Reborn Lifestyle Adjustment Program

NCT ID: NCT06608043

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-08-01

Brief Summary

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The aim of this study is to investigate the effects of the reborn lifestyle regulation program on physical activity, fatigue level, pain, mental health burden and quality of life in breast cancer patients.

Detailed Description

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Conditions

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Breast Cancer Quality of Life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Intervention Group

This intervention group consists of multi-component modules developed to help individuals with breast cancer adopt a healthy lifestyle and improve their quality of life. The sessions are based on the 'Do Live Well' model, Kolb's Experiential Learning Theory, and CBT-based problem-solving skills.

Reborn lifestyle adjustment program

Intervention Type BEHAVIORAL

The sessions are based on the 'Do Live Well' model, Kolb's Experiential Learning Theory, and CBT-based problem-solving skills.

Introduction to the Reborn Lifestyle: Core principles of the Reborn Program for building a healthy lifestyle during and after breast cancer.

Physical Activity: The role of physical activity during treatment and exercises to boost energy levels.

Fatigue Management: Scientific methods for managing fatigue during and after treatment.

Pain Management: Effective techniques to reduce pain and improve quality of life.

Mental Health Burden: Strategies to alleviate mental health burdens and cope with stress.

Quality Sleep: Practical methods to improve sleep patterns and achieve quality rest.

Preventive Rehabilitation Approaches: Essential rehabilitation strategies to protect health and reduce recurrence risk.

The study will be conducted online, with evaluations and sessions via Zoom before and after the 12-week modules.

Control Group

Patients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions.

Conventional Physiotherapy and Occupational Therapy

Intervention Type PROCEDURE

Patients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions.

Interventions

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Reborn lifestyle adjustment program

The sessions are based on the 'Do Live Well' model, Kolb's Experiential Learning Theory, and CBT-based problem-solving skills.

Introduction to the Reborn Lifestyle: Core principles of the Reborn Program for building a healthy lifestyle during and after breast cancer.

Physical Activity: The role of physical activity during treatment and exercises to boost energy levels.

Fatigue Management: Scientific methods for managing fatigue during and after treatment.

Pain Management: Effective techniques to reduce pain and improve quality of life.

Mental Health Burden: Strategies to alleviate mental health burdens and cope with stress.

Quality Sleep: Practical methods to improve sleep patterns and achieve quality rest.

Preventive Rehabilitation Approaches: Essential rehabilitation strategies to protect health and reduce recurrence risk.

The study will be conducted online, with evaluations and sessions via Zoom before and after the 12-week modules.

Intervention Type BEHAVIORAL

Conventional Physiotherapy and Occupational Therapy

Patients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Being a female individual aged 18 or older
* Have been diagnosed with Stage I, II, or III breast cancer
* At least 6 months have passed since the completion of chemotherapy
* Approval by an oncologist to participate in the study
* Having internet access and the ability to connect online
* Scoring above 23 on a standardized Mini Mental Status Examination Test
* Being in the contemplation stage according to the Transtheoretical Model

Exclusion Criteria

* Having a neurological or systemic disease that could significantly affect the course of the intervention
* Having metastasis that could impact the sustainability of the study
* Suffering from neuropathic pain
* Having participated in a healthy lifestyle program within the last 3 months
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Atlas University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sena Ondes, MSc

Role: STUDY_CHAIR

Atlas University

Locations

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Istanbul Atlas University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sena Ondes, MSc

Role: CONTACT

+905387094535

Facility Contacts

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Sena Öndeş, MSc

Role: primary

+905387094535

Zeynep Bahadır, PhD

Role: backup

Sena Erarslan, MSc

Role: backup

Meryem Aksarı Gedikli, MSc

Role: backup

Sena Öndeş, MSc

Role: backup

Hülya Yaman, MSc

Role: backup

Other Identifiers

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E-22686390-050.99-46613

Identifier Type: -

Identifier Source: org_study_id

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