CompletedNot Applicable

Design and Evaluation of the Effects of a Physical Therapy Program With Digital Support in Patients With Breast Cancer

Spain92 participantsStarted 2021-08-02

Plain-language 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. 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disabilities of the Arm, Shoulder and Hand Score (DASH)

Timeframe: 12 weeks

Disabilities of the Arm, Shoulder and Hand Score (DASH)

Timeframe: 3 months

Trial details

NCT IDNCT04837248

SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-28

View on ClinicalTrials.gov More Breast Cancer trials