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

Phase 2

Completed

• Conditions: ung cancer, oesophageal cancer or breast cancer; Cancer; Malignant neoplasm of the lung

• Registration Number: ISRCTN89999034
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-04-30
• Study Start: 2010-05-19
• Last Update Posted: 1 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

1. Unable to lie supine for medical reasons
2. History of functional psychosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. Differences between groups in the frequency and amplitude of chest wall movement at other time points<br> 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<br>