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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04822220
• Other study ID #: 0002
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fatigue
• Oncology
• Patient

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