Breast CancerNCT04837248
Design and Evaluation of the Effects of a Physical Therapy Program With Digital Support in Patients With Breast Cancer
A study testing Active Comparator: Group 1. Conventional treatment and Experimental: Group 2. Experimental treatment. in people with Breast Cancer, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
Breast cancer surgery usually results in reduced range of motion of the shoulder joint, weakness of the musculature and altered scapular kinematics during movement. These factors limit activities of daily living, so rehabilitation exercises help to restore function after shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Active Comparator: Group 1. Conventional treatment and Experimental: Group 2. Experimental treatment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- 2 Aug 2021to 30 Dec 2024
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stage I, II or III of Breast cancer treated by surgery.
- Medical authorisation for participation.
- Internet access.
- Basic computer skills.
- Signed informed consent.
- No bilateral mastectomy.
Show all 12Show fewer
- No metastases.
- Post-intervention period of 10 days to 3 months.
- Age 18-85 years.
- No previous shoulder pathologies.
- No pathology that prevents exercise.
- Understanding of the Spanish language.
Who cannot join
- Breast cancer treated without surgery.
- Patient in severe psychiatric treatment who may present difficulties for participation in the study.
- Stage IV cancer.
- Any other clinical condition or previous therapy that contraindicates one or more of the techniques included in the programme, as the intervention may not be safe for the patient and therefore the person would not be eligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design and Evaluation of the Effects of a Physical Therapy Program With Digital Support in Patients With Breast Cancer Surgery. A Clinical Trial.
Breast cancer surgery usually results in reduced range of motion of the shoulder joint, weakness of the musculature and altered scapular kinematics during movement. These factors limit activities of daily living, so rehabilitation exercises help to restore function after shoulder surgery.
Women with breast cancer often have a life conditioned by the sequelae or morbidity secondary to the treatment of the disease and, despite the high cure rate, many patients are unable to regain their initial quality of life. Cancer therapies can leave physical, psychological and psychosocial sequelae, which may manifest themselves or persist even years after the end of treatment.
Read more
For all these reasons, patients who have undergone cancer treatment need physical rehabilitation as well as psychological and social care to support them in their new stage of life, and to optimise the rehabilitation programme, it is necessary to identify each patient's individual needs,
The digital support proposed in this study enables the development of a physiotherapy programme for patients with breast cancer in a situation of health crisis, which includes providing assistance, information, accompaniment, help and treatment to these patients in a comprehensive way, based on the biopsychosocial model.
Read the detailed description
DESIGN: Single-centre, assessor-blinded, parallel-group, randomised controlled clinical trial.
METHODS: The study will be carried out at the Ramon y Cajal hospital with 92 patients diagnosed and operated on for breast cancer.
Patients who come to the consultation of the rehabilitation doctors will be assessed, considering the inclusion and exclusion criteria. Those who may be candidates will be informed about the study and referred to the physiotherapy department where the treatment orders for these patients will be received and an appointment will be made. This is the start of the recruitment phase.
Those who meet the criteria and agree to participate in the study will be assigned an identification code and will be randomised into the two groups, the intervention group and the conventional treatment group.
Patients who do not meet the inclusion criteria or refuse to participate in the study will receive conventional treatment.
A 6-month pilot study will be conducted to better define patient identification, inclusion criteria, recruitment and adjustment of the intervention if required.
Once the pilot study is completed, the intervention clinical trial will begin. A first analysis of all variables will be performed after the intervention phase of the trial, 6 weeks after inclusion in the study.
An interim analysis will also be performed at 3 months in which the same variables as at 6 weeks will be assessed. This will be the main analysis of the study.
The final analysis will be carried out 6 months after inclusion in the study, and this will conclude the follow-up phase.
- Conditions
- Breast Cancer
- Being tested
- Active Comparator: Group 1. Conventional treatment, Experimental: Group 2. Experimental treatment.
- Keywords
- Exercise, Muscle Weakness, Lymphedema, Fatigue, Depression
- Medical subject headings
- Breast Neoplasms, Motor Activity, Muscle Weakness, Lymphedema, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Group 1. Conventional treatmentOther
Patients will be treated using a physiotherapy programme without digital support. A written document with exercises and recommendations will be given to them on the first day. This booklet will detail the exercises they can do depending on their surgery and the weeks elapsed, as well as the recommendations adapted according to the needs identified in the motivational interview (MI). This is the treatment that is currently being applied in the hospital.
The patient will carry out the treatment at home and will come back after 20 sessions for the corresponding assessment.
Experimental: Group 2. Experimental treatment.Other
A digitally supported physiotherapy programme including:
- Group session: expectations, interests, experiences with regard to their health problem and the consequences on their life, joint exercise and discussion with subsequent debate will be held.
- Exercise session: each week, patients will find different exercise videos on the platform according to the phase of recovery in which each one of them is, having been previously evaluated in the group session.
- Relaxation session: this will be carried out by means of audio that will be posted on the platform and that the patient will be able to perform simultaneously.
- Empowerment session: audio sessions that will deal with those needs that frequently arise after breast surgery in their daily lives, focusing on limiting beliefs (e.g. fear of moving), positive thoughts and information extracted from the motivational interview that should be developed.
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Conventional treatment | Active comparator | Patients will be treated with a physiotherapy programme without digital support. Receives: Other: Active Comparator: Group 1. Conventional treatment |
| Group 2. Experimental treatment. | Experimental | Patients will be treated using a digitally supported physiotherapy programme. Receives: Other: Experimental: Group 2. Experimental treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand Score (DASH)
Global assessment of the functionality of the upper limb,
Measured: 12 weeks
Disabilities of the Arm, Shoulder and Hand Score (DASH)
Global assessment of the functionality of the upper limb,
Measured: 3 months
Secondary outcomes (5)
European organization for research and treatment of cancer quality life questionnaire core 30. (QLQ-C30-B23)
Questionnaire to assess quality of life in cancer patients. Module B23, which is specific to breast cancer, will be used.
Measured: 12 weeks
Range Of Motion (ROM)
Goniometry of joint range
Measured: 12 weeks
Tampa Scale for Kinesiophobia (TSK-11SV)
The TSK is an 11-item self-report measure related to fear of movement and re-injury from movement.
Measured: 12 weeks
Brief Pain Inventory (BPI)
The BPI is a multidimensional pain assessment tool that provides information on pain intensity and its interference with patients' daily activities. It also assesses the description, the location of pain and the level of relief provided by the treatment.
Measured: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Questionnaire to measure levels of anxiety and depression in these people.
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 posted8 Apr 2021
- Study start2 Aug 2021
- Primary completion28 Oct 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1. Conventional treatment. Patients will be treated by means of a physiotherapy programme without digital support. They will be given a written document with exercises and recommendations on the first day. Group 2. Experimental treatment. Patients will be treated with a digitally supported physiotherapy programme.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Belén Romojaro Rodríguez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837248
- Sponsor's protocol ID
- PI-2021-3
- Status last verified
- Feb 2025
- First submitted
- 6 Apr 2021
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pellini F, Granuzzo E, Urbani S, Mirandola S, Caldana M, Lombardi D, Fiorio E, Mandara M, Pollini GP. Male Breast Cancer: Surgical and Genetic Features and a Multidisciplinary Management Strategy. Breast Care (Basel). 2020 Feb;15(1):14-20. doi: 10.1159/000501711. Epub 2019 Sep 13.
PubMed 32231493Hidding JT, Beurskens CH, van der Wees PJ, van Laarhoven HW, Nijhuis-van der Sanden MW. Treatment related impairments in arm and shoulder in patients with breast cancer: a systematic review. PLoS One. 2014 May 9;9(5):e96748. doi: 10.1371/journal.pone.0096748. eCollection 2014.
PubMed 24816774van Egmond MA, van der Schaaf M, Vredeveld T, Vollenbroek-Hutten MMR, van Berge Henegouwen MI, Klinkenbijl JHG, Engelbert RHH. Effectiveness of physiotherapy with telerehabilitation in surgical patients: a systematic review and meta-analysis. Physiotherapy. 2018 Sep;104(3):277-298. doi: 10.1016/j.physio.2018.04.004. Epub 2018 Jun 19.
PubMed 30030037
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Evaluation of the Effects of a Physical Therapy Program With Digital Support in Patients With Breast Cancer Surgery. A Clinical Trial.
- ClinicalTrials.gov ID
- NCT04837248
- Acronym / sponsor ID
- PI-2021-3
- Conditions
- Breast Cancer
- Keywords
- Exercise, Muscle Weakness, Lymphedema, Fatigue, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 8 Apr 2021 (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.
Breast cancer surgery usually results in reduced range of motion of the shoulder joint, weakness of the musculature and altered scapular kinematics during movement. These factors limit activities of daily living, so rehabilitation exercises help to restore function after shoulder surgery.
Women with breast cancer often have a life conditioned by the sequelae or morbidity secondary to the treatment of the disease and, despite the high cure rate, many patients are unable to regain their initial quality of life. Cancer therapies can leave physical, psychological and psychosocial sequelae, which may manifest themselves or persist even years after the end of treatment.
For all these reasons, patients who have undergone cancer treatment need physical rehabilitation as well as psychological and social care to support them in their new stage of life, and to optimise the rehabilitation programme, it is necessary to identify each patient's individual needs,
The digital support proposed in this study enables the development of a physiotherapy programme for patients with breast cancer in a situation of health crisis, which includes providing assistance, information, accompaniment, help and treatment to these patients in a comprehensive way, based on the biopsychosocial model.
Detailed description
DESIGN: Single-centre, assessor-blinded, parallel-group, randomised controlled clinical trial.
METHODS: The study will be carried out at the Ramon y Cajal hospital with 92 patients diagnosed and operated on for breast cancer.
Patients who come to the consultation of the rehabilitation doctors will be assessed, considering the inclusion and exclusion criteria. Those who may be candidates will be informed about the study and referred to the physiotherapy department where the treatment orders for these patients will be received and an appointment will be made. This is the start of the recruitment phase.
Those who meet the criteria and agree to participate in the study will be assigned an identification code and will be randomised into the two groups, the intervention group and the conventional treatment group.
Patients who do not meet the inclusion criteria or refuse to participate in the study will receive conventional treatment.
A 6-month pilot study will be conducted to better define patient identification, inclusion criteria, recruitment and adjustment of the intervention if required.
Once the pilot study is completed, the intervention clinical trial will begin. A first analysis of all variables will be performed after the intervention phase of the trial, 6 weeks after inclusion in the study.
An interim analysis will also be performed at 3 months in which the same variables as at 6 weeks will be assessed. This will be the main analysis of the study.
The final analysis will be carried out 6 months after inclusion in the study, and this will conclude the follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1. Conventional treatment. Patients will be treated by means of a physiotherapy programme without digital support. They will be given a written document with exercises and recommendations on the first day. Group 2. Experimental treatment. Patients will be treated with a digitally supported physiotherapy programme.
| Arm | Type | Receives |
|---|---|---|
| Group 1. Conventional treatment | Active comparator | Other: Active Comparator: Group 1. Conventional treatmentPatients will be treated with a physiotherapy programme without digital support. |
| Group 2. Experimental treatment. | Experimental | Other: Experimental: Group 2. Experimental treatment.Patients will be treated using a digitally supported physiotherapy programme. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of stage I, II or III of Breast cancer treated by surgery.
- Medical authorisation for participation.
- Internet access.
- Basic computer skills.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Breast cancer treated without surgery.
- Patient in severe psychiatric treatment who may present difficulties for participation in the study.
- Stage IV cancer.
- Any other clinical condition or previous therapy that contraindicates one or more of the techniques included in the programme, as the intervention may not be safe for the patient and therefore the person would not be eligible to participate in the study.
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 |
|---|---|---|
| Active Comparator: Group 1. Conventional treatmentPatients will be treated using a physiotherapy programme without digital support. A written document with exercises and recommendations will be given to them on the first day. This booklet will detail the exercises they can do depending on their surgery and the weeks elapsed, as well as the recommendations adapted according to the needs identified in the motivational interview (MI). This is the treatment that is currently being applied in the hospital. The patient will carry out the treatment at home and will come back after 20 sessions for the corresponding assessment. | Other | Group 1. Conventional treatment |
| Experimental: Group 2. Experimental treatment.A digitally supported physiotherapy programme including: * Group session: expectations, interests, experiences with regard to their health problem and the consequences on their life, joint exercise and discussion with subsequent debate will be held. * Exercise session: each week, patients will find different exercise videos on the platform according to the phase of recovery in which each one of them is, having been previously evaluated in the group session. * Relaxation session: this will be carried out by means of audio that will be posted on the platform and that the patient will be able to perform simultaneously. * Empowerment session: audio sessions that will deal with those needs that frequently arise after breast surgery in their daily lives, focusing on limiting beliefs (e.g. fear of moving), positive thoughts and information extracted from the motivational interview that should be developed. | Other | Group 2. Experimental treatment. |
Primary outcome
Disabilities of the Arm, Shoulder and Hand Score (DASH)
Time frame: 12 weeks
Global assessment of the functionality of the upper limb,
Disabilities of the Arm, Shoulder and Hand Score (DASH)
Time frame: 3 months
Global assessment of the functionality of the upper limb,
5 secondary outcomes
European organization for research and treatment of cancer quality life questionnaire core 30. (QLQ-C30-B23)
Time frame: 12 weeks
Range Of Motion (ROM)
Time frame: 12 weeks
Tampa Scale for Kinesiophobia (TSK-11SV)
Time frame: 12 weeks
Brief Pain Inventory (BPI)
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 32231493Pellini F, Granuzzo E, Urbani S, Mirandola S, Caldana M, Lombardi D, Fiorio E, Mandara M, Pollini GP. Male Breast Cancer: Surgical and Genetic Features and a Multidisciplinary Management Strategy. Breast Care (Basel). 2020 Feb;15(1):14-20. doi: 10.1159/000501711. Epub 2019 Sep 13.
- Background: PubMed 24816774Hidding JT, Beurskens CH, van der Wees PJ, van Laarhoven HW, Nijhuis-van der Sanden MW. Treatment related impairments in arm and shoulder in patients with breast cancer: a systematic review. PLoS One. 2014 May 9;9(5):e96748. doi: 10.1371/journal.pone.0096748. eCollection 2014.
- Background: PubMed 30030037van Egmond MA, van der Schaaf M, Vredeveld T, Vollenbroek-Hutten MMR, van Berge Henegouwen MI, Klinkenbijl JHG, Engelbert RHH. Effectiveness of physiotherapy with telerehabilitation in surgical patients: a systematic review and meta-analysis. Physiotherapy. 2018 Sep;104(3):277-298. doi: 10.1016/j.physio.2018.04.004. Epub 2018 Jun 19.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Group 1. Conventional treatment and Experimental: Group 2. Experimental treatment. in people with Breast Cancer, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 12 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: finished, as of the sponsor's last update on 26 Feb 2025. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand Score (DASH) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04837248, which also lists 3 linked publications.
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 26 Feb 2025.