Palliative Care Clinical Trial
— COMTHECAREOfficial title:
Complementary Therapy in Home Palliative Care Patients and Their Caregivers. A Clinical Trial
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:
- To evaluate the efficiency and cost-effectiveness of a music intervention program,
applied as a complementary therapy, in oncological palliative care patients and carers
at home, compared to current treatment.
- To assess if patients in the intervention group submit significant differences
regarding: pain, anxiety, depression, modo, insomnia, and life quality.
- To assess if carers in the intervention group present significant differences regarding
the Caregiver Burden Scale and life quality.
- To evaluate patients and carers satisfaction on the therapeutic intervention.
- To estimate the cost-effectiveness of the intervention.
Method:
Randomised, double-blind, multi-centre clinical trial in the field of primary health care,
conducted in 5 clinical management units belonging to Málaga-Guadalhorce health district and
performed in oncological palliative care patients and carers. Two samples of 40 palliative
care patients and two samples of 41 carers. The intervention group will undergo a 7-days
intervention with music sessions, the control group will be given seven sessions of
retraining in therapeutical education. Objectives will be evaluated through the following
tools: Edmonton Scale, Symptom Assessment System, EORTC QLQ-C30, Caregiver Burden Scale,
Pittsburgh Sleep Quality Index, Accelerometer, Epworth Sleepiness Scale (ESS), The Quality of
Life Family Version, Client Satisfaction Questionnaire and Economical valuation.
To assess the objectives evaluations will be performed through home visit, both
pre-intervention and a week after the beginning of the intervention for both groups. A
follow-up visit will be made a month after the intervention to regard some economical
parameters.
Statistical analysis:
The basal values of both groups will be compared. These values will be compared before and
after the intervention, in the control and intervention group through Student t-test for
normal continuous variables, and through Wilcoxon t-test for paired data in not normal
continuous variables. In addition to the bivariated analysis, a multiple lineal regression
will be carried out. The economical valuation will be a cost-effectiveness analysis. For each
group we will measure cost, incremental cost, AVAC effectiveness, incremental effectiveness,
dominance and, in case there is none, the results will be expressed in terms of incremental
cost-effectiveness. To assess the costs, direct sanitary costs and intervention related costs
will be considered.
SPSS 23 will be the statistical software to use, along with Epidat 3.01. 95% confidence range
will make p values under 0,05 (p<0.05) statistically significant.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | January 2022 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Oncological patients in palliative care at their homes, older than 18 years old, and their formal caregiver, in case they have one. - Patients who have given their consent to be included in the study. Exclusion Criteria: - Oncological patients in palliative care at their homes, with diseases in an advanced stage and a short life expectancy (last days). - Oncological patients with late stages dementia or psychological pathologies, not being capable of taking conscious decisions. - Oncological patients with hypoacusis or profound deafness, hindering the use of the mp3 player or mobile phone. |
Country | Name | City | State |
---|---|---|---|
Spain | Inmaculada Valero Cantero | Málaga |
Lead Sponsor | Collaborator |
---|---|
Andaluz Health Service | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
Spain,
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. Review. — View Citation
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- — View Citation
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. — View Citation
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. Review. — View Citation
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 Fe — View Citation
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. Review. — View Citation
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 patient — View Citation
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- — View Citation
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. — View Citation
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. Portuguese. — View Citation
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 — View Citation
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. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | Availability of payment | The contingent valuation method will be used to determine the readiness to pay. Patients | Postintervention (7 day) | |
Primary | 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) | |
Secondary | Sociodemographic data from palliative care patients | Age, sex, civil status, education level, time in palliative care, and disease they receive the care for. | Preintervention (0 day) | |
Secondary | Sociodemographic data from caregivers | Age, sex, civil status, education level, out-of-home job, time dedicated to caring, help received for caring, total time taking care of someone, and relation to the person taken care of. | Preintervention (0 day) |
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