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

NCT05571098 | Completed

• 1 other identifier: ZDULGER
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Psycho-Oncology; Nursing

Keywords

Colorectal Cancer; Nurse Navigation Program; Psycho-Oncology; Symptom Management; Psychosocial Adjustment

Outcome Measures

Primary Outcomes (2)

• 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).

  33 weeks

• 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).

  33 weeks

Study Arms (2)

Experimental

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.

Behavioral: individualized colorectal cancer education; Behavioral: psycho-oncological counseling; Behavioral: telephone support hotline service

No intervention

NO INTERVENTION

No intervention was applied to this group.

Interventions

individualized colorectal cancer education 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.

Experimental

psycho-oncological counseling 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

Experimental

telephone support hotline service 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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences

Istanbul, Üsküdar, Turkey (Türkiye)

Location

Related Publications (16)

• Ülger E, Alacacıoğlu A, Gülseren AŞ, Zencir G, Demir L, Tarhan MO. Psychosocial Problems in Cancer and The Importance of Psychosocial Oncology. Journal of Dokuz Eylul University Medical Faculty. 2014; 28(2): 85-92.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26348643 BACKGROUND

• 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.

  PMID: 11450992 BACKGROUND

• Atesci FC, Oguzhanoglu NK, Baltalarli B, Karadag F, Ozdel O, Karagoz N. [Psychiatric disorders in cancer patients and associated factors]. Turk Psikiyatri Derg. 2003 Summer;14(2):145-52. Turkish.

  PMID: 12844281 BACKGROUND

• 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.

  BACKGROUND

• 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).

  BACKGROUND

• Dönmez E. Use of Navigation Systems. In: Can G, editors. Oncology nursing. Istanbul: Nobel Medical Bookstore; 2019. p. 1295-1301.

  BACKGROUND

• 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.

  PMID: 29189967 BACKGROUND

• Loiselle CG, Edgar L, Batist G, Lu J, Lauzier S. The impact of a multimedia informational intervention on psychosocial adjustment among individuals with newly diagnosed breast or prostate cancer: a feasibility study. Patient Educ Couns. 2010 Jul;80(1):48-55. doi: 10.1016/j.pec.2009.09.026. Epub 2009 Oct 24.

  PMID: 19854604 BACKGROUND

• Nam KH, Kim HY, Kim JH, Kang KN, Na SY, Han BH. Effects of social support and self-efficacy on the psychosocial adjustment of Korean ostomy patients. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):13-20. doi: 10.1111/iwj.13038.

  PMID: 30793862 BACKGROUND

• Young J, Harrison J, Solomon M, Butow P, Dennis R, Robson D, Auld S. Development and feasibility assessment of telephone-delivered supportive care to improve outcomes for patients with colorectal cancer: pilot study of the CONNECT intervention. Support Care Cancer. 2010 Apr;18(4):461-70. doi: 10.1007/s00520-009-0689-0. Epub 2009 Jul 22.

  PMID: 19626346 BACKGROUND

• Shum NF, Lui YL, Law WL, Fong YTD. A nurse-led psycho-education programme for Chinese carers of patients with colorectal cancer. Cancer Nursing Practice. 2014;13(5): 31-39.

  BACKGROUND

• Can G, Aydiner A. Development and validation of the Nightingale Symptom Assessment Scale (N-SAS) and predictors of the quality of life of the cancer patients in Turkey. Eur J Oncol Nurs. 2011 Feb;15(1):3-11. doi: 10.1016/j.ejon.2009.10.010. Epub 2009 Nov 26.

  PMID: 19944644 BACKGROUND

• Derogatis LR. The psychosocial adjustment to illness scale (PAIS). J Psychosom Res. 1986;30(1):77-91. doi: 10.1016/0022-3999(86)90069-3.

  PMID: 3701670 BACKGROUND

• Adaylar AM. Attitude, adaptation, perception and self-care orientations of individuals with chronic disease. PhD Thesis. Istanbul: Istanbul University, Institute of Health Sciences; 1995.

  BACKGROUND

Related Links

• World Health Organization (2020). Cancer.
• GLOBOCAN (2020).

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zeynep Dülger

  zeynep.dulger@sbu.edu.tr

  PRINCIPAL INVESTIGATOR

• Elif Dönmez

  elif.donmez@sbu.edu.tr

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: The design type was determined as a randomized controlled experimental study with a pretest-posttest control group, with repeated measurements.

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: October 7, 2022
• Study Start: July 8, 2021
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

TU (1)