A study exploring the practicality and effectiveness of relaxation therapy plus autohypnotherapy for patients with breast and lung cancer undergoing radiotherapy

ISRCTN ISRCTN89999034
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

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
Email James.Illingworth@hey.nhs.uk

Study information

Study designPhase II randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA feasibility study of relaxation therapy plus autohypnotherapy for patients with thoracic or breast cancer undergoing radiotherapy
Study acronymHYPREL
Study objectivesThe 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) studiedLung cancer, oesophageal cancer or breast cancer
InterventionPatients 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 typeOther
Primary outcome measureDuring 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 patient’s 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 measures1. 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 date18/07/2008
Completion date30/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsThirty patients (30)
Key inclusion criteria1. 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 criteria1. Unable to lie supine for medical reasons
2. History of functional psychosis
Date of first enrolment18/07/2008
Date of final enrolment30/04/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Rehabilitation
Kingston upon Hull
HU3 2PG
United Kingdom

Sponsor information

Hull and East Yorkshire Hospitals NHS Trust (UK)
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
ROR logo "ROR" https://ror.org/01b11x021

Funders

Funder type

Charity

Dimbleby Cancer Care (UK) (ref: YLD035)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

13/06/2019: Contact details updated.