Effects of a Functional Re-education and Environmental Adaptation Programme in Cancer Patients With Associated Respiratory Pathology

NCT06035263 | Unknown

• 1 other identifier: University of Salamanca 2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

the investigators propose an interdisciplinary intervention, carried out by occupational therapists, nurses, physiotherapists and doctors specialised in this type of patient, aimed at improving conventional clinical practice and implementing a programme of functional re-education and environmental adaptation that implements conventional clinical practice, and which the investigators also consider to be an essential intervention in the follow-up of patients with associated respiratory pathology once they are discharged from hospital.

Conditions

Cancer; Dyspnea; Functionality; Quality of Life; Functional Capacity

Keywords

Functional Status; Cancer; Dyspnea; Quality of Life; Occupational therapy

Outcome Measures

Primary Outcomes (1)

• Activities of daily living

  Barthel Index

  Baseline; 1 week (follow up); 2 weeks (final)

Secondary Outcomes (5)

• dyspnoea

  Baseline; 1 week (follow up); 2 weeks (final)

• Health-related quality of life

  Baseline; 1 week (follow up); 2 weeks (final)

• General Pain

  Baseline; 1 week (follow up); 2 weeks (final)

• Physical performance assessment

  Baseline; 1 week (follow up); 2 weeks (final)

• pain/fatigue-related fear of movement

  Baseline; 1 week (follow up); 2 weeks (final)

Study Arms (2)

FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME

EXPERIMENTAL

prescription of reeducation in activities of daily living and the prescription of assistive devices and environmental adaptations, for one month from the first baseline assessment at the time of hospital discharge.

Other: FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME

Health education programme:

ACTIVE COMPARATOR

instructions and recommendations for maintaining an active and healthy life will be given as part of a health education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow, as well as the importance of nutrition and hydration in a healthy lifestyle. They will receive the dossier of instructions and recommendations of the health education programme, as in the experimental group.

Other: Health education programme:

Interventions

FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME OTHER

the prescription of reeducation in activities of daily living and the prescription of assistive devices and environmental adaptations, for one month from the first baseline assessment at the time of hospital discharge.

FUNCTIONAL REEDUCATION AND ENVIRONMENTAL ADAPTATION PROGRAMME

Health education programme: OTHER

instructions and recommendations for maintaining an active and healthy life will be given as part of a health education programme. These will focus on the benefits of an active lifestyle and general guidelines to follow, as well as the importance of nutrition and hydration in a healthy lifestyle. They will receive the dossier of instructions and recommendations of the health education programme, as in the experimental group.

Health education programme:

Eligibility Criteria

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

You may qualify if:

• To have, among the reasons for admission, an anatomopathological diagnosis of newly diagnosed or relapsed oncological disease.
• To be admitted to the Oncology Department of the University Hospital of Salamanca.
• Moderate to severe dependency: Barthel Index score between 20 and 55 points.
• Sign an informed consent form authorising their voluntary participation in the study.

You may not qualify if:

• Cognitive impairment as assessed by the Mini-Mental State Examination (MMSE) of less than 24 points.
• Haemoglobin level of less than 10g/dl.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Eduardo Jose Fernandez Rodriguez

Salamanca, Castille and León, 37002, Spain

Location

Related Publications (1)

• Fernandez-Rodriguez EJ, Rihuete-Galve MI, Garcia-Martin A, Sanchez-Gomez C, Barbero-Iglesias FJ, Mendez-Sanchez R, Puente-Gonzalez AS, Saez-Gutierrez S, Fonseca-Sanchez E, Cruz-Hernandez JJ. Impact of functional re-education and environmental adaptation in cancer patients with respiratory pathology: Study protocol. PLoS One. 2025 Jan 9;20(1):e0313207. doi: 10.1371/journal.pone.0313207. eCollection 2025.

  PMID: 39787149 DERIVED

MeSH Terms

Conditions

Neoplasms; Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will also be blinded and will not know which group they have been allocated to and therefore which intervention they will receive. In order to minimise any contamination between groups, the assessment process will be carried out by external research staff who will perform the measurements and who have been previously trained and educated to avoid subjective bias in the process, as they will be unaware of the intervention group to which each elderly centre is assigned, so the clinical trial will have a masking of the blinded assessment by third parties.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 13, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-11

Locations

ES (1)