Reborn Lifestyle Adjustment Program
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAtlas University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Female patients with breast cancer
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Reborn lifestyle adjustment program
BehavioralThe 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.
Conventional Physiotherapy and Occupational Therapy
Procedure/SurgeryPatients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intervention Group1 intervention
Group B: Control Group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 weeks2
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.
Time frame
12 weeks3
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.
Time frame
12 weeks4
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).
Time frame
12 weeksSecondary outcomes
1
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.
Time frame
12 weeks2
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.
Time frame
Baseline3
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.
Time frame
Baseline4
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.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov