QUALITY OF LIFE SUBSTUDY (UK only)

Background

Multimodal breast cancer therapy improves survival but also contributes to physical, sexual and psychological sequelae. These have been extensively documented for the first year of treatment and follow up. There are also late effects of treatment, such as the normal tissue effects of radiotherapy, the effect on body image of mastectomy and on sexual functioning from chemotherapy. We need to tease out the contribution of specific therapies on key aspects of quality of life.  

The SUPREMO Quality of Life (QoL) study is designed to provide designated secondary endpoints to the trial. We will assess the subjective impact of mastectomy and chemotherapy, with or without additional radiotherapy to the chest wall over a ten-year period.

Rationale for QoL measurement

The main priority is to select measures that are standardised and scientifically robust so that the data obtained are valid and reliable. We will use measures selected for other national breast cancer trials so we can compare results.

We expect the key effects of treatment and relapse on QoL to be on general symptoms such as fatigue, chest wall symptoms, appearance of the chest wall and psychological distress. Physical functioning, role and social functioning and specific adverse effects of treatment will also be recorded. 

The QoL domains of importance will therefore include the following:

*    a core quality of life measure to detect general effects of treatments on QoL
*    a breast cancer module to reflect specific symptoms and effects relating to the effects of treatment
*    a body image scale to assess the impact of treatment on appearance and attractiveness following surgery,       chemotherapy and radiotherapy
*    a measure of anxiety and depression that indicates clinical levels of distress

A preference for measures used in the ABC and START Trials emerged. There is sound knowledge of their performance and of analysis methods and interpretation of outcome data.

Measures

1. Quality of life: the EORTC core quality of life instrument EORTCQLQ-C30 (Aaronson et al, 1993). This is a 30 item cancer questionnaire comprising five functional scales (physical, role, cognitive, emotional and social), global quality of life, three symptom scales (fatigue, pain, nausea and vomiting) and a number of single items.

2. Breast cancer specific module EORTC BR-23. This is a 23 item questionnaire designed to be used together with EORTC QLQ-C30. It comprises scales related to chemotherapy specific side effects, shoulder-arm problems, body image, sexuality and future perspective (Sprangers et al, 1997).

3. Body image: The Body Image Scale - BIS (Hopwood et al 2001)
This is a 10-item scale designed specifically for use with cancer patients to assess aspects of attractiveness, sexual attractiveness and feelings or satisfaction with appearance. (4 items are included in the BR23 and will not be duplicated).

The BIS has very good psychometric properties and has been used in the ABC and START trials, as well as European breast cancer trials. A threshold score for a morbid level of body image concerns has not been derived but there is extensive reference data for subgroups of patients receiving mastectomy or conservative surgery, with or without chemotherapy or tamoxifen (Hopwood et al 2001, Hopwood et al 2002). 

4. Psychological Distress: The Hospital Anxiety and Depression Scale – HADS (Zigmond & Snaith 1983) 
The HADS is a 14-item scale (7 items for depression and 7 items for anxiety) designed to measure affective disorder in cancer patients. Threshold scores have been derived that enables the prevalence of clinical levels of anxiety or depression to be estimated. A comparison of instruments showed the HADS to be superior in measuring anxiety and depression when compared with a psychiatric interview (Ibbotson et al 1994) and it is the most widely used self-report measure of psychological distress used with cancer patients.  

5. An open-ended question, inviting comments from patients will be added at the end of the questionnaire booklet.

 Endpoints

Primary QoL endpoints will be:

1. Fatigue (QLQ-C30)
2. Physical functioning subscale (EORTC QLQ-C30)
3. Chest wall, shoulder and arm symptoms (EORTC BR23)
4. Body image  (BIS)
5. Anxiety and depression (HADS)

Plan of study

There will be a detailed multicentre study of the patients’ quality of life after chemotherapy and after additional radiotherapy in the experimental arm. QoL assessments will form an integral part of the trial for all consenting patients. Centres will choose whether or not to opt in to the QoL protocol but the geographic (and socio-economic) distribution of participating centres will be monitored to make sure that they are representative. 

The assessments will take the form of serial patient self-report questionnaires, using validated measures that have been used successfully in the ABC and START Trials. Baseline QoL compliance in the START Trial, involving over 2000 patients, was 98.5% and has remained high.

Eligibility: 

All patients from selected centres who:

*       consent to take part in the SUPREMO Trial
*       consent to take part in the QoL study
*       are willing and able to complete the questionnaires

Trial management 

This part of the trial will run under the guidance of Dr Galina Velikova.

Quality of Life Sub-study Co-ordinator

Joanne Mair
ISD Cancer Clinical Trials Team
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB
Telephone: +44 (0) 131 275 6209
E-mail: joanne.mair@isd.csa.scot.nhs.uk