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
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 |
Verified date | January 2024 |
Source | Akdeniz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Zeynep Karakus | Antalya |
Lead Sponsor | Collaborator |
---|---|
Akdeniz University |
Turkey,
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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