Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R0584
Study information
Scientific title
A feasibility study of relaxation therapy plus autohypnotherapy for patients with thoracic or breast cancer undergoing radiotherapy
Acronym
HYPREL
Study hypothesis
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
Hull and East Yorkshire Research Ethics Committee approved on the 17th September 2007 (ref: 07/H1304/109)
Study design
Phase II randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase II
Drug names
Primary outcome measures
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 trial start date
18/07/2008
Overall trial end date
30/04/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Thirty patients (30)
Participant exclusion criteria
1. Unable to lie supine for medical reasons
2. History of functional psychosis
Recruitment start date
18/07/2008
Recruitment end date
30/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Rehabilitation
Kingston upon Hull
HU3 2PG
United Kingdom
Sponsor information
Organisation
Hull and East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
Hull Royal Infirmary
Anlaby Road
Kingston upon Hull
HU3 2JZ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Dimbleby Cancer Care (UK) (ref: YLD035)
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 provided at time of registration
Results - basic reporting
Publication summary