Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R0578
Study information
Scientific title
A pragmatic, randomised controlled trial of the effects of live relaxation on mood, coping, and quality of life on patients with cancer
Acronym
LIVEREL
Study hypothesis
1. In patients attending the Oncology Health Centres for the first time, what is the relative effectiveness of live relaxation "LIVEREL" and recorded relaxation "RECREL" (i.e. "treatment as usual" including audio recorded relaxation as part of support within the Oncology Health Centres) on mood, coping and quality of life?
2. What is the relative cost-effectiveness of LIVEREL and RECREL?
3. What are the immediate effects of live versus recorded relaxation instructions on blood pressure and pulse rate?
If patients randomised to LIVEREL have significantly higher relaxation scores on the Mood Rating Scale than those randomised to RECREL, we would conclude that the beneficial effects of LIVEREL was due to the extra social contact and/or the effects of live feedback on performance.
Ethics approval
Hull & East Riding Local Research Ethics Committee approved on the 18th of September 2007 (ref: 07H1304/110)
Study design
Single centre prospective pragmatic randomised active controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Various cancers; colorectal, gynaecological cancer (ovarian, endometrial, cervical) lung, or prostate
Intervention
All interventions will be carried out in the Oncology Health Centres at Castle Hill and Princess Royal Hospitals, Kingston upon Hull (House of Commons, 2004; Walker et al., 2003 a and b).
Patients will be randomised to one of two interventions:
1. Patients randomised to RECREL will be taught progressive muscular relaxation and cue-controlled relaxation (Hutchings et al., 1980), with imagery of the patients choice, by means of audio recordings based on scripts used in our previous studies of patients with breast cancer, colorectal cancer, and lymphoma, and with healthy volunteers (Johnson et al., 1996; Ratcliffe et al., 1995, Walker et al., 1999a). Each therapist will record these scripts in his/her own voice. Patients will be asked to practice once daily at home for 8 weeks (daily diary records to be kept). To control for patient contact, they will receive three audio recorded training sessions (progressive muscular relaxation, with or without guided imagery) at weeks, 1, 2 and 4 in the Oncology Health Centres.
2. Patients randomised to LIVEREL will receive the same audio recordings and will be given identical instructions to practice daily at home for 8 weeks. In addition, they will be given three sessions of live training (40 minutes) at weekly intervals from our clinical nurse specialists (behavioural oncology).
An external consultant skilled in these methods will assess the competency of each of the nurses and their ability to adhere to the protocol. In addition, to ensure protocol adherence, a random sample of live sessions will be observed by a clinical psychologist during the study period.
All patients will be invited to attend, or telephone, one of the Oncology Health Centres whenever they wish, and they will receive treatment as usual in the Centres when they attend (House of Commons, 2004; Walker et al., 2003 a and b). This includes access to the Clinical and Research Nurse Specialists (Behavioural Oncology) and, if indicated clinically, the clinical psychologists. All patients with clinically significant problems will receive treatment according to current local practice and any psychosocial or psychopharmacological interventions will be documented. They will also have access to other support services.
Records of telephone and other contact with the Centres will be kept (using the contact cards used in previous studies).
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
Relaxation scale score on the Mood Rating Scale (MRS), (Anderson et al., 2000; Johnson et al., 1996; Walker et al., 1997; Walker et al., 1999; Wesnes et al., 1997b), measured at 8 weeks
Secondary outcome measures
1. Functional Assessment of Cancer Therapy: General version (FACT-G) (Cella et al., 1993)
2. Hospital Anxiety and Depression Scores (HADS) (Hermann, 1997; Walker et al., 1999; Zigmond & Snaith, 1983)
3. Mood Rating Scale (MRS) (remaining scales) (Anderson et al., 2000; Johnson et al., 1996; Walker
et al., 1997; Walker et al., 1999; Wesnes et al., 1997)
4. Brief Profile of Mood States (Cella et al, 1987)
5. EuroQol (EQ-5D) (Brooks, 1996; EuroQoL Group, 1990)
6. Health Service Use (HSU)
7. Social Support Questionnaire (SSQ)
8. Patient Satisfaction Questionnaire (PSQ) (Walker et al., 1999)
All secondary outcomes will be measured at 4 and 12 weeks.
Overall trial start date
01/01/2008
Overall trial end date
01/07/2011
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. At least 18 years of age
2. Histologically confirmed colorectal cancer, gynaecological cancer (ovarian, endometrial, cervical) lung, or prostate cancer.
3. Accessing the Oncology Health Service for the first time
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
156
Participant exclusion criteria
1. WHO performance status 2, 3 and 4;
2. Clinically significant cognitive impairment or dementia
3. Inability to complete Quality of Life questionnaires
4. Inability or unwillingness to give informed consent
5. History of functional psychosis.
Recruitment start date
01/01/2008
Recruitment end date
01/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Rehabilitation
Kingston upon Hull
HU3 2PG
United Kingdom
Sponsor information
Organisation
Hull & East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
Hull Royal Infirmary
Anlaby Road
Kingston upon Hull
HU3 2JZ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hull & East Yorkshire Hospitals NHS Trust (UK) - Endowment Funds
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary