Breast CancerNCT06608043
Reborn Lifestyle Adjustment Program
An observational study of Breast Cancer and Quality of Life, run by Atlas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Quality of Life
- What is being tested?
- Reborn lifestyle adjustment program and Conventional Physiotherapy and Occupational Therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with breast cancer
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Atlas University
Istanbul
Sena Öndeş, MSc, +905387094535, senaaondes@gmail.com
Zeynep Bahadır, PhD
About this study
Official title: 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.
- Conditions
- Breast Cancer, Quality of Life
- Being tested
- Reborn lifestyle adjustment program, Conventional Physiotherapy and Occupational Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reborn lifestyle adjustment programBehavioural
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.
Conventional Physiotherapy and Occupational TherapyProcedure or surgery
Patients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reborn lifestyle adjustment program | |
| Control Group | Patients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions. Receives: Procedure: Conventional Physiotherapy and Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Aug 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sena Ondes, MSc, Study chair, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608043
- Sponsor's protocol ID
- E-22686390-050.99-46613
- Status last verified
- Aug 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reborn Lifestyle Adjustment Program for Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06608043
- Acronym / sponsor ID
- E-22686390-050.99-46613
- Conditions
- Breast Cancer, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Behavioral: Reborn lifestyle adjustment programThis 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. |
| Control Group | – | Procedure: Conventional Physiotherapy and Occupational TherapyPatients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with breast cancer
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reborn lifestyle adjustment programThe 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. | Behavioural | Intervention Group |
| Conventional Physiotherapy and Occupational TherapyPatients in the control group will continue conventional medical treatments, occupational therapy and physiotherapy sessions. | Procedure or surgery | Control Group |
Primary outcome
Breast Cancer Specific Quality of Life Scale
Time frame: 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
Time frame: 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.
Sit up Test
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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.
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sena Ondes, MSc study chair
Atlas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Quality of Life, run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sena Ondes, MSc (+905387094535, senaaondes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cancer Specific Quality of Life Scale (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.