NCT07619209

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
5mo left

Started Jan 2026

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 24, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

Palliative CareCancer PatientsProgressive Muscle RelaxationDeep Breathing ExercisesDyspnea ManagementCancer-Related FatigueSelf-Care BehaviorsRandomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline (Pre-intervention), Week 3, and Week 6

Study Arms (3)

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.

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.

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.

Interventions

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.

Intervention Group 1: Progressive Muscle Relaxation

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.

Intervention Group 2: Deep Breathing Exercises

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ankara Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital, Palliative Care Unit

Ankara, YENIMAHALLE, 06120, Turkey (Türkiye)

RECRUITING

Ankara Ataturk Sanatorium Training and Research Hospital,Palliative Care Unit

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Ankara Sincan Training and Research Hospital, Palliative Care Unit

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Gulhane Training and Research Hospital, Palliative Care Unit

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (11)

  • 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.

  • Ozhanli 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.

  • Nese 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.

  • Hui 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.

  • Hui 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.

  • Yilmaz 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.

  • Kirca 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.

  • Demir 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.

    RESULT
  • 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.

  • Corcoran E. Palliative care and dyspnea. Clin J Oncol Nurs. 2013 Aug 1;17(4):438-40. doi: 10.1188/13.CJON.438-440.

  • Bray 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.

Related Links

MeSH Terms

Conditions

NeoplasmsFatigue

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

ASLIHAN POYRAZ, RN, PhD Candidate

CONTACT

Sevinç KUTLUTÜRKAN, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
To prevent reporting and analysis bias, a strict blinding protocol will be implemented for data management and statistical analysis. An independent researcher, who is completely blinded to the allocation of the study groups, will code the groups and transfer the collected data into the SPSS software. Furthermore, the statistical analysis will be performed by an independent biostatistician who remains fully blinded to which code represents the intervention or control groups throughout the entire analysis process.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 1, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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

Locations