CancerNCT07524179
Therapeutic Touch in Cancer Patients Receiving Palliative Care
A study testing Therapeutic Touch and Routine Palliative Care in people with Cancer and Palliative Care, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effect of therapeutic touch applied to advanced cancer patients receiving palliative care on sleep quality and fatigue severity. This is a randomized controlled experimental study using a pretest-posttest design. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer, Palliative Care, Therapeutic Touch
- What is being tested?
- Therapeutic Touch and Routine Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Aug 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Pathologically confirmed advanced-stage cancer (stage 3-4)
- Receiving palliative care treatment
- Richards-Campbell Sleep Questionnaire (RCSQ) score ≤50
- Fatigue Severity Scale (FSS) score ≥4
- Mini-Mental Test score ≥24
Who cannot join
- Known diagnosis of a major sleep disorder
- Presence of acute infection
- Widespread dermatological lesions compromising skin integrity (e.g., ulcer, eczema)
- Dementia, delirium, or severe cognitive impairment
- Hearing or vision loss that would hinder therapeutic communication
- Medical condition that would contraindicate the application as determined by the palliative care team
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum City Hospital Palliative Care Service
Erzurum, Merkez, 02040
About this study
Official title: The Effect of Therapeutic Touch on Sleep Quality and Fatigue Severity in Advanced Cancer Patients in the Palliative Care Setting: A Randomized Controlled Trial
This study aims to examine the effect of therapeutic touch applied to advanced cancer patients receiving palliative care on sleep quality and fatigue severity. This is a randomized controlled experimental study using a pretest-posttest design. The study includes advanced-stage cancer patients receiving support in a palliative care unit. Research data will be collected from patients between March and August 2024 using face-to-face interviews. The intervention group will receive therapeutic touch for 20 minutes per day for 5 consecutive days, while the control group will continue to receive routine palliative care. Data will be collected using a Personal Information Form, the Richards-Campbell Sleep Questionnaire (RCSQ), and the Fatigue Severity Scale (FSS).
Read the detailed description
Palliative care is a branch of healthcare that helps individuals who cannot achieve complete remission due to chronic diseases, mostly cancer, or who need care in the last period of life, to manage the multiple symptoms brought by the disease. The majority of cancer patients receiving palliative care treatment are in advanced cancer stages. The aim of treatment in cancer patients receiving palliative care is to improve quality of life and to manage pain, insomnia, fatigue, and other symptoms related to the disease. One of the most common problems experienced by these patients is insomnia and fatigue due to both treatment and the nature of the disease. These patients use many integrative methods as well as many medical treatments. One of these methods is therapeutic touch. The fact that this method has no known side effects makes it an attractive option for symptom management.
In the hospital setting, therapeutic touch can be applied in the patient's room and bed. After disinfecting the hands and bringing them to body temperature, the practitioner applies light, rhythmic touches to the patient's head, shoulders, arms, and feet. During this application, patients are asked to be in the most comfortable position. The therapeutic touch session for sleep, which is one of the variables of the study, should be performed close to the patient's bedtime (approximately 22:00). The application takes approximately 10-15 minutes.
Materials and Methods: The research is a randomized controlled experimental study with a pretest-posttest design. Randomization will be ensured by using a simple random number table.
Location of the Study: The study will consist of cancer patients receiving care and treatment services in the Palliative Care Service of Erzurum City Hospital, affiliated with the Ministry of Health of the Republic of Turkey.
Study Population and Sample Selection: Using G*Power 3.1.7 software, the sample size was calculated with a test power of 0.95. As a result of the analysis, it was determined that 30 patients should be included at the α=0.05 level, when the effect size was 0.10 and 95% power.
Implementation Protocol: After randomization, patients will be divided into two groups. Scales will be applied to the intervention group in the first interview and pretest data will be obtained. Therapeutic touch will be performed on the head, shoulders, hands, and feet for approximately 10-15 minutes, starting at 22:00, for 5 consecutive days.
Control Group: Patients in the control group will be interviewed at 22:00, and a sociodemographic questionnaire, the Richards-Campbell Sleep Questionnaire (RCSQ), and the Fatigue Severity Scale (FSS) will be administered. The data collection phase of the study will be completed by collecting posttest data from all groups after the last interview.
- Conditions
- Cancer, Palliative Care, Therapeutic Touch, Sleep, Fatigue Syndrome, Chronic
- Being tested
- Therapeutic Touch, Routine Palliative Care
- Keywords
- palliative care, cancer patient, sleep, fatigue, therapeutic touching
- Medical subject headings
- Neoplasms, Fatigue Syndrome, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchBehavioural
Therapeutic touch was applied to the head, shoulders, hands and feet for approximately 10-15 minutes per day for 5 consecutive days. The application was performed between 18:00-22:00 in the patient's room with privacy ensured. The protocol consisted of light, rhythmic touches based on the effleurage (stroking) technique.
Routine Palliative CareOther
Participants continued with routine palliative care protocols. No therapeutic touch or other specific touch-based intervention was applied.
| Study group | Role | What they receive |
|---|---|---|
| therapeutic touch intervention group | Experimental | Scales were applied to the intervention group in the first interview and pre-test data were obtained. In the next process, therapeutic touch was performed to the intervention group for approximately 10-15 minutes on the head, shoulders, hands and feet starting at 22:00 at night for 5 days on weekdays within the scope of the research. Receives: Behavioral: Therapeutic Touch |
| Control: Routine Palliative Care Group | Active comparator | Control group continued with routine palliative care protocols. No therapeutic touch or other specific touch-based intervention was applied. Scales were applied at the same time points as the intervention group. Receives: Other: Routine Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep quality measured by the Richards-Campbell Sleep Questionnaire (RCSQ). The scale consists of 5 items scored from 0 to 100. Higher scores indicate better sleep quality.
Measured: Baseline and immediately after 5-day intervention
Secondary outcomes (1)
Fatigue Severity
Fatigue severity measured by the Fatigue Severity Scale (FSS). The scale consists of 9 items scored from 1 to 7. The total score is calculated by summing all item scores and dividing by 9. Higher scores indicate more severe fatigue.
Measured: Baseline and immediately after 5-day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Mar 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- This research was planned as a randomized controlled experimental study.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ercan Bakır, Erzurum Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524179
- Sponsor's protocol ID
- 27.03.2024-23396
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 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 due to confidentiality and privacy concerns. The data contain sensitive patient information and institutional review board approval does not include data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Touch on Sleep Quality and Fatigue Severity in Advanced Cancer Patients in the Palliative Care Setting: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07524179
- Acronym / sponsor ID
- 27.03.2024-23396
- Conditions
- Cancer, Palliative Care, Therapeutic Touch, Sleep, Fatigue Syndrome, Chronic
- Keywords
- palliative care, cancer patient, sleep, fatigue, therapeutic touching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 13 Apr 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.
This study aims to examine the effect of therapeutic touch applied to advanced cancer patients receiving palliative care on sleep quality and fatigue severity. This is a randomized controlled experimental study using a pretest-posttest design. The study includes advanced-stage cancer patients receiving support in a palliative care unit. Research data will be collected from patients between March and August 2024 using face-to-face interviews. The intervention group will receive therapeutic touch for 20 minutes per day for 5 consecutive days, while the control group will continue to receive routine palliative care. Data will be collected using a Personal Information Form, the Richards-Campbell Sleep Questionnaire (RCSQ), and the Fatigue Severity Scale (FSS).
Detailed description
Palliative care is a branch of healthcare that helps individuals who cannot achieve complete remission due to chronic diseases, mostly cancer, or who need care in the last period of life, to manage the multiple symptoms brought by the disease. The majority of cancer patients receiving palliative care treatment are in advanced cancer stages. The aim of treatment in cancer patients receiving palliative care is to improve quality of life and to manage pain, insomnia, fatigue, and other symptoms related to the disease. One of the most common problems experienced by these patients is insomnia and fatigue due to both treatment and the nature of the disease. These patients use many integrative methods as well as many medical treatments. One of these methods is therapeutic touch. The fact that this method has no known side effects makes it an attractive option for symptom management.
In the hospital setting, therapeutic touch can be applied in the patient's room and bed. After disinfecting the hands and bringing them to body temperature, the practitioner applies light, rhythmic touches to the patient's head, shoulders, arms, and feet. During this application, patients are asked to be in the most comfortable position. The therapeutic touch session for sleep, which is one of the variables of the study, should be performed close to the patient's bedtime (approximately 22:00). The application takes approximately 10-15 minutes.
Materials and Methods: The research is a randomized controlled experimental study with a pretest-posttest design. Randomization will be ensured by using a simple random number table.
Location of the Study: The study will consist of cancer patients receiving care and treatment services in the Palliative Care Service of Erzurum City Hospital, affiliated with the Ministry of Health of the Republic of Turkey.
Study Population and Sample Selection: Using G*Power 3.1.7 software, the sample size was calculated with a test power of 0.95. As a result of the analysis, it was determined that 30 patients should be included at the α=0.05 level, when the effect size was 0.10 and 95% power.
Implementation Protocol: After randomization, patients will be divided into two groups. Scales will be applied to the intervention group in the first interview and pretest data will be obtained. Therapeutic touch will be performed on the head, shoulders, hands, and feet for approximately 10-15 minutes, starting at 22:00, for 5 consecutive days.
Control Group: Patients in the control group will be interviewed at 22:00, and a sociodemographic questionnaire, the Richards-Campbell Sleep Questionnaire (RCSQ), and the Fatigue Severity Scale (FSS) will be administered. The data collection phase of the study will be completed by collecting posttest data from all groups after the last interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research was planned as a randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| therapeutic touch intervention group | Experimental | Behavioral: Therapeutic TouchScales were applied to the intervention group in the first interview and pre-test data were obtained. In the next process, therapeutic touch was performed to the intervention group for approximately 10-15 minutes on the head, shoulders, hands and feet starting at 22:00 at night for 5 days on weekdays within the scope of the research. |
| Control: Routine Palliative Care Group | Active comparator | Other: Routine Palliative CareControl group continued with routine palliative care protocols. No therapeutic touch or other specific touch-based intervention was applied. Scales were applied at the same time points as the intervention group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Pathologically confirmed advanced-stage cancer (stage 3-4)
- Receiving palliative care treatment
- Richards-Campbell Sleep Questionnaire (RCSQ) score ≤50
- Fatigue Severity Scale (FSS) score ≥4
Key exclusion criteria (6 listed)
- Known diagnosis of a major sleep disorder
- Presence of acute infection
- Widespread dermatological lesions compromising skin integrity (e.g., ulcer, eczema)
- Dementia, delirium, or severe cognitive impairment
- Hearing or vision loss that would hinder therapeutic communication
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 |
|---|---|---|
| Therapeutic TouchTherapeutic touch was applied to the head, shoulders, hands and feet for approximately 10-15 minutes per day for 5 consecutive days. The application was performed between 18:00-22:00 in the patient's room with privacy ensured. The protocol consisted of light, rhythmic touches based on the effleurage (stroking) technique. | Behavioural | therapeutic touch intervention group |
| Routine Palliative CareParticipants continued with routine palliative care protocols. No therapeutic touch or other specific touch-based intervention was applied. | Other | Control: Routine Palliative Care Group |
Primary outcome
Sleep Quality
Time frame: Baseline and immediately after 5-day intervention
Sleep quality measured by the Richards-Campbell Sleep Questionnaire (RCSQ). The scale consists of 5 items scored from 0 to 100. Higher scores indicate better sleep quality.
1 secondary outcome
Fatigue Severity
Time frame: Baseline and immediately after 5-day intervention
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 13 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality and privacy concerns. The data contain sensitive patient information and institutional review board approval does not include data sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Touch and Routine Palliative Care in people with Cancer and Palliative Care, run by Erzurum Technical University 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 6 inclusion and 6 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 13 Apr 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?
Sleep Quality (time frame: Baseline and immediately after 5-day intervention). 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 13 Apr 2026.