney failure, multiple sclerosis, Parkinson's disease, rheumatoid arthritis, and drug-resistant . According to the European Association for Palliative Care (EAPC), approximately 4.4 million people (including 14,000 children) in the WHO European Region require palliative care each year. Patients diagnosed with cancer constitute the vast majority of those in need of palliative care, accounting for 34.01%. Indeed, the foundations of palliative care in our country began with interventions aimed at relieving pain and alleviating other symptoms of cancer patients by algology specialists and oncologists. Along with increased life expectancy and improving living conditions, an increase in cancer diseases is observed. According to global cancer statistics, with approximately 20 million new cancer cases and 9.7 million cancer deaths worldwide in 2022, it has become a major health problem both globally and for our country. Cancer patients require palliative care especially during the final stages of their lives/terminal period.
In palliative care, individuals experience numerous disease-related symptoms such as pain, fatigue, pruritus, cough, constipation, nausea, vomiting, dysphagia, dehydration, anorexia, delirium, and dyspnea. Advanced-stage cancer patients constitute a large proportion of patients receiving palliative care, and dyspnea is observed in approximately 10-70% of cancer patients. It is known that the prevalence of dyspnea rises up to 90% in patients with lung cancer. Dyspnea and shortness of breath are defined by ESMO as "a qualitatively distinct and subjective experience of breathing discomfort that varies in intensity". The experienced dyspnea causes anxiety, fear, fatigue, and a decrease in the quality of life in individuals. Fatigue is another frequently observed symptom in palliative care conditions. Fatigue is defined by patients using various concepts such as "weakness, exhaustion, tiredness, insomnia, and lack of strength." Cancer-related fatigue is a distressing symptom commonly seen in cancer patients that adversely affects activities of daily living and health-related quality of life. Fatigue occurs at a rate of 60-90% in cancer patients receiving palliative care.
In a study conducted by Uysal et al. (2015) on patients receiving palliative care, they determined that the most common symptoms observed were anxiety (92%), pain (90%), nausea (66%), constipation (61%), and shortness of breath (59%) (Uysal et al., 2015). In another study evaluating 142 cancer patients with palliative care needs, the presence of fatigue (87.3%), dyspnea (76.1%), and sleep problems (67.6%) were found to be the most prevalent, respectively.
Dyspnea burden and fatigue negatively affect the patient's self-care, their capacity to perform daily activities, functional capacity, and performance status. Self-care, as defined by Orem, is the form of care that an individual performs independently by displaying controlled, purposeful, and effective behaviors along with maintaining their health and well-being. Dyspnea and fatigue can affect self-care behaviors such as bathing, dressing, toileting, mobility, elimination, and nutrition by causing functional limitations in patients . The purpose of palliative care is to eliminate or alleviate these symptoms that may be observed in patients as early as possible. Thus, by performing a more effective symptom management, physical and psychological relief of patients will be achieved, thereby enhancing their self-care behaviors and quality of life .
Many pharmacological and non-pharmacological treatment methods are applied for the symptoms observed in palliative care patients. One of the non-pharmacological methods applied is breathing exercises. Breathing exercises for dyspnea management include pursed-lip breathing and diaphragmatic breathing. Pursed-lip breathing involves patients inhaling deeply through the nose and exhaling this breath over 4-6 seconds by pursing their lips. Pursed-lip breathing leads to an increase in tidal volume and arterial oxygen levels, a decrease in respiratory rate, and a decrease in arterial carbon dioxide levels. Diaphragmatic breathing involves the patient expanding their abdomen while inhaling, flattening the diaphragm muscle, and then exhaling by pursing their lips. During exhalation, the diaphragm is pushed upward by the abdominal muscles, and the utilization of diaphragm muscles is increased, thereby enhancing the ventilation level of the lungs. Studies have shown that performing pursed-lip and diaphragmatic breathing either alone or in combination are effective methods in relieving dyspnea-related distress in patients. Another non-pharmacological application for symptoms is relaxation exercises. Progressive Muscle Relaxation (PMR) covers the conscious contraction and relaxation of major muscle groups throughout the entire body. Each muscle or muscle group is tensed for 5-7 seconds and then relaxed for 20-30 seconds. One of the most important steps in the application of PMR is the correct breathing exercise. Relaxation exercises are applied simultaneously with deep breathing exercises, requiring the patient to breathe correctly, deeply, and effectively during the tensing-relaxing phase of the muscle groups. With the patient breathing effectively, correctly, and deeply throughout the exercise, the oxygen needed by using the whole of the lungs is taken into the body, and the relaxation of the patient is achieved through the relaxation of the muscles. Studies have revealed that relaxation techniques reduce heart rate, respiratory rate, and dyspnea, thereby being effective on fatigue by increasing functional performance. In studies conducted on cancer patients, it has also been determined that progressive muscle relaxation exercises are effective on weakness, loss of energy, fatigue, and dyspnea. Patients and their relatives in the palliative care process face many physical, psychosocial, and spiritual problems and difficulties. During this period, multiple symptoms observed in cancer patients negatively affect patients' physical and social functions, treatment course, and survival times. Therefore, preventing the occurrence of symptoms or controlling existing symptoms in palliative care patients is of great importance for patients and their relatives.
As a result of the literature review, no studies targeting dyspnea and fatigue symptoms observed in cancer patients receiving palliative care were found. The aim of our study is to examine the effects of progressive muscle relaxation and deep breathing exercises to be applied to cancer patients receiving palliative care on dyspnea, fatigue, and self-care behaviors.
This randomized controlled study aims to evaluate the effects of Progressive Muscle Relaxation (PMR) and Deep Breathing Exercises on dyspnea, fatigue, and self-care behaviors among cancer patients receiving palliative care. Patients meeting the inclusion criteria will be informed about the study's purpose, content, and method. Standard palliative care will be continued for all patients across all groups.
Study Arms and Interventions:
Following the randomization process, patients will be assigned to one of the following three groups for a duration of 6 weeks:
Intervention Group 1 (PMR Group): In the initial interview, patients will receive visual training regarding Progressive Muscle Relaxation (PMR) exercises. They will be provided with and instructed on how to use an MP3 player to practice these exercises at home. These patients will be asked to perform PMR exercises once a day for 6 weeks.
Intervention Group 2 (Deep Breathing Group): Patients in this group will receive detailed training on deep breathing exercises. They will be requested to perform these breathing exercises twice a day for 6 weeks.
Control Group: Patients assigned to this group will receive standard routine clinical care and follow-up without any additional experimental relaxation or breathing intervention.
For hospitalized patients in both intervention groups, the exercises will be directly administered and supervised by the researcher. Following patient discharge, the continuity and monitoring of the exercise protocols will be managed via phone-call follow-ups.
Data Collection and Timeline:
Data collection and instrument administration will be performed uniformly for all three groups at three specific timelines: Baseline (Pre-intervention), Week 3, and Week 6. The following measurement tools and scales will be utilized:
Patient Demographics and Characteristics Form
Common Terminology Criteria for Adverse Events (CTCAE) Dyspnea Classification
ECOG Performance Status Scale
Cancer Dyspnea Scale (CDS)
Hirai Cancer Fatigue Scale
KATZ Index of Independence in Activities of Daily Living (ADL)
Glasgow Coma Scale (GCS)
- Conditions
- Cancer, Fatigue, Palliative Care, Progressive Muscle Relaxation, Patient
- Being tested
- Progressive Muscle Relaxation, Deep Breathing Exercises
- Keywords
- Palliative Care, Cancer Patients, Progressive Muscle Relaxation, Deep Breathing Exercises, Dyspnea Management, Cancer-Related Fatigue, Self-Care Behaviors, Randomized Controlled Trial
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationBehavioural
A structured relaxation training based on tension and release of major muscle groups. In the initial session, patients will receive visual and practical education on how to perform PMR. They will be provided with an MP3 player containing guided audio instructions to facilitate independent practice. Patients will be instructed to perform the PMR program once daily for 6 weeks. For hospitalized patients, the sessions will be guided directly by the researcher; discharged patients will be followed up via phone.
Deep Breathing ExercisesBehavioural
A structured respiratory intervention consisting of controlled breathing techniques, specifically diaphragmatic (abdominal) breathing and pursed-lip breathing, aimed at managing dyspnea. Detailed practical training on these techniques will be provided to the patients in the first interview. Patients will be requested to perform these breathing exercises twice daily for 6 weeks. Hospitalized patients will perform them under the researcher's supervision, and discharged patients will be monitored via weekly phone calls.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1: Progressive Muscle Relaxation | Experimental | Patients in this group will receive standard clinical care and a structured Progressive Muscle Relaxation (PMR) program. In the initial session, patients will be provided with visual education on PMR exercises and trained on how to use an MP3 player containing guided exercise tracks for home practice. They will be requested to perform the PMR exercises once daily for a total duration of 6 weeks. For hospitalized patients, the exercises will be directly administered and supervised by the researcher. Follow-up after discharge will be maintained via weekly phone calls. Receives: Behavioral: Progressive Muscle Relaxation |
| Intervention Group 2: Deep Breathing Exercises | Experimental | Patients in this group will receive standard clinical care and a structured deep breathing exercise program, including pursed-lip breathing and diaphragmatic breathing techniques. In the initial session, detailed practical training on these respiratory techniques will be provided by the researcher. Patients will be requested to perform these deep breathing exercises twice daily for a total duration of 6 weeks. For hospitalized patients, the exercises will be directly supervised by the researcher. Follow-up after discharge will be managed via weekly phone calls. Receives: Behavioral: Deep Breathing Exercises |
| Control Group: Standard Care | No intervention | Patients assigned to this group will receive standard routine clinical care, symptom management, and regular clinical follow-up provided by the palliative care unit. No additional experimental relaxation or respiratory exercise protocols will be administered to this group during the 6-week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Dyspnea Scale (CDS)
The Cancer Dyspnea Scale (CDS) will be used to evaluate the multidimensional breathlessness/dyspnea experienced by cancer patients. It consists of 12 items across 3 subscales: sense of effort, sense of anxiety, and sense of discomfort. Each item is rated on a 5-point Likert scale (from 1 to 5). Total scores range from 12 to 60, with higher scores indicating a higher intensity and severity of cancer-related dyspnea.
Measured: Baseline (Pre-intervention), Week 3, and Week 6
Hirai Cancer Fatigue Scale
Used to assess the level of cancer-related fatigue in patients. Higher scores on this clinical scale reflect a higher severity and burden of fatigue, impacting the patient's daily functional capacity.
Measured: Baseline (Pre-intervention), Week3, Week 6
Katz Index of Independence in Activities of Daily Living (ADL)
Used to measure the patient's functional independence in performing basic daily activities (bathing, dressing, toileting, transferring, continence, and feeding). Total scores range from 0 to 6, where higher scores indicate a higher level of independence.
Measured: Baseline (Pre-intervention), Week 3, and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- A randomized, parallel-group trial design with three arms will be used. Participants will be randomly assigned to one of three groups in a 1:1:1 allocation ratio: Intervention Group 1 (Progressive Muscle Relaxation program), Intervention Group 2 (Deep Breathing Exercises program), or the Control Group (Standard clinical care and follow-up). All groups will be monitored simultaneously over a 6-week intervention period, and data collection will be completed parallelly across all cohorts at baseline, Week 3, and Week 6.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslıhan Poyraz, RN, PhD(c), Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619209
- Sponsor's protocol ID
- 2025-20/214
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to maintain patient confidentiality and comply with institutional ethical committee guidelines, which restrict data usage strictly to the primary research team for this doctoral thesis
Publications
Patel MS. Strategies for the Optimal Management of Dyspnea in Cancer Patients With Advanced Illness. Oncology (Williston Park). 2018 Dec 17;32(12):583-5, 590.
PubMed 30632127Ozhanli Y, Akyuz N. The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety Levels of Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):238-246. doi: 10.1016/j.jopan.2021.08.008. Epub 2021 Dec 10.
PubMed 34903440Nese A, Samancioglu Baglama S. The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises on Dyspnea and Fatigue Symptoms of COPD Patients: A Randomized Controlled Study. Holist Nurs Pract. 2022 Jul-Aug 01;36(4):E18-E26. doi: 10.1097/HNP.0000000000000531.
PubMed 35708562Hui D, Bohlke K, Bao T, Campbell TC, Coyne PJ, Currow DC, Gupta A, Leiser AL, Mori M, Nava S, Reinke LF, Roeland EJ, Seigel C, Walsh D, Campbell ML. Management of Dyspnea in Advanced Cancer: ASCO Guideline. J Clin Oncol. 2021 Apr 20;39(12):1389-1411. doi: 10.1200/JCO.20.03465. Epub 2021 Feb 22.
PubMed 33617290Hui D, Maddocks M, Johnson MJ, Ekstrom M, Simon ST, Ogliari AC, Booth S, Ripamonti C; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Management of breathlessness in patients with cancer: ESMO Clinical Practice Guidelinesdagger. ESMO Open. 2020 Dec;5(6):e001038. doi: 10.1136/esmoopen-2020-001038. No abstract available.
PubMed 33303485Yilmaz CK, Kapucu S. The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in Individuals With COPD. Holist Nurs Pract. 2017 Nov/Dec;31(6):369-377. doi: 10.1097/HNP.0000000000000234.
PubMed 29028775Kirca K, Kutluturkan S. The effect of progressive relaxation exercises on treatment-related symptoms and self-efficacy in patients with lung cancer receiving chemotherapy. Complement Ther Clin Pract. 2021 Nov;45:101488. doi: 10.1016/j.ctcp.2021.101488. Epub 2021 Oct 2.
PubMed 34619419Demir Ö, Arslantaş H (2016). Müzik eşliğinde uygulanan progresif gevşeme egzersizinin anjiyografi ve perkütan transluminal koroner anjiyoplasti olacak hastaların yaşam bulgularına etkisi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi.; 19:1 84.
Hassanpour-Dehkordi A, Jalali A. Effect of Progressive Muscle Relaxation on the Fatigue and Quality of Life Among Iranian Aging Persons. Acta Med Iran. 2016 Jul;54(7):430-6.
PubMed 27424013Corcoran E. Palliative care and dyspnea. Clin J Oncol Nurs. 2013 Aug 1;17(4):438-40. doi: 10.1188/13.CJON.438-440.
PubMed 23899984Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751