Reborn Lifestyle Adjustment Program

NCT06608043 | Recruiting

• 1 other identifier: E-22686390-050.99-46613
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Quality of Life

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• European Organization for Research and Treatment of Cancer Quality of Life Scale

  12 weeks

• University of Rhode Island Scale for Assessing Change

  Baseline

• Mini Mental Status Examination Test

  Baseline

• Visual Analog Scale

  12 weeks

Study Arms (2)

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

Control Group

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

Procedure: Conventional Physiotherapy and Occupational Therapy

Interventions

Reborn lifestyle adjustment program 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.

Intervention Group

Conventional Physiotherapy and Occupational Therapy PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients with breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Sena Ondes, MSc

  Atlas University

  STUDY CHAIR

Central Study Contacts

Sena Ondes, MSc

CONTACT

+905387094535; senaaondes@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)