Condition category
Cancer
Date applied
17/03/2010
Date assigned
07/05/2010
Last edited
16/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Leslie Walker

ORCID ID

Contact details

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

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 patient’s 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

http://www.hey.nhs.uk

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

Publication citations

Additional files

Editorial Notes