2.5. Variables and Measurement Instruments
Fatigue, fatigue, Cancer
CANCER
Barthel Index (BI) [Fourth version of the Functional Evaluation of Cancer Therapy-Anemia (FACT-An) [EuroQoL 5-D Questionnaire (EQ-5D) [A visual analogue scale (VAS) [Short Physical Performance Battery (SPPB) [The Tampa Scale of Kinesiophobia–Fatigue (TSK-F) [All measurements taken were recorded on a data collection sheet for each patient and then recorded in a database designed for this study.Interventions: The intervention was carried out by an interdisciplinary team specialized in oncology patients. The team consisted of physiotherapists, occupational therapists, nurses, and oncology doctors. Participants in both study groups received pharmacological treatment and specific care, as well as guidelines adapted to their specific health needs. Prior to hospital discharge, all participants received a health education program and materials promoting an active and healthy lifestyle as part of the intervention. This program consisted of an informative talk and a guideline with written indications.The experimental group, in addition to the conventional care, participated in an intervention implemented with a month-long multimodal program of physical exercise and functional rehabilitation at home. This program consisted of:1. Multimodal physical exercise program:A supervised and structured multimodal physical exercise program was carried out at home for one month. Two short sessions of 15–20 min per day were performed, one in the morning and one in the afternoon. The sessions followed the 2010 American College of Sports Medicine (ACSM) recommendations for the structure of each session [The sessions were mainly based on a combination of aerobic and resistance training. The warm-up consisted of aerobic exercises designed to promote joint mobility and muscle activation. The cool-down consisted of aerobic training with mild muscle stretching and relaxation exercises. The main phase of the program combined aerobic and balance exercises with moderate-load resistance exercises. These were targeted to upper and lower quadrant muscle groups with 2 sets of 4–8 repetitions. In the exercise program, mainly in the resistance and balance exercises, the dose and load were individually adapted according to the initial and intermediate assessment and, followed by a progression in difficulty and load, were coordinated in a global workout encompassing the major muscle groups at least 3–4 times during the week.In the exercise program, mainly in the resistance and balance exercises, the dose and load were individually adapted according to the initial and intermediate assessment and followed a progression in difficulty and load, maintaining a moderate intensity in their performance according to a perception of moderate exertion on the Borg scale (score 4–6/10). The program was supervised by an external researcher contracted for this task in a face-to-face clinical evaluation.2. Functional rehabilitation program:This program consisted of re-education of activities of daily living. Before hospital discharge, specific training was carried out to identify factors that hindered or prevented the performance of ADLs: (1) direct intervention on ADLs performed in the hospital that was generalized to the patient’s daily environment; (2) simplifying activities and teaching energy-saving techniques (EST); and (3) sleep hygiene counseling according to specific NCCN guidelines on cancer-related fatigue [3. Environmental adaptations and the need for assistive products: In addition, prior to discharge, we assessed whether assistive products could be prescribed to support personal autonomy and identified potential barriers in the home. This was achieved by visiting the patient’s own home and observing first-hand the difficulties that restrict normal daily activities.Work plan and visits: As shown in the flowchart in Baseline visit: The initial evaluation was performed before patient discharge, checking the inclusion and exclusion criteria at baseline. At this visit, sociodemographic data, medical history, comorbidities, and pharmacological treatments of the patients were recorded, and as in the rest of the visits, all the outcome variables of the study were collected. Randomization and assignment to the study groups was performed once the baseline visit was completed, and the necessary indications were given to the patients in each of the groups.Intermediate and final visits: At these visits, all the outcome variables collected at the baseline visit were recorded again. The follow-up visits, at 15 days and 1 month after the start of the study, were carried out in the Clinical Teaching Assistance Unit of the Faculty of Psychology at the University of Salamanca.Data analysis: The study data were collected in a database using a unique identification code for each study participant. This database did not contain personal or contact information for any of the participants. Baseline characteristics of the study population were expressed as mean ± standard deviation (SD) for quantitative variables and as frequency distribution for categorical variables.Baseline data were analyzed to calculate differences between groups using an independent-samples t-test for quantitative variables, and the chi-squared test for qualitative variables.The statistical analysis was carried out on an intention-to-treat basis with two-way repeated measures ANOVA. Unadjusted and baseline-adjusted models were used in cases in which the baseline value had a statistically significant difference in the baseline assessment between groups (FACT, FACT other concerns, SPPB, SPPB gait speed). The presence or absence of sphericity was considered and Greenhouse–Geisser correction was performed when necessary. Hypothesis testing established an α of 0.05. Data were analyzed with the SPSS Statistics version 26.0 software (IBM Corp, Armonk, NY, USA).