Plain English Summary
Background and study aims
Cancer patients often suffer from emotional distress such as anxiety or depression. The presence of these symptoms in combination with the physical symptoms of cancer, such as pain and nausea (feeling sick), can have a negative effect on overall quality of life. Progressive muscle relaxation is a technique which involves relaxing muscles through a two-step process: Tensing specific muscle groups followed by releasing the tension and noticing the feeling when relaxing the muscles. This exercise can be an effective way to lower overall tension and stress levels, and help people to relax when they are feeling anxious. The aim of this study is to find out whether this muscle relaxation technique can help reduce levels of anxiety and pain in cancer patients, leading to an improved quality of life.
Who can participate?
Adult cancer patients experiencing anxiety, muscle tension, sleeping difficulties, sadness, or anxiety attacks
What does the study involve?
Participants attend a single session where they learn the muscle relaxation technique. The session takes place in a comfortable room with a trained instructor, either individually or in groups. After the session, participants are encouraged to perform the technique at home at least once a day for the duration of the study. At the start of the study and then every week for a month, participants complete a number of questionnaires to assess their anxiety, pain and nausea levels. In addition, they are asked about their medication use at the same times.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
Hospital Universitario Marques de Valdecilla and nine other hospitals in Spain.
When is the study starting and how long is it expected to run for?
February 2014 to May 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Paula Parás-Bravo
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Proyecto tesis
Study information
Scientific title
Is the muscle relaxation technique capable of improving the quality of life of cancer patients with anxiety and pain?
Acronym
Study hypothesis
The progressive muscle relaxation technique in its abbreviated version reduces symptoms of anxiety and pain in cancer patients, leading to improved quality of life.
Ethics approval
1. Ethical Committee of Cantabria, 29/05/2014, ref: 2014.097
2. Alcorcon Hospital Ethics Committee, 03/11/2014
3. Ethical Committee Fuenlabrada Hospital, 03/12/2014
4. Ethical Committee Getafe Hospital, 26/06/2014, ref: A13-14
5. Ethical Committee Puerta Del Hierro Hospital, 27/07/2014, ref: Huph Pi92/14
6. Ethical Committee Instituto Catalan Oncologia Badalona,14/11/2014, ref: Jacobson 01/2014
7. Ethical Committee Instituto Catalan Oncologia Hospitalet, 10/09/2014, ref: Acta 15-14
8. Ethics Committee Salamanca Hospital, 18/07/2014
9. Sierrallama Hospital Ethics Committee, 01/08/2014, ref: 2014.097
10. Committee Etica Complex Hospitalario Navarra, 01/02/2015, ref: Pyto 2015/14
Study design
Non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Anxiety, pain and nausea in cancer patients
Intervention
All participants receive a guided session in order to learn abbreviated progressive muscle relaxation training by following Bernstein and Borkovec. These sessions are conducted individually or in groups, according to the patients’ condition. All researchers who perform the intervention are fully trained regarding the selection criteria, information provided to participants, data collection procedures and application of the technique in order to unify criteria and reduce possible inter-examiner bias. All researchers receive a written guidance document for the relaxation session. The patients perform the technique in a sitting position in rooms furnished with armchairs, cushions, pleasant lighting and an overall quiet environment. Each session last approximately 60 minutes and is divided into the following 4 parts:
1. An explanation regarding the characteristics of the abbreviated progressive muscle relaxation training by Bernstein and Borkovec
2. Application of a relaxation session
3. Answering possible questions
4. Data collection using the self-administered FACT-G questionnaire and the data collection notebook.
At the end of the session, patients are provided with information regarding the intervention consisting of a brief description of the session, based on text and images, in order to support the performance of this technique at their respective homes. Participants are advised to perform the technique at home at least once a day for the duration of the study.
Participants are followed up weekly for one month.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Quality of life is measured using the FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire at baseline and weekly for four weeks (1 month)
2. Anxiety is measured using a visual analogue scale (VAS) at baseline and weekly for four weeks (1 month)
3. Pain is measured using a visual analogue scale (VAS) at baseline and weekly for four weeks (1 month)
4. Nausea is measured by asking participants a yes/no question about their nausea levels at baseline and weekly for four weeks (1 month)
Secondary outcome measures
1. Analgesic use is measured through patient interviews at baseline and weekly for four weeks (1 month)
2. Anxiolytic use is measured through patient interviews at baseline and weekly for four weeks (1 month)
3. Hypnotics use is measured through patient interviews at baseline and weekly for four weeks (1 month)
4. Antidepressant use is measured through patient interviews at baseline and weekly for four weeks (1 month)
Overall trial start date
01/02/2014
Overall trial end date
01/05/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18 years and over
2. Cancer patients
3. Experiencing anxiety, muscle tension, sleeping difficulties, sadness, or anxiety attacks
4. Provision of consent to participate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
272
Participant exclusion criteria
Patients suffering from hallucinations, delirium or other psychotic symptoms.
Recruitment start date
01/11/2014
Recruitment end date
01/10/2015
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Universitario Marques de Valdecilla
Av. Valdecilla, 25
Santander
39008
Spain
Trial participating centre
Hospital Fundación Alcorcon
Calle Budapest, 1
Madrid
28922
Spain
Trial participating centre
Hospital Universitario Fuenlabrada
Calle Camino del Molino, 2
Fuenlabrada
Madrid
28942
Spain
Trial participating centre
Hospital Universitario de Getafe
Carr. Madrid - Toledo, Km 12,500
Madrid
28905
Spain
Trial participating centre
Complejo Hospitalario Palmplona
Calle de Irunlarrea, 3
Palmplona
Navarra
31008
Spain
Trial participating centre
Hospital Sierrallana
Barrio de Ganzo, s/n
Cantabria
39300
Spain
Trial participating centre
Hospital Universitario de Salamanca
Paseo de San Vicente, 88-182
Castilla y Leon
37007
Spain
Trial participating centre
Instituto Catalan de Oncologia, Hospitalet
Hospital Duran i Reynals
Avinguda de la Granvia, 199-203
Barcelona
08908
Spain
Trial participating centre
Instituto Catalan de Oncologia, Badalona
Hospital Duran i Reynals
Avinguda de la Granvia, 199-203
Barcelona
08908
Spain
Trial participating centre
Hospital Universitario Puerta del Hierro
Calle Manuel de Falla, 1
Madrid
28222
Spain
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
Intention to publish date
31/12/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29720148