Comparing the effects of live versus recorded relaxation on mood, coping, and quality of life on patients with cancer

ISRCTN	ISRCTN72222248
DOI	https://doi.org/10.1186/ISRCTN72222248
Protocol serial number	R0578
Sponsor	Hull & East Yorkshire Hospitals NHS Trust (UK)
Funder	Hull & East Yorkshire Hospitals NHS Trust (UK) - Endowment Funds

Submission date: 17/03/2010
Registration date: 07/05/2010
Last edited: 16/10/2015

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Leslie Walker
Scientific

Institute of Rehabilitation
215 Anlaby Road
Kingston upon Hull
HU3 2PG
United Kingdom

Study information

Primary study design	Interventional
Study design	Single centre prospective pragmatic randomised active controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pragmatic, randomised controlled trial of the effects of live relaxation on mood, coping, and quality of life on patients with cancer
Study acronym	LIVEREL
Study objectives	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(s)	Hull & East Riding Local Research Ethics Committee approved on the 18th of September 2007 (ref: 07H1304/110)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	01/07/2011
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	156
Key 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
Key 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.
Date of first enrolment	01/01/2008
Date of final enrolment	01/07/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Rehabilitation

Kingston upon Hull
HU3 2PG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes