Rhythmic therapeutic exercise program for breast cancer survivors
| ISRCTN | ISRCTN13777029 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13777029 |
| Secondary identifying numbers | 803/14-12-2022 |
- Submission date
- 06/01/2023
- Registration date
- 13/01/2023
- Last edited
- 03/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Worldwide, breast cancer is the most common type of cancer affecting women; however, nowadays, the survival rate is increasing. Cancer survivors commonly experience a range of medical and psychosocial consequences related to the disease and its treatment. Cancer-related fatigue (CRF) is recognized as one of the most common and distressing side effects, which has a negative impact on work performance, mood, and daily activities and causes significant impairment in overall quality of life.
Updated data on managing CRF's symptoms focus on exercise programs, physical activity, and psychosocial interventions. In recent years, rhythmic or music therapy methods are integrated into various physiotherapy interventions and studies are shown that patients have multiple therapeutic benefits. This study aims to develop a rhythmic therapeutic exercise program and evaluates its possible effects on cancer-related fatigue, physical activity, mental health, and quality of life of women with breast cancer.
Who can participate?
Women aged 45-60 years who are breast cancer survivors
What does the study involve?
This study involves:
1. The creation of an evidence-based intervention program of rhythmic therapeutic exercise (RhyKaTheA), suitable for breast cancer women survivors.
2. Personalized evaluation and intervention in matters of safe performance of the RhyKaTheA program
3. Checking the effectiveness of this novel program through this study
Participants will be randomly allocated to one of two groups; in the intervention group the RyKaTheA program will be implemented, while in the control group participants will be taught self-stretching of main muscle groups, which will be performed without supervision. They also will be encouraged to remain active but not to participate in any exercise program during the study's timeframe.
What are the possible benefits and risks of participating?
The primary expected outcome is reducing cancer-related fatigue and improving the functionality, mood, and quality of life of women with breast cancer. In addition, it is expected to determine the possible barriers and motivations for implementing the intervention and whether endogenous factors, such as dysthymia and other pathologies, impact the intervention's outcomes.
There are no notable risks to participating. Participation in the study is voluntary. Participants can refuse to participate or stop participating at any time. All information obtained for this study will be used for research purposes only and will be kept strictly confidential.
Where is the study run from?
1. University of West Attica (Greece)
2. Hellenic Cancer Society (Greece)
When is the study starting and how long is it expected to run for?
January 2023 to January 2028
Who is funding the study?
Hellenic Cancer Society (Greece)
Who is the main contact?
Dr Dafne Bakalidou, dbakalid@uniwa.gr
Contact information
Principal Investigator
Ag. Spyridonos str
Egaleo
Athens
12243
Greece
 ORCID ID |
0000-0003-3914-600X |
|---|---|
| Phone | +30 (0)6977691276 |
| dbakalid@uniwa.gr |
Scientific
Efst. and Stam. Valioti & Plataion Avenue, Sparta Campus, University of Pelopenese
Pelopenese
23100
Greece
| ORCID ID |
0000-0002-4238-2700 |
|---|---|
| Phone | + 30 27310 89689 |
| stasis@go.uop.gr |
Scientific
Ag. Spyridonos str
Egaleo
Athens
12243
Greece
| ORCID ID |
0000-0003-4750-6247 |
|---|---|
| Phone | +30 (0)6936724706 |
| melpidoforou@uniwa.gr |
Public
18-20 An. Tsoha str
Athens
115 21
Greece
| Phone | +30 (0)6936552255 |
|---|---|
| dioikisi@cancerhellas.org |
Study information
| Study design | Multicenter randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Other therapist office, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| Scientific title | Effectiveness of a rhythmic therapeutic-exercise program on cancer-related fatigue and quality of life of breast cancer women |
| Study acronym | RhyKaTheA |
| Study objectives | To investigate if a rhythmic therapeutic-exercise programme could increase functionality and reduce cancer-related fatigue. |
| Ethics approval(s) | Approved 14/12/2022, Hellenic Cancer Society Board of Directors (Hellenic Cancer Society, An. Tsoha 18-20, 115-21 Athens, Greece; +30 (0)210 3826600; +30 (0)210 6456713; dioikisi@cancerhellas.org), ref: 803/14-12-2022 |
| Health condition(s) or problem(s) studied | Fatigue in breast cancer survivors |
| Intervention | After the baseline assessment, participants will be randomly assigned to one of two groups: group A (intervention) or group B (control). The sample allocation will be carried out using the block randomization method (block size of 4). In group A, the RyKaTheA program will be implemented. In contrast, the participants of group B (control) will be taught self-stretching of main muscle groups, which will be performed without supervision. They will also be encouraged to remain active but not to participate in any exercise program during the study's timeframe. Participants will be assessed before the 8-week exercise program, immediately after, and 16 weeks after the program has finished. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Cancer-related fatigue will be evaluated using the Greek version of the Multidimensional Fatigue Inventory (MFI-Greek version) and the Greek version of the Modified Fatigue Impact Scale (MFIS) at baseline, 8, and 16 weeks 2. Functional mobility will be assessed using the Timed Up and Go Test at baseline, 8, and 16 weeks 3. Physical activity will be assessed using 6 minutes walking test (6MWS) at baseline, 8, and 16 weeks 4. Quality of life will be evaluated using the Greek version of the SF-36 Scale at baseline, 8, and 16 weeks |
| Secondary outcome measures | 1. Grip strength will be assessed using a hand dynamometer at baseline, 8, and 16 weeks 2. Lower limbs’ muscle strength will be assessed using the 30-sec sit-to-stand test at baseline, 8, and 16 weeks 3. Balance will be assessed using the Functional Reach Test at baseline, 8, and 16 weeks 4. Depression and anxiety will be assessed using the Greek version of the Depression, Anxiety and Stress Scale-21 (DASS-21) at baseline, 8, and 16 weeks |
| Overall study start date | 06/01/2023 |
| Completion date | 01/01/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 65 |
| Key inclusion criteria | 1. Breast cancer disease-free women aged 45-60 years (meaning that they completed their oncology treatment 2 to 6 months before enrollment in the study), except if they are receiving hormonotherapy 2. Willing to be assigned to any of the two study intervention groups |
| Key exclusion criteria | 1. Cognitive impairments 2. Neurological disorders 3. Cardiovascular diseases or high blood pressure not controlled with medication 5. Surgery on lower limbs affecting gait within the previous 6 months 6. Medical or other musculoskeletal problems that could affect the ability to complete objective assessments or exercise with safety 7. Cancer recurrence |
| Date of first enrolment | 01/03/2023 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Greece
Study participating centres
Athens
12243
Greece
Athens
115 21
Greece
Sponsor information
Other
18-20 An. Tsoha str.
Athens
11521
Greece
| Phone | +30 (0)2106456713 |
|---|---|
| dioikisi@cancerhellas.org | |
| Website | http://www.cancerhellas.org/ |
"ROR" |
https://ror.org/039p74p43 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be stored in a non-publically available repository. Access is only available to the corresponding author (Prof. Dafne Bakalidou) and the four additional researchers (Dr Stasi S, Elpidoforou M, and Dr Fillopoulos E). During recruitment, participants will be informed of the purposes of the study. Participants will agree to participate and will sign an informed consent form. Names of participants on the datasets will be replaced with codes, ensuring anonymisation (not applicable via weblink). Individual participant data collected during the trial will be available after de-identification (text, tables, figures, and appendices), beginning 9 months and ending 36 months following article publication. Access will be granted to researchers who provide a methodologically sound proposal in order for them to achieve the aims of the approved proposal. Proposals should be directed to dbakalidou@uniwa.gr. Data requestors need to sign a data access agreement to gain access. After 36 months, the data will not be available. |
Editorial Notes
03/03/2025: Contact details updated.
07/02/2025: The recruitment end date was changed from 01/03/2024 to 31/12/2026.
29/01/20/25: The following changes were made:
1. A study contact was removed.
2. The overall study end date was changed from 06/01/2025 to 01/01/2028.
3. The intention to publish date was changed from 01/03/2026 to 01/01/2029.
16/02/2023: The study setting has been changed from ‘Other’.
13/01/2023: Internal review.
11/01/2023: Trial's existence confirmed by the Hellenic Cancer Society.
