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COMTHECARE
Sponsor study identifier
interventional
160
1 country
1
Study Start
September 20, 2019
Actual (reported)Primary Completion
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Introduction: There is an increase on cancer prevalence and, consequently, a higher number of people that require palliative care, making an influence on the family and the main carer. Objectives:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 14, 2019
Actual (reported)August 9, 2019
Actual (reported)September 20, 2019
Actual (reported)July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Evaluation of the change of symptoms (at the beginning and at 7 days) using The Edmonton Symptom Evaluation System (ESAS)
This scale evaluates the average intensity for several symptoms (pain, anxiety, depression, mood and insomnia) in a specific length of time (24 hours, 48 hours, a week) dependant on the patient's condition. The patient will choose the number that better adjust to the intensity of each symptom.
Preintervention/Postintervention (0 and 7 days)
Evaluation of the change in health-related quality of life (at the beginning and at 7 days) through The EORTC. QLQ-30 (The Quality of Life of Cancer Patients).Version 3
Questionnaire to assess the quality of life of cancer palliative care patients, constituted by 30 items. Items from 1 to 28 correspond to mixed categoric scales from 1 to 4 referring to functional status, physical and emotional symptoms, and the influence of these in the working, social and familial life of the patient. Items 29 and 30 are for the patient to evaluate its general health and quality of life with a 0 to 7 mark.
Preintervention/Postintervention ( 0 and 7 days)
Listening to pre-recorded and selected music preferred by the patient, half an hour for 7 days.
Basic therapeutic education repetition performed to all patients through earphones, half, an hour for 7 days.
Listening to pre-recorded and selected music preferred by the carer, half an hour for 7 days.
We are aiming to use music therapy, with pre-recorded favoured music, as a complementary treatment in oncological patients in palliative care, as well as on the carer. It will be performed using mp3 players or mobile phones.
Basic therapeutic education repetition performed to all caregivers and oncological patients in palliative care, through earphones
Inmaculada Valero Cantero
Málaga, 29014, Spain
Williams AL, McCorkle R. Cancer family caregivers during the palliative, hospice, and bereavement phases: a review of the descriptive psychosocial literature. Palliat Support Care. 2011 Sep;9(3):315-25. doi: 10.1017/S1478951511000265.
Kordovan S, Preissler P, Kamphausen A, Bokemeyer C, Oechsle K. Prospective Study on Music Therapy in Terminally Ill Cancer Patients during Specialized Inpatient Palliative Care. J Palliat Med. 2016 Apr;19(4):394-9. doi: 10.1089/jpm.2015.0384. Epub 2016 Feb 19.
Inmaculada Valero Cantero, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
Milagrosa Espinar Toledo, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
Yolanda Carrión Velasco, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
Pilar Castro López, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
First Submitted
July 14, 2019
First Posted
August 9, 2019
Study Start
September 20, 2019
Actual (reported)Primary Completion
July 2021
Estimated (date passed)Evaluation of the change in the caregiver's effort index (at the beginning and at 7 days) through The Caregiver Strain Index Questionnaire (CSI)
Aimed to be answered by the caregiver of dependent people, containing 13 items with True/False answer. Every positive answer scores for 1. If the total is higher or equal to 7 it indicates a high level of strain. Being validated in Spanish, this is the scale used to evaluate the emotional and physical situation of the caregiver regarding their need to take care of a person in palliative care.
Preintervention/Postintervention ( 0 and 7 days)
Client Satisfaction Questionnaire (CSQ-8)
8 questions answered through a Likert-type scale of 4 points and self-administered, with specific points to each item. The categories would be as follows: quality of the service, type of services, results and general satisfaction. It will include 3 open questions where the subjects answer what they liked most from the treatment, what they liked less, and what they would change. This tool has been proved to determine patient´s satisfaction with high reliability and coherence, being validated in the 8 items versions for Spanish speakers.
Postintervention (7 days)
Evaluation of the change in the quality of self-perceived sleep (at the beginning and at 7 days) through The Pittsburgh Sleep Quality Index (PSQI)
Validated into Spanish. It values the sleep quality perceived by the subject. 7 different scores are obtained from the result, granting information for several components of the sleep quality: subjective quality, sleep latency, sleep duration, sleep efficiency, sleep perturbances (frequency of coughs, snores, heat, cold), sleeping pills intake, diurnal dysfunction (faculty to fall asleep through an activity because of tiredness). The sum of the scores in each component will be included into a Total Score (TS) from 0 to 21. According to Buysse and Cols, a TS of 5 will be the cutting point between a good and a bad sleep quality, less than 5 will show the presence of good sleep quality.
Preintervention/Postintervention ( 0 and 7 days)
Evaluation of the change in total sleep time and rest time (nighttime sleep and daytime rest / naps) by accelerometer (at the beginning and at 7 days)
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
Preintervention/Postintervention (0 and 7 days)
Evaluation of the change in sleep interruption (number of awakenings and wakefulness after the onset of sleep) by accelerometer (at the beginning and at 7 days)
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
Preintervention/Postintervention ( 0 and 7 days)
Evaluation of the change in sleep efficiency (percentage of time in bed sleeping) (at the beginning and at 7 days) by accelerometer
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12.
Preintervention/Postintervention ( 0 and 7 days)
Evaluation of the change in the levels of intensity of daily physical activity (at the beginning and at 7 days) by accelerometer
The accelerometer triaxial: (GeneActiv, Activinsight Ltd, Kimbolton, Cambs, UK, http://www.geneactiv.org/). The data processing is done with an open source package in R, GGIR version 1.5-12. When the EPOCHS (5-second sections) have been calculated, periods of different intensity levels are sought (both sedentary lifestyle maintained and intense activities maintained continuously for most of a period of time). With them, variables are created that indicate both sedentary lifestyle and physical activity.
Preintervention/Postintervention ( 0 and 7 days)
Evaluation of the change in daytime sleepiness (at the beginning and at 7 days) through the Epworth Sleepiness Scale (ESS)
Self-administered scale to measure diurnal sleepiness with 8 questions, scoring from 0 to 3 for a maximum score of 24. This scale is validated in Spanish.
Preintervention/Postintervention ( 0 and 7 days)
Evaluation of the change in the quality of life of the caregiver (at the beginning and at 7 days) through The Quality of Life Family Version (QOL). Dr
It is an instrument that measures the quality of life of a family member who is caring for a patient in chronic illness, validated to Spanish. It values physical and emotional aspects.
Preintervention/Postintervention ( 0 and 7 days)
Evaluation of the consumption of health resources at the beginning, at 7 days and per month
To calculate the expenditure we will analyse the number of Primary Care consultations (family doctor and family nurse), number of home consultations (family doctor, family nurse and case management nurse), number of consultations to the Emergencies service in Primary Care, number of consultations to the hospital Emergencies, and number of hospital admissions (registering number of days). The time used by medical practitioners in phone calls will be also taken into account, from both the Palliative Care Unit and the case management nurse.
Preintervention/ Postintervention/per month ( 0 and 7 days and one month after the intervention)
Medication consumption evaluation at the beginning, at 7 days and per month
We will value the medication intake related to analgesics, anxiolytics and sleeping pills.
Preintervention/ Postintervention/per month ( 0 and 7 days and one month after the intervention)
Availability of payment
The contingent valuation method will be used to determine the readiness to pay. Patients
Postintervention (7 day)
Sessions compliance. Assessment question
Real time dedicated to the activity, for both control and intervention group, will be asked to patients and caregivers during the home visit.
Postintervention (7 day)
Sociodemographic data from palliative care patients
Preintervention (0 day)
Sociodemographic data from caregivers
Preintervention (0 day)
Basic therapeutic education repetition performed to all carer through earphones, half an hour for 7 days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Keenan A, Keithley JK. Integrative Review: Effects of Music on Cancer Pain in Adults. Oncol Nurs Forum. 2015 Nov;42(6):E368-75. doi: 10.1188/15.ONF.E368-E375.
Qi He Mabel L, Drury VB, Hong PW. The experience and expectations of terminally ill patients receiving music therapy in the palliative setting: a systematic review. JBI Libr Syst Rev. 2010;8(27):1088-1111. doi: 10.11124/01938924-201008270-00001.
Bradt J, Dileo C, Magill L, Teague A. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD006911. doi: 10.1002/14651858.CD006911.pub3.
Gallagher LM, Lagman R, Rybicki L. Outcomes of Music Therapy Interventions on Symptom Management in Palliative Medicine Patients. Am J Hosp Palliat Care. 2018 Feb;35(2):250-257. doi: 10.1177/1049909117696723. Epub 2017 Mar 9.
McConnell T, Scott D, Porter S. Music therapy for end-of-life care: An updated systematic review. Palliat Med. 2016 Oct;30(9):877-83. doi: 10.1177/0269216316635387. Epub 2016 Mar 4.
Porter S, McConnell T, Clarke M, Kirkwood J, Hughes N, Graham-Wisener L, Regan J, McKeown M, McGrillen K, Reid J. A critical realist evaluation of a music therapy intervention in palliative care. BMC Palliat Care. 2017 Dec 8;16(1):70. doi: 10.1186/s12904-017-0253-5.
Gallagher LM, Lagman R, Bates D, Edsall M, Eden P, Janaitis J, Rybicki L. Perceptions of family members of palliative medicine and hospice patients who experienced music therapy. Support Care Cancer. 2017 Jun;25(6):1769-1778. doi: 10.1007/s00520-017-3578-y. Epub 2017 Jan 19.
Northouse LL, Mood DW, Schafenacker A, Kalemkerian G, Zalupski M, LoRusso P, Hayes DF, Hussain M, Ruckdeschel J, Fendrick AM, Trask PC, Ronis DL, Kershaw T. Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. Psychooncology. 2013 Mar;22(3):555-63. doi: 10.1002/pon.3036. Epub 2012 Jan 31.
Sales CA, da Silva VA, Pilger C, Marcon SS. [Music in human terminality: the family members' conceptions]. Rev Esc Enferm USP. 2011 Mar;45(1):138-45. doi: 10.1590/s0080-62342011000100019. Portuguese.
Ullrich A, Ascherfeld L, Marx G, Bokemeyer C, Bergelt C, Oechsle K. Quality of life, psychological burden, needs, and satisfaction during specialized inpatient palliative care in family caregivers of advanced cancer patients. BMC Palliat Care. 2017 May 10;16(1):31. doi: 10.1186/s12904-017-0206-z.
Valero-Cantero I, Casals C, Espinar-Toledo M, Baron-Lopez FJ, Martinez-Valero FJ, Garcia-Agua Soler N, Vazquez-Sanchez MA. Effect of Self-Chosen Music in Alleviating the Burden on Family Caregivers of Patients with Advanced Cancer: A Randomised Controlled Trial. Int J Environ Res Public Health. 2023 Mar 6;20(5):4662. doi: 10.3390/ijerph20054662.
Valero-Cantero I, Martinez-Valero FJ, Espinar-Toledo M, Casals C, Baron-Lopez FJ, Vazquez-Sanchez MA. Complementary music therapy for cancer patients in at-home palliative care and their caregivers: protocol for a multicentre randomised controlled trial. BMC Palliat Care. 2020 May 2;19(1):61. doi: 10.1186/s12904-020-00570-9.
Milagros Reyes Sánchez, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
María Angeles Vázquez Sánchez, Doctor
Universidad de Málaga
Nuria Garcia-Agua Soler, Doctor
Universidad de Málaga
Cristina Casals Vázquez, Doctor
University of Cadiz
Francisco Martínez Valero, Podólogo
Clinica de Podologia
Ernesto Suárez Cadenas, Doctor
Universidad de Granada
Librado Valverde, Nurse
Distrito Sanitario Málaga- Guadalhorce. Servicio Andaluz de Salud
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 14, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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