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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04822220
Other study ID # 0002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2020
Est. completion date April 20, 2022

Study information

Verified date January 2024
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date April 20, 2022
Est. primary completion date April 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fatigue Self-management Programme
Fatigue Self-management Programme

Locations

Country Name City State
Turkey Zeynep Karakus Antalya

Sponsors (1)

Lead Sponsor Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8 The Brief Fatigue Inventory is a validated, self reported instrument assessing average fatigue. Baseline, 2 week, 4 week, 8 week
Secondary Change From Baseline in daily living activities on the Katz Index of Independence at week 8 The Katz Index of Independence is a validated, self reported instrument assessing average daily living activities. Baseline, 2 week, 4 week, 8 week
Secondary Change From Baseline in well-being on Well-Being Questionnaire (22 items) (W-BQ22) at week 8 Well-Being Questionnaire (22 items) (W-BQ22) is a validated, self reported instrument assessing average well-being. Baseline, 2 week, 4 week, 8 week
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