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Clinical Trials/NCT04822220
NCT04822220
Completed
Not Applicable

The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Fatigue, Daily Life Activities and Wellness on Cancer Patients

Akdeniz University1 site in 1 country94 target enrollmentNovember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oncology
Sponsor
Akdeniz University
Enrollment
94
Locations
1
Primary Endpoint
Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2020
End Date
April 20, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zeynep KARAKUŞ

Research Assistant

Akdeniz University

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8

Time Frame: Baseline, 2 week, 4 week, 8 week

The Brief Fatigue Inventory is a validated, self reported instrument assessing average fatigue.

Secondary Outcomes

  • Change From Baseline in daily living activities on the Katz Index of Independence at week 8(Baseline, 2 week, 4 week, 8 week)
  • Change From Baseline in well-being on Well-Being Questionnaire (22 items) (W-BQ22) at week 8(Baseline, 2 week, 4 week, 8 week)

Study Sites (1)

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