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

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ClinicalTrials.gov Identifier: NCT04837248
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Ana Belén Romojaro Rodríguez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: Active Comparator: Group 1. Conventional treatment Other: Experimental: Group 2. Experimental treatment. Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
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.
Actual Study Start Date : August 2, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1. Conventional treatment
Patients will be treated with a physiotherapy programme without digital support.
 Other: Active Comparator: Group 1. Conventional treatment

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.
Patients will be treated using a digitally supported physiotherapy programme.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Disabilities of the Arm, Shoulder and Hand Score (DASH) [ Time Frame: 12 weeks ]
    Global assessment of the functionality of the upper limb,

  2. Disabilities of the Arm, Shoulder and Hand Score (DASH) [ Time Frame: 3 months ]
    Global assessment of the functionality of the upper limb,


Secondary Outcome Measures :
  1. European organization for research and treatment of cancer quality life questionnaire core 30. (QLQ-C30-B23) [ Time Frame: 12 weeks ]
    Questionnaire to assess quality of life in cancer patients. Module B23, which is specific to breast cancer, will be used.

  2. Range Of Motion (ROM) [ Time Frame: 12 weeks ]
    Goniometry of joint range

  3. Tampa Scale for Kinesiophobia (TSK-11SV) [ Time Frame: 12 weeks ]
    The TSK is an 11-item self-report measure related to fear of movement and re-injury from movement.

  4. Brief Pain Inventory (BPI) [ Time Frame: 12 weeks ]
    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.

  5. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 weeks ]
    Questionnaire to measure levels of anxiety and depression in these people.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837248


Contacts
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Contact: Ana Belén Romojaro Rodriguez, PT. MSc 0034913368250 ana.romojaro@gmail.com
Contact: Itziar Abechuco, Pharmacy 0034913368825 itziar.pablo@salud.madrid.org

Locations
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Spain
Fundacion Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28834
Contact: Ana Belen Romojaro Rodriguez, PT. MSc    0034 666062413    ana.romojaro@gmail.com   
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
More Information
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Publications:

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Responsible Party: Ana Belén Romojaro Rodríguez, Physiotherapist, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT04837248    
Other Study ID Numbers: PI-2021-3
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Belén Romojaro Rodríguez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
Exercise
Muscle Weakness
Lymphedema
Fatigue
Depression
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases