Clinical trial NCT05571098: The Effects of Nurse Navigation Program on Symptom Management and Psychosocial Adjustment in Colorectal Cancer Patients
Official title: The Effects of Nurse Navigation Program on Symptom Management and Psychosocial Adjustment Applied to Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Psycho-Oncology
Nursing
Keywords: Colorectal Cancer
Nurse Navigation Program
Psycho-Oncology
Symptom Management
Psychosocial Adjustment
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design type was determined as a randomized controlled experimental study with a pretest-posttest control group, with repeated measurements.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to examine the effect of the nurse navigation program (NNP) applied to patients with colorectal cancer on symptom management and psychosocial adjustment to the disease. The design type was determined as a randomized controlled experimental study with a pretest-posttest control group, with repeated measurements. For this purpose, individuals were divided into two groups as experimental (n=31) and control (n=31) groups. The study was carried out in Istanbul Lütfi Kırdar City Hospital Oncology Clinic between July 2021 and February 2022, after the necessary permissions were obtained. While individualized colorectal cancer education, psycho-oncological counseling and telephone support services were provided to the individuals in the experimental group under the guidance of nurse within the scope of NNP, no intervention was applied to the control group. In the study, data were collected with three different data collection tools: "Information Form", "Nightingale Symptom Assessment Scale (N-SAS)", "Psychosocial Adjustment To Illness Scale (PAIS/PAIS-SR)". Data were collected before NNP (once in the first week after chemotherapy), during NNP (once in the second week after chemotherapy, once in the first week after the next chemotherapy), after NNP (once in the second week after the next chemotherapy). The duration of the interventions performed via the WhatsApp application varied between 45-60 minutes between individuals. The research was completed with a total of 60 individuals, 30 in the experimental group and 30 in the control group. The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program.

Detailed description: Cancer is a leading cause of death worldwide, accounting for approximately 10 million deaths or one in six deaths in 2020 (WHO, 2022). According to cancer data published by GLOBOCAN 2020, colorectal cancer is the third most common cancer and the second most common cause of death among all cancer types (GLOBOCAN, 2020). Cancer, the incidence of which is increasing day by day, can cause serious mental problems and psychological effects in the social life of patients, as well as physical difficulties, and this situation negatively affects the course of the disease (Ülger et al, 2014). When the relevant literature is examined for colorectal cancer patients, pain, nausea, vomiting, impaired bowel function, anorexia and delirium are the most common symptoms in colorectal cancer patients (Kocakuşak et al, 2011; El-Shami et al, 2015). Many cancer patients experience psychosocial symptoms in addition to physical symptoms (Ülger et al, 2014). The most common psychosocial symptoms in cancer patients are usually adjustment disorders, depression, anxiety, decreased life satisfaction or loss of self-confidence (Akechi et al, 2001; Ateşci et al, 2003; Seven et al, 2013; Rashid et al, 2021). Since the treatment process of cancer includes a heavy and long process, it is important for patients to receive psycho-social support to protect their mental health and improve their ability to cope with the disease (Ülger et al, 2014). Patient navigation includes the services provided by professionals (navigators) trained in this field to provide education and support to individuals in overcoming the problems they encounter in the health care system, to encourage them to have cancer screenings, and to guide individuals (Dönmez, 2019). When the relevant literature is examined, although there are many studies on the use of navigation programs in cancer patients, no study on symptom management and psychosocial adjustment in individuals diagnosed with colorectal cancer has yet been found (Sussman et al, 2018; Loiselle et al, 2010; Nam et al, 2019; Young et al, 2010; Shum et al, 2014). In this context, the aim of this study is to examine the effect of the nurse navigation program applied to colorectal cancer patients on symptom management and psychosocial adjustment and to contribute to the relevant literature.

Eligibility criteria: Inclusion criteria:

* Being 18 years old and over
* Being colorectal cancer patient
* Having the capability to use WhatsApp application by themselves or their relatives
* Having adequate cognitive status
* Applying to the outpatient chemotherapy unit for chemotherapy treatment
* Volunteering to participate in the study

Exclusion criteria:

* Not knowing their own diagnosis
* Not having sufficient cognitive status
* Not being able to use WhatsApp by themselves or their relatives
* Having a communication barrier
* Not undergoing active chemotherapy
* Not volunteering to participate in the study

Primary outcomes:
measure: Nightingale Symptom Assessment Scale (N-SAS) scores should be lower in the NNP applied group than in the non-applied group.
timeFrame: 33 weeks
measure: Psychosocial Adjustment to Illness Scale (PAIS-SR) scores should be lower in the NNP applied group than in the non-applied group.
timeFrame: 33 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: University of Health Sciences
state: Üsküdar
Study officials:
affiliation: zeynep.dulger@sbu.edu.tr
name: Zeynep Dülger
role: PRINCIPAL_INVESTIGATOR
affiliation: elif.donmez@sbu.edu.tr
name: Elif Dönmez
role: STUDY_DIRECTOR
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