Clinical trial NCT04837248: Design and Evaluation of the Effects of a Physical Therapy Program With Digital Support in Patients With Breast Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Exercise
Muscle Weakness
Lymphedema
Fatigue
Depression
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand Score (DASH)
timeFrame: 12 weeks
measure: Disabilities of the Arm, Shoulder and Hand Score (DASH)
timeFrame: 3 months
Secondary outcomes:
measure: European organization for research and treatment of cancer quality life questionnaire core 30. (QLQ-C30-B23)
timeFrame: 12 weeks
measure: Range Of Motion (ROM)
timeFrame: 12 weeks
measure: Tampa Scale for Kinesiophobia (TSK-11SV)
timeFrame: 12 weeks
measure: Brief Pain Inventory (BPI)
timeFrame: 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Hospital Ramón y Cajal
Study officials:
References:
citation: 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.
citation: Hidding 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.
citation: van 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.