Reborn Lifestyle Adjustment Program

Reborn Lifestyle Adjustment Program for Breast Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Breast Cancer
• Intervention / Treatment: Behavioral: Reborn lifestyle adjustment program; Procedure: Conventional Physiotherapy and Occupational Therapy

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Sena Öndeş, MSc; Phone Number: +905387094535; Email: senaaondes@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul Atlas University
    • Contact: Sena Öndeş, MSc; Phone Number: +905387094535; Email: senaaondes@gmail.com
    • Contact: Zeynep Bahadır, PhD
    • Contact: Sena Erarslan, MSc
    • Contact: Meryem Aksarı Gedikli, MSc
    • Contact: Sena Öndeş, MSc
    • Contact: Hülya Yaman, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Female patients with breast cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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 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.	Procedure: Conventional Physiotherapy and Occupational Therapy; Patients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast Cancer Specific Quality of Life Scale	An adjunct to the EORTC QLQ-C30, this scale assesses breast cancer-specific symptoms and treatment-related side effects. It includes subscales for body image, sexual function, and treatment side effects, rated on a 4-point Likert scale. The Turkish version was adapted by Demirci et al. in 2011.	12 weeks
Modified Borg Scale	Developed by Borg in 1970, this unidirectional scale (0-10) measures the effort exerted during physical exercise, particularly in assessing dyspnea severity. Participants rate their dyspnea over the past week, with "0" indicating no shortness of breath and "10" indicating severe shortness of breath.	12 weeks
Sit up Test	This test measures leg strength and endurance by counting how many times a participant can sit and stand from a chair within 30 seconds. A score of fewer than 10 sit-ups indicates lower extremity weakness. The Turkish validity and reliability were established by Demir and Öztürk in 2020.	12 weeks
Cancer Fatigue Scale	The CFS, developed by Okuyama et al. (2000) and validated in Turkish by Şahin et al. (2018), evaluates fatigue in individuals with cancer across three domains: physical, emotional, and cognitive. The scale consists of 15 items, rated on a Likert scale from 1 (not at all) to 5 (very much).	12 weeks
McGill-Melzack Pain Questionnaire	Developed by Melzack in the 1970s and validated in Turkish by Kuguoglu et al. (2003), the MPQ assesses the quality and intensity of pain through four sections, including sensory and perceptual dimensions. Scores range from 0 to 112, with higher scores indicating more severe pain.	12 weeks
Depression Anxiety Stress Scale (DASS-21)	The DASS-21, developed by Lovibond & Lovibond (1995) and validated in Turkish by Sarıçam (2018), assesses mental health across three dimensions: depression, anxiety, and stress. Each dimension consists of 7 items rated on a 4-point Likert scale. Higher scores indicate more severe symptoms.	12 weeks
Pittsburgh Sleep Quality Index (PSQI)	Developed by Buyyse et al. (1989) and validated in Turkish by Agargun et al., the PSQI assesses sleep quality over the past month across seven components. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Organization for Research and Treatment of Cancer Quality of Life Scale	This 30-item scale assesses the quality of life in cancer patients across three domains: global health, functional, and symptoms. Higher scores in functional and general health indicate better well-being, while higher symptom scores indicate more severe issues.	12 weeks
University of Rhode Island Scale for Assessing Change	This scale assesses individuals' readiness for change as part of the study's inclusion criteria. Developed by Prochaska et al. (1983), it consists of 32 items rated on a 5-point Likert scale. The scale has 4 sub-dimensions: pre-contemplation, contemplation, action, and maintenance. The Turkish validity and reliability were confirmed by Menekli and Fadiloglu (2012). Higher scores indicate a more positive attitude toward change.	Baseline
Mini Mental Status Examination Test	The MMSE will be used to determine cognitive levels for study inclusion. Developed by Folstein et al. in 1975, this tool assesses cognitive performance across five domains. The test is widely used due to its ease and quick administration. Scores range from 0 to 30, with a cut-off of 23/24, as validated in Turkish by Gungen et al.	Baseline
Visual Analog Scale	The VAS, developed by Hayes and Patterson (1921) and validated in Turkish by Aydın et al. (2011), is used to measure pain severity. A 10 cm line is marked from "no pain" to "unbearable pain," and the patient places a mark according to their pain level.	12 weeks

Collaborators and Investigators

• Sponsor: Atlas University
• Investigators: Study Chair: Sena Ondes, MSc, Atlas University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: E-22686390-050.99-46613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No