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

Study Overview
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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.

Official Title
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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

Conditions
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Oncology, Fatigue, Patient

Intervention / Treatment
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* Other: Fatigue Self-management Programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were hospitalized at Akdeniz University Hospital Oncology Clinics Patients who were at first three 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 not an infection 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 72 hours after admission to the clinic 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized controlled trial consisting of two groups: experimental and control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Fatigue Self-management Programme | Other: Fatigue Self-management Programme<br>* Fatigue Self-management Programme<br>|
| No Intervention: Controlled<br>The control group received routine treatment and nursing care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nursing, cancer patients, self-management, fatigue, activities of daily living, well-being, randomized controlled trial