Clinical trial · Interventional
The Effect of Roy Adaptation Model-Based Nursing Interventions on Psychological Resilience and Psychosocial Adjustment in Newly Diagnosed Breast Cancer Patients: A Randomized Controlled Trial
Yeni Tanı Almış Meme Kanseri Hastalarına Uygulanan Roy Adaptasyon Temelli Hemşirelik Müdahalelerinin Psikolojik Dayanıklılık ve Psikososyal Uyum Üzerine Etkisi
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Today, cancer has become a multifaceted problem whose diagnosis and treatment should be handled multidisciplinarily. In addition to being a medical-physical disease, cancer is a chronic phenomenon that involves many mental and psychosocial problems. Cancer patients develop various and different emotional, psychological and behavioral reactions during diagnosis, treatment, relapse and palliative periods. For this reason, holistic treatment and care of cancer patients should include medical, psychiatric and psychosocial dimensions together. Oncology, CLP and psychiatry nurses, who are important members of the team, have important duties in this regard. Accordingly, the study will be conducted with female individuals who applied to Ege University Tulay Aktas Oncology Hospital Psychooncology unit and were diagnosed with breast cancer within 6 months. The quasi-experimental method with pre-test post-test control group was used as the research method. In this context, the patients who applied to the relevant unit will be divided into two groups as experimental and control groups by simple randomization according to the order of application. SPSS 22 package program will be used in the evaluation of the data; statistical significance will be examined at 0.05 significance level. After the research groups are formed, a six-session interview program will be created for the participants in the experimental group. In the sessions, the most appropriate interventions based on the Roy Adaptation Model and the Nursing Interventions Classification System (Nursing Interventions Classification), including psychoeducation, adaptation to change, relaxation exercises, awareness, effective coping, problem solving, will be carried out for the negative situations that the disease and the disease may cause. At the end of each session, the evaluation of the interventions will be made according to the Nursing Outcomes Classification System. Individuals in the control group will not receive any intervention. The sub-concepts such as adaptation, stimulus, and behavior, which are considered and evaluated together within the conceptual framework of the Roy Adaptation model, are considered to be a highly suitable model for increasing psychosocial adaptation and psychological resilience in women newly diagnosed with breast cancer. The study data will be collected using the Individual Identification Form, Psychosocial Adjustment to Illness - Self-Report Scale and Psychological Resilience Scale. In addition to these scales that provide quantitative data, it is aimed to keep a researcher's diary during the sessions conducted by the researcher and to provide supportive data both for the evaluation of the needs and adaptation levels of the participants during the application process and for the evaluation of the application.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Psychological Resilience | — | UNRESOLVED | — |
| Psychosocial Adaptation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Roy Adaptation-Based Nursing Interventions | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Roy Adaptation Model-Based Nursing Interventions Group
- description
- A six-session program based on the Roy Adaptation Model was implemented for the experimental group, focusing on psychosocial adaptation (physiological, self-concept, role function, interdependence). Standard nursing interventions from NIC were applied, including enhancing coping, self-esteem, body image, and functional abilities. Outcomes were evaluated using NOC, and interventions were adjusted accordingly.
- interventionNames
- Behavioral: Roy Adaptation-Based Nursing Interventions
- type
- NO_INTERVENTION
- label
- Control Group (without any intervention)
- description
- Description: The control group received standard nursing care without additional interventions based on the Roy Adaptation Model. Their outcomes were monitored for comparison with the experimental group.
Primary outcomes (1)
- measure
- Psychosocial Adjustment to Illness Self-Report Scale (PAIS-SR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Being a female aged 18 or older * Having a confirmed breast cancer diagnosis within 0-6 months through clinical imaging and pathological examination * Not having undergone surgery since the diagnosis or not having surgery planned within the study period (approximately 2 months) to exclude the impact of nursing care during surgical procedures Exclusion Criteria: * Non-primary breast cancer * Presence of metastasis * Receiving psychosocial treatment or therapy support * Inability to attend sessions regularly * Use of psychiatric medication within the last three months * Having a low level of compliance
References
Publications (0)
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