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

Primary Purpose

Colorectal Cancer, Psycho-Oncology, Nursing

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
individualized colorectal cancer education
psycho-oncological counseling
telephone support hotline service
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring Colorectal Cancer, Nurse Navigation Program, Psycho-Oncology, Symptom Management, Psychosocial Adjustment

Eligibility Criteria

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

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

Sites / Locations

  • University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

No intervention

Arm Description

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.

No intervention was applied to this group.

Outcomes

Primary Outcome Measures

Nightingale Symptom Assessment Scale (N-SAS) scores should be lower in the NNP applied group than in the non-applied group.
Nightingale Symptom Assessment Scale (N-SAS) is a quality of life scale developed by Gülbeyaz Can and Adnan Aydıner which evaluates the severity of symptoms developing in patients with cancer and its treatment. The scale consists of 38 items in total. The scale has three sub-dimensions: Physical Well-being (items 1-4, 6-15, 23-27 and 37), Social Well-being (items 5 and 16-22) and Psychological Well-being (items 28-36 and 38). The scale is in a 5-point Likert type, and the patient's response to the evaluated item is scored as "0" if it is no, "1" if it is very little, "2" if it is a little, "3" if it is quite a lot, and "4" if it is too much. A high score indicates that the level of being affected by the disease/treatment-related problems is high (Can and Aydiner, 2011).
Psychosocial Adjustment to Illness Scale (PAIS-SR) scores should be lower in the NNP applied group than in the non-applied group.
Psychosocial Adjustment to Illness Scale (PAIS-SR) is a scale developed in English by Derogatis in 1986, aiming to evaluate psychosocial adjustment to physical illness (Deragotis, 1986). The Turkish validity and reliability study of the PAIS-SR was carried out by Adaylar (1995). The scale, which consists of 46 items, has seven sub-dimensions: compliance with health care, occupational environment, home environment, sexual relations, extended family relations, social environment, and psychosocial pressure. The lowest score that can be obtained from the scale is 0, and the highest score is 138. Scores below 35 in the scale indicate "good psychosocial adjustment", scores between 35 and 51 indicate "moderate psychosocial adjustment", and scores above 51 indicate "poor psychosocial adjustment" (Adaylar, 1995).

Secondary Outcome Measures

Full Information

First Posted
September 24, 2022
Last Updated
October 4, 2022
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05571098
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Psycho-Oncology, Nursing
Keywords
Colorectal Cancer, Nurse Navigation Program, Psycho-Oncology, Symptom Management, Psychosocial Adjustment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The design type was determined as a randomized controlled experimental study with a pretest-posttest control group, with repeated measurements.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention was applied to this group.
Intervention Type
Behavioral
Intervention Name(s)
individualized colorectal cancer education
Intervention Description
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
Intervention Name(s)
psycho-oncological counseling
Intervention Description
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
Intervention Name(s)
telephone support hotline service
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nightingale Symptom Assessment Scale (N-SAS) scores should be lower in the NNP applied group than in the non-applied group.
Description
Nightingale Symptom Assessment Scale (N-SAS) is a quality of life scale developed by Gülbeyaz Can and Adnan Aydıner which evaluates the severity of symptoms developing in patients with cancer and its treatment. The scale consists of 38 items in total. The scale has three sub-dimensions: Physical Well-being (items 1-4, 6-15, 23-27 and 37), Social Well-being (items 5 and 16-22) and Psychological Well-being (items 28-36 and 38). The scale is in a 5-point Likert type, and the patient's response to the evaluated item is scored as "0" if it is no, "1" if it is very little, "2" if it is a little, "3" if it is quite a lot, and "4" if it is too much. A high score indicates that the level of being affected by the disease/treatment-related problems is high (Can and Aydiner, 2011).
Time Frame
33 weeks
Title
Psychosocial Adjustment to Illness Scale (PAIS-SR) scores should be lower in the NNP applied group than in the non-applied group.
Description
Psychosocial Adjustment to Illness Scale (PAIS-SR) is a scale developed in English by Derogatis in 1986, aiming to evaluate psychosocial adjustment to physical illness (Deragotis, 1986). The Turkish validity and reliability study of the PAIS-SR was carried out by Adaylar (1995). The scale, which consists of 46 items, has seven sub-dimensions: compliance with health care, occupational environment, home environment, sexual relations, extended family relations, social environment, and psychosocial pressure. The lowest score that can be obtained from the scale is 0, and the highest score is 138. Scores below 35 in the scale indicate "good psychosocial adjustment", scores between 35 and 51 indicate "moderate psychosocial adjustment", and scores above 51 indicate "poor psychosocial adjustment" (Adaylar, 1995).
Time Frame
33 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Dülger
Organizational Affiliation
zeynep.dulger@sbu.edu.tr
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elif Dönmez
Organizational Affiliation
elif.donmez@sbu.edu.tr
Official's Role
Study Director
Facility Information:
Facility Name
University of Health Sciences
City
İstanbul
State/Province
Üsküdar
Country
Turkey

12. IPD Sharing Statement

Citations:
Citation
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Kocakuşak A, Yaşar MA, Güler N, Görmüş C, Aydın S, Özer E, Benek S, Pamak S. Retrospective Evaluation of Patients Aged 45 Years or Younger Diagnosed with Colorectal Cancer. Med Bull Haseki 2011;49:110-113.
Results Reference
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PubMed Identifier
26348643
Citation
El-Shami K, Oeffinger KC, Erb NL, Willis A, Bretsch JK, Pratt-Chapman ML, Cannady RS, Wong SL, Rose J, Barbour AL, Stein KD, Sharpe KB, Brooks DD, Cowens-Alvarado RL. American Cancer Society Colorectal Cancer Survivorship Care Guidelines. CA Cancer J Clin. 2015 Nov-Dec;65(6):428-55. doi: 10.3322/caac.21286. Epub 2015 Sep 8.
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PubMed Identifier
11450992
Citation
Akechi T, Nakano T, Okamura H, Ueda S, Akizuki N, Nakanishi T, Yoshikawa E, Matsuki H, Hirabayashi E, Uchitomi Y. Psychiatric disorders in cancer patients: descriptive analysis of 1721 psychiatric referrals at two Japanese cancer center hospitals. Jpn J Clin Oncol. 2001 May;31(5):188-94. doi: 10.1093/jjco/hye039.
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PubMed Identifier
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Citation
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Seven M, Akyüz A, Sever N, Dinçer Ş. Studying the Physical and Psychological Symptoms of Patients with Cancer. TAF Preventive Medicine Bulletin. 2013; 12(3):219-224.
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Rashid A, Aqeel M, Malik B, Salim S. The prevalence of psychiatric disorders in breast cancer patients; a cross-sectional study of breast cancer patients experience in Pakistan. Nature-Nurture Journal of Psychology. 2021; 1(1).
Results Reference
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Citation
Dönmez E. Use of Navigation Systems. In: Can G, editors. Oncology nursing. Istanbul: Nobel Medical Bookstore; 2019. p. 1295-1301.
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29189967
Citation
Sussman J, Bainbridge D, Whelan TJ, Brazil K, Parpia S, Wiernikowski J, Schiff S, Rodin G, Sergeant M, Howell D. Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial. Support Care Cancer. 2018 May;26(5):1533-1541. doi: 10.1007/s00520-017-3981-4. Epub 2017 Nov 30.
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Citation
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Links:
URL
https://www.who.int/news-room/fact-sheets/detail/cancer
Description
World Health Organization (2020). Cancer.
URL
https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf
Description
GLOBOCAN (2020).

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

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