The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Cancer Patients

NCT ID: NCT04822220

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2022-04-20

Brief Summary

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The purpose of this study is to evaluate the effect of Self-Management Program based on the Individual and Family Self-management Theory on fatigue, daily living activities and well-being of cancer patients.

Detailed Description

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Conditions

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Oncology Fatigue Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled trial consisting of two groups: experimental and control.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental

Fatigue Self-management Programme

Group Type EXPERIMENTAL

Fatigue Self-management Programme

Intervention Type OTHER

Fatigue Self-management Programme

Controlled

The control group received routine treatment and nursing care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fatigue Self-management Programme

Fatigue Self-management Programme

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Inpatients for symptom management or supportive care in oncology wards
* Patients who were at first two days of hospitalization
* Patients who had score of 3≤ or ≤7 in Fatigue Visual Analogue Scale (VAS)
* Patients who had score of ≤5 in Pain Analog Visual Scale (VAS)
* Patients who had score of ≤5 The Modified Borg Scale
* Patients who had score of 0, 1, 2 or 3 in ECOG Performance scale
* Patients who had metastases
* Patients who were over 18 years of age
* Patients who had orientation of person, place and time
* Patients who had no communication barriers
* Patients who agreed to participate in the study

Exclusion Criteria

* Patients who had hospitalized for the purpose of receiving chemotherapy
* Patients whose Hb value was ≤8 g / dl
* Patients whose body temperature ≥ 38.5 ° C within the last 24 hours
* Patients who had diarrhea in the last 24 hours (frequency of defecation ≥ 3 / day)
* Patients who had a score of ≤ 16 kg / m2 in Body Mass Index (BMI)
* Patients who had advanced heart failure
* Patients who had untreated hypothyroidism
* Patients who diagnosed with major depression and / or treated for depression
* Patients who had no family member involved in their care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep KARAKUŞ

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep Özer

Role: STUDY_DIRECTOR

Akdeniz University

Locations

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Zeynep Karakuş

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Karakus Z, Ozer Z. The effect of a fatigue self-management program based on individual and family self-management theory in cancer patients: A single-blinded randomized controlled trial. Eur J Oncol Nurs. 2024 Apr;69:102483. doi: 10.1016/j.ejon.2023.102483. Epub 2023 Dec 11.

Reference Type DERIVED
PMID: 38417400 (View on PubMed)

Other Identifiers

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0002

Identifier Type: -

Identifier Source: org_study_id

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