Effects of a Multimodal Physical Exercise and Functional Rehabilitation Program on Fatigue, Pain, Functional Capacity and Quality of Life in Cancer Patients With Tumor Asthenia.

NCT04761289 | Completed DMC

• 1 other identifier: 245381
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Tumor asthenia is the most common symptom associated with cancer and its treatment. Although the estimated prevalence varies between 60-90%, and it is considered the longest-lasting symptom in cancer patients, having the greatest impact on quality of life parameters, it is a problem that is still undervalued in general by health professionals . It has been observed that individuals with this process find it difficult to normalize their daily life, either due to a deterioration in their clinical condition or due to a problem in the generalization of what they have learned during their hospital stay. That is why we plan to carry out a clinical trial, to evaluate the effect of a controlled patient follow-up program, and thus be able to address these difficulties in the most optimal way. A randomized clinical trial of two parallel groups will be carried out, belonging to the oncology service of the University Hospital of Salamanca. 44 participants with tumor asthenia, who are admitted at the time of inclusion, will be selected through a consecutive sampling. After the baseline evaluation, the participants will be randomized into two groups. The subjects of the experimental group will carry out a Functional Rehabilitation Program, with a duration of one month. The main variable will be the evaluation of the basic activities of daily life (Barthel scale). The secondary variables will be oriented to evaluate the change in tumor asthenia, attention and cognitive functions, parameters of quality of life, pain, functional capacity and body composition. The results of this study could be transferred to the clinic, incorporating them into care protocols for cancer patients with tumor asthenia.

Conditions

Cancer; Cancer-Related Syndrome; Fatigue

Keywords

Cancer; Rehabilitation; Occupational therapy; Fatigue

Outcome Measures

Primary Outcomes (1)

• Activities of Daily Living (ADL)

  Barthel index (BI) will be used, whose version has been translated and validated into Spanish (4). The scale assigns a score based on their degree of dependency to perform a series of basic activities, obtaining a score on each item that ranges from 0 to 15 points. The global range can vary between 0 (completely dependent) and 100 points (completely independent).

  BASAL VISIT: It will be carried out at the time prior to the discharge of hospitalization patients.

Secondary Outcomes (8)

• Cancer related fatigue

  FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation.

• Attention and executive functions

  FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation.

• Health-related quality of life (HRQL)

  FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation.

• Cancer pain

  FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation.

• Functional Capacity

  FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation.

Study Arms (2)

Control group. Health education program

ACTIVE COMPARATOR

The participants in this group will undergo the usual clinical practice: compliance and adherence to the prescribed drug treatment will be explained, as well as the established guidelines for individualized health care. A Health Education Program will also be added at discharge, mainly aimed at reinforcing and promoting an active and healthy life.

Other: Multimodal Exercise and Functional Rehabilitation Program

Experimental Group. Multimodal Exercise and Functional Rehabilitation Program

EXPERIMENTAL

1. Prescription of multimodal physical exercise. A supervised and structured home program will be carried out for one month. It will be carried out daily in two short sessions of 15-20 minutes, one in the morning and one in the afternoon. Each session will be structured in a warm-up, a main part and a cool-down and relaxation (14). 2. Reeducation of Activities of Daily Living (ADL). Specific training will be carried out after the evaluation and before the discharge of the patients from the university healthcare complex. It is intended to identify the factors that are interfering with the performance of activities of daily living. The intervention will consist of three parts: Direct intervention on Activities of Daily Living (ADL), carried out in situ in the hospitalization and generalizable to their daily environment; teaching in Energy Saving Techniques (APR). 3. Prescription of support products and adaptations of the environment.

Other: Multimodal Exercise and Functional Rehabilitation Program

Interventions

Multimodal Exercise and Functional Rehabilitation Program OTHER

1. Prescription of multimodal physical exercise. 2. Reeducation of Activities of Daily Living (ADL). 3. Prescription of support products and adaptations of the environment.

Control group. Health education program; Experimental Group. Multimodal Exercise and Functional Rehabilitation Program

Eligibility Criteria

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

You may qualify if:

• Having among the reasons for admission a pathological diagnosis of newly diagnosed or relapsed oncological disease.
• Being admitted to the Oncology Service of the Salamanca University Hospital.
• Barthel index score between 15 and 55 points.
• Level of tumor asthenia greater than or equal to 4 on the EVA scale for tumor asthenia.
• Sign an informed consent in which they authorize their voluntary participation in the study (Annex II).

You may not qualify if:

• Present cognitive impairment assessed with the Mini-mental State Examination (MMSE) less than 24 points.
• Present hemoglobin levels below 10g / dl.
• Withdrawal criteria:
• Exitus of the patient.
• Progression of the disease leading to a terminal state.
• Hospitalization of the patient at the time of home monitoring.
• Do not carry out Final Assessment.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Universidad de Salamanca

Salamanca, 37001, Spain

Location

Related Publications (1)

• Fernandez-Rodriguez EJ, Gonzalez-Sanchez J, Puente-Gonzalez AS, Recio-Rodriguez JI, Sanchez-Gomez C, Mendez-Sanchez R, Cruz-Hernandez JJ, Rihuete-Galve MI. Multimodal physical exercise and functional rehabilitation program in oncological patients with asthenia. study protocol. BMC Nurs. 2021 Oct 22;20(1):207. doi: 10.1186/s12912-021-00734-9.

  PMID: 34686180 DERIVED

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 18, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)