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

Not Applicable

Completed

• Conditions: Fatigue; Oncology; Patient

• Registration Number: NCT04822220
• Lead Sponsor: Akdeniz University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-15
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-30
• Primary Completion: 2022-04-20
• Study Completion: 2022-04-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-06
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8	Baseline, 2 week, 4 week, 8 week	The Brief Fatigue Inventory is a validated, self reported instrument assessing average fatigue.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in daily living activities on the Katz Index of Independence at week 8	Baseline, 2 week, 4 week, 8 week	The Katz Index of Independence is a validated, self reported instrument assessing average daily living activities.
Change From Baseline in well-being on Well-Being Questionnaire (22 items) (W-BQ22) at week 8	Baseline, 2 week, 4 week, 8 week	Well-Being Questionnaire (22 items) (W-BQ22) is a validated, self reported instrument assessing average well-being.

Trial Locations

Locations (1)

Zeynep Karakuş; 🇹🇷 Antalya, Turkey