- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512817
The Effect of Online Solution- Focused Group Counseling On Adjustment, Psychological Well- Being and Resilience
The Effect of Online Solution- Focused Group Counseling On Adjustment, Psychological Well- Being and Resilience in Individuals: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancers are among the most frequently diagnosed cancer types both in our country and worldwide and constitute a major public health problem that leads to morbidity and mortality despite advanced diagnostic and treatment methods. Their high prevalence necessitates action to protect both individual and public health. The treatment of colorectal cancers includes radiotherapy (RT), chemotherapy (CT), antibody therapy, and surgical interventions. Surgical procedures for colon cancer vary depending on the location of the tumor. As a result of these surgical interventions, an ostomy may be created for reasons such as saving the patient's life, protecting the anastomosis line, or eliminating the necessity of the anus.
The term ostomy is derived from the Greek word stoma, meaning "mouth" or "opening." In medical terminology, a stoma/ostomy refers to a surgically created opening of a hollow organ onto the body surface to allow the elimination of waste products. Colostomy is one of the most common therapeutic interventions applied in pathological conditions of the colon, particularly colorectal cancer, and is defined as the exteriorization of the large intestine onto the skin.
Studies indicate that living with a colostomy affects individuals' overall quality of life. Patients with a stoma face not only physical and functional challenges but also psychological, emotional, and social losses. The presence of a colostomy has been associated with various complex problems, including psychological and sexual difficulties, dissatisfaction with altered body image, changes in daily routines, travel difficulties, and fatigue.
Changes occurring in the lives of individuals with a colostomy significantly affect their interpersonal and intimate relationships. Adopting a new lifestyle adapted to colostomy management may have an emotional impact on the patient as well as on close individuals such as family members and sexual partners. According to previous studies, married individuals experience major changes in their sexual lives, particularly immediately after surgery or during the early stages of the disease. Moreover, women have been found to have lower quality of life compared to men, a situation associated with body image changes, fear of rejection, and inability to perform household tasks. As having a colostomy may lead to partial or complete job loss, the professional lives of colostomy patients are also seriously affected.
Individuals with a colostomy encounter various physiological, psychological, and social challenges. Psychological resilience plays a crucial role in coping with these difficulties. Psychological resilience is defined as a dynamic process of positive adaptation in the face of significant adversity. Research has shown that individuals reporting higher levels of psychological resilience engage more frequently in health-promoting behaviors compared to those with lower resilience. Furthermore, individuals with higher psychological resilience demonstrate better adaptation to chronic illnesses than those with lower resilience. However, research on psychological resilience in individuals with permanent ostomies remains limited.
Studies have demonstrated that as psychological resilience increases in individuals with permanent ostomies, their adaptation to the ostomy also improves. Another study reported that decreases in psychological resilience among individuals with permanent ostomies were associated with reductions in health-related quality of life. In a study conducted by Dong X and colleagues (2017), a positive relationship was found between psychological resilience and post-traumatic growth.
Solution-focused counseling is a strengths-based approach that emphasizes the resources individuals already possess and how these resources can be applied in the process of change. This approach aims to facilitate change in individuals' lives in the shortest possible time. It is based on the belief that change originates from two main sources: encouraging individuals to define their preferred future (how their lives would look if therapy were successful) and detailing the skills and resources they have already demonstrated (examples of current and past successes).
A review of the literature revealed no studies investigating the effects of solution-focused group counseling in individuals with permanent colostomies. Therefore, understanding the effects of online solution-focused group counseling on adaptation, psychological well-being, and psychological resilience in individuals with permanent colostomies due to colorectal cancer is of great importance for the entire healthcare team, particularly for mental health and psychiatric nurses, who constitute a vital component of this team.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye)
- Hacettepe University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Being 18 years of age or older,
- Having a permanent colostomy due to colorectal cancer,
- At least 2 months having passed since the permanent colostomy was placed,
- Being able to use computers and online applications,
- Having no problems with verbal and written communication,
- Not having any physical or mental condition that would prevent cooperation.
Exclusion Criteria:
- Having previously had an ostomy • Having received psychotherapy in the last year or currently receiving it.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Solution- focused group counseling
Solution- focused group counseling to be carried out with the experimental group is planned as 6 sessions.The sessions are planned to be held in 3 groups of 8 people each.
The duration of a session is planned to be approximately 90 minutes.
Group counseling with the experimental group will be carried out online every week.The appropriate day for the sessions will be decided together with the member of each group.
The same group session will be held on the same day and time.
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After the follow-up tests will be completed, it is planned to apply 6 sessions group counseling to the intervention group in the same way to the control group, upon their request.
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No Intervention: Control
Control group will not receive any intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adaptation of the ostomy adjustment
Time Frame: Pre-intervention, immediately after the intervention, 3rd month follow-up
|
Adaptation of the ostomy adjustment scale, developed by Simmons et al. (2009), was adapted into Turkish by Karadağ et al. (2011). The scale consists of 23 items and includes four subscales: Acceptance, Anxiety/Concern, Social Adjustment, and Anger. It is structured as a 5-point Likert-type scale and is scored on a range from 0 to 4 (strongly agree, agree, undecided, disagree, strongly disagree). The total scale score ranges between 0 and 92. Higher scores obtained from each item indicate a higher level of adjustment. BTwelve items in the scale (items 2, 5, 7, 8, 10, 11, 12, 13, 16, 17, 18, and 21) contain negatively worded statements and are therefore reverse-coded. For positively coded items, responses are scored from 0 to 4, whereas for reverse-coded items, scoring is applied from 4 to 0. In the Turkish version of the scale, the overall Cronbach's alpha coefficient was calculated as .93. |
Pre-intervention, immediately after the intervention, 3rd month follow-up
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Psychological Well-Being
Time Frame: Pre-intervention, immediately after the intervention, 3rd month follow-up
|
The Psychological Well-Being Scale, developed by Diener et al. (2009; 2010), was adapted into Turkish by Telef (2011; 2013). The scale is unidimensional and consists of eight items. Items of the Psychological Well-Being Scale are rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). All items are positively worded. Total scores range from 8 (if strongly disagree is selected for all items) to 56 (if strongly agree is selected for all items), with higher scores indicating that the individual possesses greater psychological resources and strengths. In the Turkish version of the scale, the overall Cronbach's alpha coefficient was calculated as .80. |
Pre-intervention, immediately after the intervention, 3rd month follow-up
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Resilience
Time Frame: Pre-intervention, immediately after the intervention, 3rd month follow-up
|
The Resilience Scale for Adults, developed by Friborg et al. (2003), was adapted into Turkish by Basım and Çetin (2011). The scale consists of 33 items and includes six subscales: Perception of Self, Perception of Future, Structured Style, Social Competence, Family Cohesion, and Social Resources. It is a 5-point Likert-type scale presented in five response options. The scale does not have a specific cut-off score. Items numbered 1, 3, 4, 8, 11, 12, 13, 14, 15, 16, 23, 24, 25, 27, 31, and 33 are reverse-coded. For positively coded items, responses are scored from 1 to 5, whereas for reverse-coded items, scoring is applied from 5 to 1. In the Turkish version of the scale, the overall Cronbach's alpha coefficient was calculated as .86, while the Cronbach's alpha values for the subscales ranged between .66 and .81. |
Pre-intervention, immediately after the intervention, 3rd month follow-up
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Vonk-Klaassen SM, De Vocht HM, den Ouden MEM, Eddes EH, Schuurmans MJ. (2016). Ostomy-related problems and their impact on quality of life of colorectal cancer ostomates: a systematic review. Quality of life research, 25(1), 125-133.
- Tirgari B, Forouzi MA, Heidarzadeh A, Ganjalikhani MK (2023). Does Resilience Predict Ostomy Adjustment in Patients With Permanent Ostomy? Journal of Wound Ostomy & Continence Nursing, 50(5), 386-391.
- Stavropoulou A, Vlamakis D, Kaba E, Kalemikerakis I, Polikandrioti M, Fasoi G, Kelesi M (2021). "Living with a stoma": Exploring the lived experience of patients with permanent colostomy. International Journal of Environmental Research and Public Health, 18(16), 8512.
- Shaffy Kaur S, Das K, Gupta R (2012). Physical, nutritional and sexual problems experienced by the patients with colostomy/ileostomy: a qualitative study. Nursing & Midwifery Research Journal, 8(3), 210-222.
- Scardillo J, Dunn KS, Piscotty Jr R (2016). Exploring the relationship between resilience and ostomy adjustment in adults with a permanent ostomy. Journal of Wound Ostomy & Continence Nursing, 43(3), 274-279.
- Kenderian S, Stephens EK, Jatoi A. Ostomies in rectal cancer patients: what is their psychosocial impact? Eur J Cancer Care. 2014;23(3):328-32.
- Iveson C, George E, Ratner H (2012). Brief coaching: A solution focused approach. Routledge.
- Friborg O, Hjemdal O, Rosenvinge J, Martinussen M (2003). A new rating scale for adult resilience: what are the central protective resources behind healthy adjustment? International Journal of Methods in Psychiatric Research.12(2):65-77.
- Favoriti P, Carbone G, Greco M, Pirozzi F, Pirozzi REM, Corcione F (2016). Worldwide burden of colorectal cancer: a review. Updates in surgery, 68, 7-11.
- El-Rahman Mohamed MA, El-Ata ABA, &Elezaby HH (2022). Relationship between resilience and health-related quality of life among patients with a permanent colostomy. British Journal of Nursing, 31(6), S4-S12.
- Edwards MS, Chadda S, Zhao Z, Barber BL, Sykes DP (2012). A systematic review of treatment guidelines for metastatic colorectal cancer. Colorectal Disease, 14(2), 31-47.
- Düzköylü Y, Bektaş H, Sarı YS, Koç O, Bilsel Y, Güneş ME. Akut mekanik barsak obstrüksiyonu nedeniyle opere edilen kolorektal kanser olgularının elektif şartlarda ameliyat edilen olgularla karşılaştırılması. Kolon Rektum Hastalıkları Dergisi, 2013; 23:89-95.
- Dong X, Li G, Liu C, Kong L, Fang Y, Kang X, Li P (2017). The mediating role of resilience in the relationship between social support nd posttraumatic growth among colorectal cancer survivors with permanent intestinal ostomies: A structural equation model analysis. European Journal of Oncology Nursing, 29, 47-52.
- Danielsen AK, Soerensen EE, Burcharth K, Rosenberg J. Learning to live with a permanent intestinal ostomy: impact on everyday life and educational needs. J Wound Ostomy Continence Nurs. 2013;40(4):407-12.
- Corcoran, J., & Pillai, V. (2009). A review of the research on solution-focused therapy. British Journal of Social Work, 39(2), 234-242.
- Cohen J (1988). Statistical Power Analysis for the Behavioral Sciences. (2nd Ed.).Hillsdale, NJ: Lawrence Erlbaum.
- Capilla-Díaz C, Bonill-de Las Nieves C, Hernández-Zambrano SM, Montoya-Juárez R, Morales-Asencio JM, Pérez-Marfil MN, Hueso-Montoro C (2019). Living with an intestinal stoma: A qualitative systematic review. Qualitative health research, 29(9), 1255-1265.
- Basım HN, Çetin F (2011). Yetişkinler için Psikolojik Dayanıklılık Ölçeği'nin güvenilirlik ve geçerlilik çalışması. Türk Psikiyatri Dergisi.22(2):104-114.
- Andrade RS, de Medeiros LP, Freitas LS, Queiroz CG, Lucena SKP, de Vasconcelos Torres G (2016). Quality Of Life Regarding People With An Ostomy: Integrative Review About Related Factors. International Archives of Medicine, 9.
- Ambe PC, Kurz NR, Nitschke C, Odeh SF, Möslein G, Zirngibl H (2018). Intestinal ostomy: classification, indications, ostomy care and complication management. Deutsches Ärzteblatt International, 115(11), 182.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025 - 1477
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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