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Colorectal CancerNCT05571098

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

A study testing individualized colorectal cancer education, psycho-oncological counseling and telephone support hotline service in people with Colorectal Cancer and Psycho-Oncology, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Psycho-Oncology, Nursing
What is being tested?
individualized colorectal cancer education, psycho-oncological counseling and telephone support hotline service
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 Jul 2021to 24 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • University of Health Sciences

    Istanbul, Üsküdar

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Nurse Navigation Program on Symptom Management and Psychosocial Adjustment Applied to Patients With Colorectal Cancer

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.

Read the 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.

Being tested
individualized colorectal cancer education, psycho-oncological counseling, telephone support hotline service
Keywords
Colorectal Cancer, Nurse Navigation Program, Psycho-Oncology, Symptom Management, Psychosocial Adjustment
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • individualized colorectal cancer educationBehavioural

    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 counselingBehavioural

    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 serviceBehavioural

    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.

Study groups in NCT05571098
Study groupRoleWhat they receive
ExperimentalExperimentalIndividualized 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.
Receives: Behavioral: individualized colorectal cancer education; Behavioral: psycho-oncological counseling; Behavioral: telephone support hotline service
No interventionNo interventionNo intervention was applied to this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 33 weeks

  2. 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).

    Measured: 33 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2022
  2. Study start8 Jul 2021
  3. Primary completion24 Feb 2022
  4. Study completion24 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The design type was determined as a randomized controlled experimental study with a pretest-posttest control group, with repeated measurements.
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05571098
Sponsor's protocol ID
ZDULGER
Status last verified
Oct 2022
First submitted
24 Sep 2022
Last updated
7 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

  • 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.

  • 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.

    PubMed 26348643

  • 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.

    PubMed 11450992

  • 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.

    PubMed 12844281

  • 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.

  • 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).

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

  • 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.

    PubMed 29189967

  • 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.

    PubMed 19854604

  • 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.

    PubMed 30793862

  • 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.

    PubMed 19626346

  • 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.

  • 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.

    PubMed 19944644

  • 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.

    PubMed 3701670

Questions about this trial

What is this clinical trial studying?

A study testing individualized colorectal cancer education, psycho-oncological counseling and telephone support hotline service in people with Colorectal Cancer and Psycho-Oncology, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nightingale Symptom Assessment Scale (N-SAS) scores should be lower in the NNP applied group than in the non-applied group. (time frame: 33 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05571098, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.

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