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

NCT06910917 | Completed

• 1 other identifier: MSKU-SBF-AT-03
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Psychosocial Adaptation; Psychological Resilience

Keywords

Breast cancer; Psychosocial Adaptation; Roy Adaptation Model; Nursing interventions; Psychological Resilience

Outcome Measures

Primary Outcomes (1)

• Psychosocial Adjustment to Illness Self-Report Scale (PAIS-SR)

  After obtaining the necessary permissions, women who participated in the study between December 2022 and November 2023 were provided with detailed face-to-face explanations about the research, and their written informed consent was obtained. The volunteers completed the scale forms in the hospital's psycho-oncology unit during six sessions, each lasting approximately 25-30 minutes.

  Baseline (pre-test) and 6 weeks after the intervention (post-test)

Secondary Outcomes (1)

• Psychological Resilience Scale (PRS)

  Baseline (pre-test) and 6 weeks after the intervention (post-test)

Study Arms (2)

Roy Adaptation Model-Based Nursing Interventions Group

EXPERIMENTAL

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.

Behavioral: Roy Adaptation-Based Nursing Interventions

Control Group (without any intervention)

NO INTERVENTION

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.

Interventions

Roy Adaptation-Based Nursing Interventions BEHAVIORAL

After the research groups were formed, a six-session interview program was created for the participants in the experimental group. Individual goals were set for the participants in the experimental group by combining the evaluations of the areas related to the psychosocial adaptation brought by the disease (physiological, self-concept, role function, interdependence) and the stimuli that would disrupt the adaptation (focus, affecting and possible) and nursing interventions were determined in line with these goals. applied. In the sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping) based on the Roy Adaptation Model were carried out for the negative situations caused by anxiety and anxiety experienced by individuals. It was applied to the participants as standard.

Roy Adaptation Model-Based Nursing Interventions Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study included only female participants, as it focused on women newly diagnosed with breast cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aytuğ Türk: lead
• Ege University: collaborator

Study Sites (1)

Ege University

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: After the research groups were formed, a six-session interview program was created for the participants in the experimental group. Individual goals were established by evaluating the psychosocial adjustment areas (physiological, self-concept, role function, interdependence) related to the disease and the stressors that could disrupt this adjustment (focus, characteristics). Nursing interventions were then applied in line with these goals. During the sessions, nursing and psychiatric nursing interventions based on the Roy Adaptation Model were implemented to address the anxiety experienced by individuals and the negative situations caused by that anxiety (such as psychoeducation, relaxation, mindfulness, and effective coping). Subjective goals were set for participants regarding the adaptive or maladaptive behaviors, attitudes, and thought patterns caused by the disease, and appropriate nursing interventions were applied from the Nursing Interventions Classification (NIC) system. Consid

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: April 4, 2025
• Study Start: November 2, 2022
• Primary Completion: December 10, 2023
• Study Completion: March 14, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 31.12.2-24-31.02.2025
• Access Criteria: Researchers specializing in women and individuals with cancer will have access.

Locations

TU (1)