The Effects of Nurse Navigation Program on Symptom Management and Psychosocial Adjustment in Colorectal Cancer Patients

NCT ID: NCT05571098

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-08
• Study Completion Date: 2022-02-24

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.

Conditions

Colorectal Cancer; Psycho-Oncology; Nursing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental

Individualized colorectal cancer education, psycho-oncological counseling, and a nurse-managed telephone support hotline were provided to the individuals in the experimental group within the NNP. 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.

Group Type: EXPERIMENTAL

individualized colorectal cancer education

Intervention Type: BEHAVIORAL

Subjects taught within the scope of individualized colorectal cancer education:

• Common symptoms and management related to disease and treatment,
• Importance of nutrition in the treatment process.

psycho-oncological counseling

Intervention Type: BEHAVIORAL

Topics discussed within the scope of psycho-oncological counseling:

• Psychological state (anxiety, depression, etc.),
• Coping strategies about the process,
• Presence of fear about the disease and/or treatment,
• Lifestyle changes/problems,
• Changes in body image,
• Family/friendship/work-related concerns,
• Additional issues, comments he wishes to convey

telephone support hotline service

Intervention Type: BEHAVIORAL

Within the scope of the NNP, a telephone support hotline service was provided to the participants, where they could consult at any time about the subject they wanted.

No intervention

No intervention was applied to this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

individualized colorectal cancer education

Subjects taught within the scope of individualized colorectal cancer education:

• Common symptoms and management related to disease and treatment,
• Importance of nutrition in the treatment process.

Intervention Type: BEHAVIORAL

psycho-oncological counseling

Topics discussed within the scope of psycho-oncological counseling:

• Psychological state (anxiety, depression, etc.),
• Coping strategies about the process,
• Presence of fear about the disease and/or treatment,
• Lifestyle changes/problems,
• Changes in body image,
• Family/friendship/work-related concerns,
• Additional issues, comments he wishes to convey

Intervention Type: BEHAVIORAL

telephone support hotline service

Within the scope of the NNP, a telephone support hotline service was provided to the participants, where they could consult at any time about the subject they wanted.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Zeynep DÜLGER

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Dülger

Role: PRINCIPAL_INVESTIGATOR

zeynep.dulger@sbu.edu.tr

Elif Dönmez

Role: STUDY_DIRECTOR

elif.donmez@sbu.edu.tr

Locations

University of Health Sciences

Istanbul, Üsküdar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Related Links

https://www.who.int/news-room/fact-sheets/detail/cancer

World Health Organization (2020). Cancer.

https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf

GLOBOCAN (2020).

Other Identifiers

ZDULGER

Identifier Type: -

Identifier Source: org_study_id