Clinical trial NCT04761289: 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.
Official title: 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. Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Cancer-Related Syndrome
Fatigue
Keywords: Cancer
Rehabilitation
Occupational therapy
Fatigue
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* 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).

Exclusion criteria:

* 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.

Primary outcomes:
measure: Activities of Daily Living (ADL)
timeFrame: BASAL VISIT: It will be carried out at the time prior to the discharge of hospitalization patients.
Secondary outcomes:
measure: Cancer related fatigue
timeFrame: 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.
measure: Attention and executive functions
timeFrame: 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.
measure: Health-related quality of life (HRQL)
timeFrame: 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.
measure: Cancer pain
timeFrame: 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.
measure: Functional Capacity
timeFrame: 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.
measure: Kinesiophobia
timeFrame: 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.
measure: Weight
timeFrame: 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.
measure: Height
timeFrame: 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.
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad de Salamanca
Study officials:
References:
citation: 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.