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

January 6, 2024 updated by: Zeynep KARAKUŞ, Akdeniz University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07058
        • Zeynep Karakuş

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8
Time Frame: Baseline, 2 week, 4 week, 8 week
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
Time Frame: Baseline, 2 week, 4 week, 8 week
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
Time Frame: Baseline, 2 week, 4 week, 8 week
Well-Being Questionnaire (22 items) (W-BQ22) is a validated, self reported instrument assessing average well-being.
Baseline, 2 week, 4 week, 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Study Director: Zeynep Özer, Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Actual)

April 20, 2022

Study Completion (Actual)

April 20, 2022

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fatigue

Clinical Trials on Fatigue Self-management Programme

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe