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Completed

NCT Number: NCT04822220

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Karakuş

Antalya, 07058, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fatigue Self-management Programme

Other

Fatigue Self-management Programme

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2021
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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