An interventional study of Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients in Cancer, Nurse's Role and Treatment Side Effects, sponsored by Akdeniz University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by Akdeniz University · Not applicable, Interventional, and Supportive care
Objective: The aim of this study was to determine the effects of nursing interventions based on Orem Self-Care Deficiency Theory on symptom management, care needs and quality of life in cancer patients who underwent immunotherapy.
Method: The research was planned as a randomized controlled trial. The research is planned to be carried out in the Medical Oncology unit of the Health Sciences University Antalya Training and Research Hospital. It is planned to be done with 58 patients, 29 experimental and 29 control groups. Based on Orem Self-Care Deficit Theory; face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned. Patient Description Form, Supportive Care Needs Scale-Short Form, Memorial Symptom Assessment Scale, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scale and Self-Care Strength Scale will be used to collect data.
Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Other: Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients
In this study, face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned to the experimental group.
Change from Baseline in Symptom on the Memorial Symptom Assessment Scale at week 12
Memorial Symptom Assessment Scale (MSAS): The Memorial Symptom Assessment Scale is a multidimensional self-report questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.The total score is the average of the responses to the distress scale items and and ranges from 0 to 4 with higher values indicating greater distress experienced from symptoms.
Time frame: Baseline and 12th week
Change from Baseline in Supportive Care Needs on the Supportive Care Needs Scale-Short Form at week 12
Supportive Care Needs Scale-Short Form: The 31-item instrument measures supportive care needs in five domains: health system and information, psychological needs, physical and daily living, patient care and support, and sexual-related. Responses are given on a scale from 1 to 5 where 1 = no help is needed and 5 = high need for help. Total scores range from 31 to 155 and higher scores indicate greater need for help.
Time frame: Baseline and 12th week
Change from Baseline in Self-Care Strength on the Self-Care Strength Scale at week 12
Self-Care Strength Scale: A maximum score of 140 is taken from the scale. The high score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual.
Time frame: Baseline and 12th week
Change from Baseline in Quality of Life Level on the EORTC QLQ-C30 Quality of Life Scale(European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) at week 12
EORTC QLQ-C30 Quality of Life Scale(European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire): This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.
Time frame: Baseline and 12th week
Change from Baseline in Adverse Events on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for 12 weeks
NCI-Common Terminology Criteria for Adverse Events Version 5.0: These algorithms provide support for prescribing the necessary treatment for grade 1 and grade 2 adverse events and for creating special care plans for grade 3 and 4 adverse events.
Time frame: Baseline,for 12 weeks
Plan to share: No
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Akdeniz University