NCT04362904

Brief Summary

The aim of this study was to investigate the effect of acupressure on the severity and level of cancer-related fatigue in elderly patients with cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

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

August 4, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2016

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

April 17, 2020

Last Update Submit

April 23, 2020

Conditions

Keywords

AcupressureCancerFatigueElderly individualsNursing

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale

    The scale is a 10-cm scale starts with a -0- representing "I don't feel tired", the other end is -10- "I feel very tired". 0-3 points show mild fatigue, 4-6 points moderate fatigue, 7-10 points indicate severe fatigue. The patients were asked to mark how tired they were during the last week on a scale of 0 to 10. The distance between the marked point and the lowest end of the line (0 = no fatigue) was measured in centimeters by the ruler and the numerical value was determined as the fatigue score of the patients.

    four weeks

  • Piper Fatigue Scale

    The scale evaluates the patient's subjective perception of fatigue with four sub-dimensions. These sub-dimensions are behavioral/severity sub-dimension that evaluates effects and intensity of fatigue on daily life activity (DLA), affective meaning sub-dimension that includes emotional meaning attributed to fatigue, sensory sub-dimension that reflects spiritual, physical and emotional symptoms of fatigue and cognitive/mood sub-dimension that reflects the level of effects of fatigue on cognitive functions and state of mind. The high scores obtained from the scale indicate that the perceived fatigue level is high.The validity and reliability study of the scale for the Turkish population was conducted by Can and the cronbach alpha coefficient was found to be 0.94. The cronbach's alpha coefficient in this study was 0.79 in the first follow-up and 0.94 in the second follow-up.

    four weeks

Other Outcomes (1)

  • Acupressure Experience Patient Opinion Form

    four weeks

Study Arms (2)

acupressure

EXPERIMENTAL

In accordance with the acupressure protocol, each day for four weeks, taking into account the awakening and sleep periods of the individuals, acupressure applied for a total of 3 min to the each acupuncture points (one session 18 minutes) twice a day between 07:00 and 10:00 and 19:00 to 22:00 in the morning patients were asked to perform acupressure by their caregivers or on their own.

Other: acupressure

control

NO INTERVENTION

No intervention was applied to the control group.

Interventions

acupressure

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 and over
  • Who completed chemotherapy treatment for cancer at least a month ago
  • Least literate
  • Moderate to severe fatigue (VAS fatigue score 4 and above)
  • Platelet count\> 50,000
  • Hemoglobin levels\> 9 g / dl
  • Hematocrit levels\> 30%
  • Patients with an estimated survival time of more than three months

You may not qualify if:

  • Comorbidities that may cause fatigue (eg moderate and severe heart failure, hypothyroidism, diabetes, multiple sclerosis)
  • Being diagnosed with a psychiatric disease
  • Nerve, soft tissue and vascular disease on acupressure areas (hand and leg)
  • Infection and surgery operations on acupressure areas (hand and leg)
  • Patients had chemotherapy, radiotherapy or other cancer treatment planned during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FatigueNeoplasms

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • ülkü özdemir

    TC Erciyes University

    PRINCIPAL INVESTIGATOR
  • sultan taşcı

    TC Erciyes University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: a randomized, controlled trial in pre-test post-test design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor doctor

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 27, 2020

Study Start

August 4, 2014

Primary Completion

March 10, 2016

Study Completion

March 10, 2016

Last Updated

April 27, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

no panning