Breast Cancer, Quality of Life
Conditions
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.
Interventions
BEHAVIORALReborn 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.
PROCEDUREConventional Physiotherapy and Occupational Therapy
Patients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions.
Sponsors
Atlas University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 12 weeks | 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. |
| Sit up Test | 12 weeks | 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. |
| Cancer Fatigue Scale | 12 weeks | 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). |
| McGill-Melzack Pain Questionnaire | 12 weeks | 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. |
| Depression Anxiety Stress Scale (DASS-21) | 12 weeks | 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. |
| Breast Cancer Specific Quality of Life Scale | 12 weeks | 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. |
| Modified Borg Scale | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| University of Rhode Island Scale for Assessing Change | Baseline | 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. |
| Mini Mental Status Examination Test | Baseline | 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. |
| Visual Analog Scale | 12 weeks | 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. |
| European Organization for Research and Treatment of Cancer Quality of Life Scale | 12 weeks | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactSena Ondes, MSc
Outcome results
None listed