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

Primary Purpose

Oncology, Fatigue, Patient

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Fatigue Self-management Programme

About this trial

This is an interventional supportive care trial for Oncology focused on measuring nursing, cancer patients, self-management, fatigue, activities of daily living, well-being, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zeynep KarakuşRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Controlled

Arm Description

Fatigue Self-management Programme

The control group received routine treatment and nursing care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04822220

First Posted

March 26, 2021

Last Updated

March 26, 2021

Sponsor

Akdeniz University

1. Study Identification

Unique Protocol Identification Number

NCT04822220

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 15, 2020 (Actual)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

January 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oncology, Fatigue, Patient

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Allocation

Randomized

Enrollment

94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Fatigue Self-management Programme

Arm Title

Controlled

Arm Type

No Intervention

Arm Description

The control group received routine treatment and nursing care

Intervention Type

Other

Intervention Name(s)

Fatigue Self-management Programme

Intervention Description

Fatigue Self-management Programme

Primary Outcome Measure Information:

Title

Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8

Description

The Brief Fatigue Inventory is a validated, self reported instrument assessing average fatigue.

Time Frame

Baseline, 2 week, 4 week, 8 week

Secondary Outcome Measure Information:

Title

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

Description

The Katz Index of Independence is a validated, self reported instrument assessing average daily living activities.

Time Frame

Baseline, 2 week, 4 week, 8 week

Title

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

Description

Well-Being Questionnaire (22 items) (W-BQ22) is a validated, self reported instrument assessing average well-being.

Time Frame

Baseline, 2 week, 4 week, 8 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zeynep KARAKUŞ

Phone

+902423102965

zeynepkarakus07@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zeynep Ozer, PhD, RN

Phone

+902423106126

zeynepcanli@akdeniz.edu.tr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zeynep Özer

Organizational Affiliation

Akdeniz University

Official's Role

Study Director

Facility Information:

Facility Name

Zeynep Karakuş

City

Antalya

ZIP/Postal Code

07058

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zeynep Karakuş

Phone

02423102965

12. IPD Sharing Statement

Plan to Share IPD

Yes

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

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