Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial.

BACKGROUND: Patients with advanced cancer, receiving at-home palliative care, are subject to numerous symptoms that are changeable and often require attention, a stressful situation that also impacts on the family caregiver. It has been suggested that music therapy may benefit both the patient and the caregiver. We propose a study to analyse the efficacy and cost utility of a music intervention programme, applied as complementary therapy, for cancer patients in palliative care and for their at-home caregivers, compared to usual treatment. METHOD: A randomised, double-blind, multicentre clinical trial will be performed in cancer patients in at-home palliative care and their family caregivers. The study population will include two samples of 40 patients and two samples of 41 caregivers. Participants will be randomly assigned either to the intervention group or to the control group. The intervention group will receive a seven-day programme including music sessions, while the control group will receive seven sessions of (spoken word) therapeutic education. In this study, the primary outcome measure is the assessment of patients' symptoms, according to the Edmonton Symptom Assessment System, and of the overload experienced by family caregivers, measured by the Caregiver Strain Index. The secondary outcomes considered will be the participants' health-related quality of life, their satisfaction with the intervention, and an economic valuation. DISCUSSION: This study is expected to enhance our understanding of the efficacy and cost-utility of music therapy for cancer patients in palliative care and for their family caregivers. The results of this project are expected to be applicable and transferrable to usual clinical practice for patients in home palliative care and for their caregivers. The approach described can be incorporated as an additional therapeutic resource within comprehensive palliative care. To our knowledge, no previous high quality studies, based on a double-blind clinical trial, have been undertaken to evaluate the cost-effectiveness of music therapy. The cost-effectiveness of the project will provide information to support decision making, thereby improving the management of health resources and their use within the health system. TRIAL REGISTRATION: The COMTHECARE study is registered at Clinical Trials.gov, NCT04052074. Registered 9 August, 2019.

Development and Psychometric Validation of an Instrument to Identify Barriers to Self-Care Among Spanish Patients With Type 2 Diabetes on the Basis of Theory of Planned Behavior.

BACKGROUND: Several instruments are available to evaluate barriers to self-care in people with type 2 diabetes, but with significant psychometric weaknesses and poor theoretical background. OBJECTIVES: To develop and psychometrically validate a questionnaire to identify barriers to self-care in this population on the basis of the theory of planned behavior. METHODS: The study was carried out in 15 primary healthcare centers belonging to the Public Health Care System in Andalusia (Spain). After content validity was confirmed, an initial pilot study was undertaken (n = 54) and the model was evaluated in 2 samples of 205 subjects each to test its configural and metric invariance by confirmatory factor analysis. Internal consistency, test-retest reliability, criterion validity, and interpretability were carried out following COSMIN standards. RESULTS: A 4-factor instrument (intention, subjective norms, perceived control, and attitudes) with 15 items was obtained with a good fit: goodness-of-fit index = 0.92, comparative fit index = 0.93, and root mean square error of approximation = 0.043 (90% confidence interval 0.034-0.052). Cronbach α was 0.78, and test-retest reliability was adequate (intraclass correlation coefficient 0.73; P < .0001). The instrument revealed an adequate criterion validity depending on the treatment complexity and level of metabolic control. Thus, participants with poor self-care scores were more likely to suffer from diabetes-related complications (odds ratio 1.91; 95% confidence interval 1.15-3.1). CONCLUSIONS: A theory-driven instrument is suitable for its use with Spanish people with type 2 diabetes to assess their self-care needs and make tailored recommendations for lifestyle modifications on the basis of their behavioral determinants.

Effect of Self-Chosen Music in Alleviating the Burden on Family Caregivers of Patients with Advanced Cancer: A Randomised Controlled Trial.

The experience of caregiver burden among family members of patients with advanced cancer is a common problem. The aim of this study was to determine whether the burden may be alleviated by means of a therapeutic approach based on self-chosen music. This randomised controlled trial (ClinicalTrials.gov, NCT04052074. Registered 9 August 2019) included 82 family caregivers of patients receiving home palliative care for advanced cancer. The intervention group (n = 41) listened to pre-recorded, self-chosen music for 30 min/day for seven consecutive days, while the control group (n = 41) listened to a recording of basic therapeutic education at the same frequency. The degree of burden was assessed by the Caregiver Strain Index (CSI), calculated before and after the seven-day intervention. According to this measure, caregiver burden fell significantly in the intervention group (CSI change: -0.56, SD 2.16) but increased in the control group (CSI change: +0.68, SD 1.47), with a significant group x moment interaction F(1, 80) = 9.30, p = 0.003, η2p = 0.11. These results suggest that, in the short term at least, the use of therapy based on self-chosen music alleviates the burden on family caregivers of palliative cancer patients. Moreover, this therapy is easy to administer at home and does not present any problems in practice.

Risk and Protective Factors for Frailty in Pre-Frail and Frail Older Adults.

This study aims to evaluate the differences in body composition, physical function, and physical activity between pre-frail/frail older adults and to detect risk and protective factors against frailty and physical frailty. Fried's criteria for frailty and physical frailty using the short-performance physical battery (SPPB) were measured in 179 older participants (75.3 ± 6.4 years old). Body weight, height, and waist, arm, and leg circumferences were obtained as body composition variables. Daily accelerometer outcomes (physical activity and inactivity) were obtained. Pre-frail participants showed overall better physical function and spent more time in physical activity and less time in long inactivity periods than frail participants (p < 0.05). Risk frailty factors were higher waist perimeter (Odds Ratio [OR]: 1.032, 95%CI: 1.003-1.062), low leg performance (OR: 1.025, 95%CI: 1.008-1.043), and inactivity periods longer than 30 min (OR:1.002, 95%CI: 1.000-1.005). Protective factors were standing balance (OR:0.908, 95%CI: 0.831-0.992) and SPPB score (OR: 0.908, 95%CI: 0.831-0.992) for frailty, handgrip strength (OR: 0.902, 95%CI: 0.844-0.964) for physical frailty, and light (OR: 0.986, 95%CI: 0.976-0.996) and moderate-to-vigorous (OR: 0.983, 95%CI: 0.972-0.996) physical activity for both. Our findings suggest that handgrip strength, balance, and physical activity are protective frailty factors and can be monitored in pre-frail older adults. Moreover, poor lower body performance and long inactivity periods are frailty risk factors, which highlights their importance in frailty assessment.

Effects of Music on the Quality of Life of Family Caregivers of Terminal Cancer Patients: A Randomised Controlled Trial.

The aim of this study was to investigate the effects of listening to self-chosen music on the quality of life of family caregivers of cancer patients receiving palliative home care. A total of 82 family caregivers were assigned either to the intervention group (n = 41) or to the control group (n = 41) in this double-blind, multicentre, randomised controlled clinical trial. The recruitment period was between July 2020 and September 2021. The intervention group received individualised pre-recorded music in daily 30 min sessions for 7 consecutive days. The control group was given a recorded repetition of the basic therapeutic training education also in 30 min sessions for 7 consecutive days. The primary endpoint assessed was the caregivers' quality of life (Quality of Life Family Version and European Quality of Life visual analogue scale) before and after the intervention. The secondary endpoint was their perceived satisfaction with the intervention (Client Satisfaction Questionnaire). The music intervention was successful, producing a tangible improvement in the caregivers' quality of life (p < 0.01) and satisfaction with the care provided (p = 0.002). The intervention was not only effective but produced no adverse effects. This study encourages the use of self-chosen music as a complementary intervention in nursing care for family caregivers of palliative cancer patients.

Cancer Patients' Satisfaction with In-Home Palliative Care and Its Impact on Disease Symptoms.

The aim of the study was to determine whether the satisfaction of cancer patients with in-home palliative care is associated with the impact of disease symptoms and with self-perceived quality of life. This was a cross-sectional descriptive study, conducted in the primary health care sector in six clinical management units, where 72 patients were recruited over a period of six months. The severity of symptoms was determined by the Edmonton Symptom Assessment System (ESAS). Quality of life was evaluated with the EORTC QLQ-C30 (version 3) questionnaire, and patients' satisfaction with the care received was evaluated by the Client Satisfaction Questionnaire (CSQ-8). The patients' satisfaction with the health care received was represented by an average score of 6, on a scale of 1-10; thus, there is room for improvement in patient satisfaction. Moreover, it was found that more intense symptoms and lower quality of life are associated with lower satisfaction with health care received (p = 0.001). Similarly, when symptoms are more severe, the quality of life is lower (p < 0.001). The identification of fatigue, reduced well-being, pain, drowsiness, and depression as the symptoms experienced with the highest intensity by our patients provides valuable information for health care providers in developing individualized symptom management plans for patients with advanced cancer.

Associations Between Physical Activity and Inactivity Levels on Physical Function and Sleep Parameters of Older Adults With Frailty Phenotype.

This study investigated the relationship between physical activity, inactivity, physical function, and sleep in older adults with a frailty phenotype. A total of 184 pre-frail/frail older adults were included. Physical activity, inactive behavior, and sleep parameters were assessed using a wrist-worn accelerometer. Participants were categorized into four groups based on their levels of inactivity and physical activity. The results showed that individuals with lower levels of inactivity had better lower body mean velocity and sleep regularity than those with higher levels of inactivity. Physically active older adults exhibited faster gait speed and performed better in lower body strength tests than physically inactive participants. Further analysis revealed that specific combinations of inactivity and physical activity were associated with varying levels of physical function. The findings highlight the importance of physical activity and the negative impact of inactivity on physical function and sleep in older adults with a frailty phenotype.