NCT07524179

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

March 31, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

palliative carecancer patientsleepfatiguetherapeutic touching

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and immediately after 5-day intervention

Secondary Outcomes (1)

  • Fatigue Severity

    Baseline and immediately after 5-day intervention

Study Arms (2)

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.

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.

Other: Routine Palliative Care

Interventions

Participants continued with routine palliative care protocols. No therapeutic touch or other specific touch-based intervention was applied.

Control: Routine Palliative Care Group

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.

therapeutic touch intervention group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum City Hospital Palliative Care Service

Erzurum, Merkez, 02040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsFatigue Syndrome, ChronicFatigue

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This research was planned as a randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 13, 2026

Study Start

March 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations