Recruiting NCT06608043
Reborn Lifestyle Adjustment Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reborn lifestyle adjustment program, Conventional Physiotherapy and Occupational Therapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Quality of Life. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reborn Lifestyle Adjustment Program for Breast Cancer Patients
Overview
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.
Interventions
- Behavioral 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 technique - Procedure Conventional Physiotherapy and Occupational Therapy
Patients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions.
Primary outcome measures
- Breast Cancer Specific Quality of Life Scale [Time frame: 12 weeks]
- Modified Borg Scale [Time frame: 12 weeks]
- Sit up Test [Time frame: 12 weeks]
- Cancer Fatigue Scale [Time frame: 12 weeks]
- McGill-Melzack Pain Questionnaire [Time frame: 12 weeks]
- Depression Anxiety Stress Scale (DASS-21) [Time frame: 12 weeks]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: 12 weeks]
Secondary outcome measures (4)
- European Organization for Research and Treatment of Cancer Quality of Life Scale [Time frame: 12 weeks]
- University of Rhode Island Scale for Assessing Change [Time frame: Baseline]
- Mini Mental Status Examination Test [Time frame: Baseline]
- Visual Analog Scale [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Istanbul Atlas University — Istanbul
Identifiers
NCT: NCT06608043 · E-22686390-050.99-46613