Condition category
Cancer
Date applied
14/04/2010
Date assigned
19/05/2010
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Donald Sharp

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

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 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 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

http://www.hey.nhs.uk/ShowContent.aspx?PageID=7

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

Publication citations

Additional files

Editorial Notes