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

NCT04837248 | Completed

• 1 other identifier: PI-2021-3
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Exercise; Muscle Weakness; Lymphedema; Fatigue; Depression

Outcome Measures

Primary Outcomes (2)

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

  Global assessment of the functionality of the upper limb,

  12 weeks

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

  Global assessment of the functionality of the upper limb,

  3 months

Secondary Outcomes (5)

• European organization for research and treatment of cancer quality life questionnaire core 30. (QLQ-C30-B23)

  12 weeks

• Range Of Motion (ROM)

  12 weeks

• Tampa Scale for Kinesiophobia (TSK-11SV)

  12 weeks

• Brief Pain Inventory (BPI)

  12 weeks

• Hospital Anxiety and Depression Scale (HADS)

  12 weeks

Study Arms (2)

Group 1. Conventional treatment

ACTIVE COMPARATOR

Patients will be treated with a physiotherapy programme without digital support.

Other: Active Comparator: Group 1. Conventional treatment

Group 2. Experimental treatment.

EXPERIMENTAL

Patients will be treated using a digitally supported physiotherapy programme.

Other: Experimental: Group 2. Experimental treatment.

Interventions

Active Comparator: Group 1. Conventional treatment OTHER

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.

Group 1. Conventional treatment

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.

Group 2. Experimental treatment.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Fundacion Hospital Ramón y Cajal

Madrid, 28834, Spain

Location

Related Publications (3)

• 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.

  PMID: 32231493 BACKGROUND

• 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.

  PMID: 24816774 BACKGROUND

• 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.

  PMID: 30030037 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Muscle Weakness; Lymphedema; Fatigue; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will assess patients at baseline, 6 weeks, 12 weeks, and 6 months and will not know which arm of the study each patient belongs to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: August 2, 2021
• Primary Completion: October 28, 2024
• Study Completion: December 30, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)