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

NCT04822220 | Completed

• 1 other identifier: 0002
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Fatigue; Patient

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in daily living activities on the Katz Index of Independence at week 8

  Baseline, 2 week, 4 week, 8 week

• Change From Baseline in well-being on Well-Being Questionnaire (22 items) (W-BQ22) at week 8

  Baseline, 2 week, 4 week, 8 week

Study Arms (2)

Experimental

EXPERIMENTAL

Fatigue Self-management Programme

Other: Fatigue Self-management Programme

Controlled

NO INTERVENTION

The control group received routine treatment and nursing care

Interventions

Fatigue Self-management Programme OTHER

Fatigue Self-management Programme

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Zeynep Karakuş

Antalya, 07058, Turkey (Türkiye)

Location

Related Publications (1)

• Karakus Z, Ozer Z. The effect of a fatigue self-management program based on individual and family self-management theory in cancer patients: A single-blinded randomized controlled trial. Eur J Oncol Nurs. 2024 Apr;69:102483. doi: 10.1016/j.ejon.2023.102483. Epub 2023 Dec 11.

  PMID: 38417400 DERIVED

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeynep Özer

  Akdeniz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

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

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: November 15, 2020
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)