A study exploring the practicality and effectiveness of relaxation therapy plus autohypnotherapy for patients with breast and lung cancer undergoing radiotherapy
ISRCTN | ISRCTN89999034 |
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DOI | https://doi.org/10.1186/ISRCTN89999034 |
Secondary identifying numbers | R0584 |
- Submission date
- 14/04/2010
- Registration date
- 19/05/2010
- Last edited
- 13/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Mr James Illingworth
Scientific
Scientific
Research and Development Department
Hull University Teaching Hospitals NHS Trust
Office 14, 2nd Floor Daisy Building
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom
Phone | +44 (0)1482 461903 |
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James.Illingworth@hey.nhs.uk |
Study information
Study design | Phase II randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A feasibility study of relaxation therapy plus autohypnotherapy for patients with thoracic or breast cancer undergoing radiotherapy |
Study acronym | HYPREL |
Study objectives | The aims are: 1. To develop a programme of cue-controlled relaxation and auto hypnosis (RELHYP) in order to facilitate predictable, regular, gentle breathing during planning and radiotherapy 2. To obtain preliminary evidence of feasibility and effectiveness 3. To validate an automated system for quantifying movement during planning radiotherapy 4.To obtain information about the effect size of the intervention to inform the design of a definitive randomised controlled trial (RCT) |
Ethics approval(s) | Hull and East Yorkshire Research Ethics Committee approved on the 17th September 2007 (ref: 07/H1304/109) |
Health condition(s) or problem(s) studied | Lung cancer, oesophageal cancer or breast cancer |
Intervention | Patients will be randomised to radiotherapy treatment as usual or HYPREL. HYPREL will consist of a standard, protocolised intervention consisting of: 1. Training in progressive muscular relaxation and cue controlled relaxation by means of audio recordings. Commencing on Day 1, patients will be asked to practice at least once daily until the completion of radiotherapy. They will keep a diary record as in previous studies. 2. Four sessions of protocolised live training in hypnotherapy consisting of training in autohypnosis (Spiegel eye roll technique, anchoring); rehearsal in imaguo, and ego strengthening. The timing of sessions will be: Sessions 1 and 2: between days 8 and 14 (in the OHC) Session 3: day 15 (in the CT planning suite (rehearsal in vivo) Session 4 (booster): day 42 (mid point of radiotherapy) |
Intervention type | Other |
Primary outcome measure | During radiotherapy, the frequency and amplitude of chest wall movement will be measured during RT1, RT10, and RT15 (last fraction of treatment for breast cancer) or RT20 (last fraction of treatment for thoracic cancer) using the Varian RPM system. This is an established system with an integrated software package for data retrieval and processing. It involves no direct patient contact. An infra-red camera is used to track a pair of reflective markers that are mounted on the front face of a small box which is placed on the patients chest. Apart from the placement of this box, the use of this equipment has no impact on the standard treatment. The motion of these markers acts as a surrogate for that of the chest itself and is used to measure its amplitude and frequency. The regularity of the breathing cycle of each patient will be characterised by the mean and standard deviation established over 40 breathing cycles. |
Secondary outcome measures | 1. Differences between groups in the frequency and amplitude of chest wall movement at other time points 2. Between-group differences in Mood Rating Scale (MRS), Brief State Anxiety Inventory (BSAI), Patient Satisfaction Questionnaire (PSQ) and Functional Assessment of Cancer Therapy (FACT) scores at all time points following randomisation |
Overall study start date | 18/07/2008 |
Completion date | 30/04/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Thirty patients (30) |
Key inclusion criteria | 1. Treatment to include at least 15 - 20 fractions of radical radiotherapy to the thorax or breast 2. Lung cancer, oesophageal cancer or breast cancer 3. Male or female 4. Age at least 18 years 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 6. Able to complete questionnaires 7. Able and willing to give written informed consent |
Key exclusion criteria | 1. Unable to lie supine for medical reasons 2. History of functional psychosis |
Date of first enrolment | 18/07/2008 |
Date of final enrolment | 30/04/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Rehabilitation
Kingston upon Hull
HU3 2PG
United Kingdom
HU3 2PG
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Hull Royal Infirmary
Anlaby Road
Kingston upon Hull
HU3 2JZ
England
United Kingdom
Website | http://www.hey.nhs.uk/ShowContent.aspx?PageID=7 |
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https://ror.org/01b11x021 |
Funders
Funder type
Charity
Dimbleby Cancer Care (UK) (ref: YLD035)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
13/06/2019: Contact details updated.