Study of an Integral Respiratory Rehabilitation Program in Oncological Patient With Disney

NCT04186754 | Completed DMC

• 1 other identifier: 245380
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Oncological patients presenting with respiratory problems will benefit both at a functional level and at a level of quality of life from the inclusion of a program of integral respiratory rehabilitation from the perspective of nursing and occupational therapy at the time of admission hospital for an exacerbation of his respiratory symptoms. Main objective: to verify the effectiveness of a comprehensive respiratory rehabilitation program carried out from the perspective of an interdisciplinary team made up of nurses, occupational therapists and doctors in the improvement of the respiratory problem referred to oncological disease. Design: experimental, randomized, stratified, longitudinal prospective study through a parallel scheme of fixed assignment with experimental group and control group.

Conditions

Occupational Therapy; Cancer; Dyspnea; Rehabilitation

Keywords

Occupational Therapy; Cancer; Dyspnea

Outcome Measures

Primary Outcomes (1)

• Dyspnoea

  MRC scale

  Up to 3 years

Secondary Outcomes (1)

• Activities of Daily Living

  Up to 3 years

Study Arms (2)

Comprehensive functional care plan

EXPERIMENTAL

The intervention will be carried out thanks to the "reeducation to the effort" carried out in the individuals, which will have the following interventions: The treatment should be carried out INDIVIDUALIZED, in the hospital room or in a conditioned room, in sessions of approximately 30 minutes and on a daily basis. Carried out by professionals in the disciplines of nursing and occupational therapy.

Procedure: Comprehensive functional care plan

Traditional intervention without rehabilitation

ACTIVE COMPARATOR

* Nursing care. * Medical care. * Spiritual attention.

Procedure: Traditional intervention without rehabilitation

Interventions

Comprehensive functional care plan PROCEDURE

The treatment should be carried out INDIVIDUALIZED, in the hospital room or in a conditioned room, in sessions of approximately 30 minutes and on a daily basis. Carried out by professionals in the disciplines of nursing and occupational therapy.

Comprehensive functional care plan

Traditional intervention without rehabilitation PROCEDURE

Clinical control by nursing professionals and exclusively pharmacological treatment

Traditional intervention without rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have an anatomopathological diagnosis of cancer disease among the reasons for admission.
• Present at least some level 2 or moderate dyspnea parameters on the MRC scale.
• Be admitted to the University Hospital of Salamanca.
• Sign an informed consent authorizing their voluntary participation in the study.

You may not qualify if:

• Present a diagnosis of bone metastases.
• Not having an adequate cognitive state to understand and carry out the orders provided.
• Carry out a number of rehabilitation sessions of less than 5.
• Present hemoglobin levels below 10g / dl.
• To be an active smoker today.
• Present pleural effusion.
• Present febrile neutropenia.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Eduardo José Fernández

Salamanca, 37900, Spain

Location

Related Publications (1)

• Fernandez-Rodriguez EJ, Sanchez-Gomez C, Fonseca-Sanchez E, Cruz-Hernandez JJ, Rihuete-Galve MI. Impact of a multimodal effort re-education programme on functionality, physical performance, and functional capacity in cancer patients with dyspnoea: a randomised experimental study. Support Care Cancer. 2024 Sep 6;32(10):639. doi: 10.1007/s00520-024-08852-1.

  PMID: 39237780 DERIVED

MeSH Terms

Conditions

Neoplasms; Dyspnea

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Eduardo IP Fernández, OT

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: December 5, 2019
• Study Start: September 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: We do not establish a specific period of time, access will be permanent.
• Access Criteria: Researcher upon invitation by mail

Locations

ES (1)