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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04822220
Enrollment
94
Registered
2021-03-30
Start date
2020-11-15
Completion date
2022-04-20
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Oncology, Patient

Keywords

nursing, cancer patients, self-management, fatigue, activities of daily living, well-being, randomized controlled trial

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.

Interventions

OTHERFatigue Self-management Programme

Fatigue Self-management Programme

Sponsors

Akdeniz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

This is a randomized controlled trial consisting of two groups: experimental and control.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8Baseline, 2 week, 4 week, 8 weekThe Brief Fatigue Inventory is a validated, self reported instrument assessing average fatigue.

Secondary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026