The Use of a Quality of Life Questionnaire in Patients With Lung Cancer

Not Applicable

• Conditions: Lung Cancer
• Interventions: Other: Intervention; Other: Attention; Other: Control

• Registration Number: NCT01213745
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

This study will investigate the effectiveness of using the European Organisation for Research and Treatment of cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13) to identify and target therapies in patients with lung cancer. The study will assess whether using the questionnaire will result in an improvement in QoL.

Detailed Description

Patients with lung cancer who have completed a course of treatment (or who are in-between treatment) at the Royal Marsden Hospital would be eligible for inclusion in the study. Participants will be randomised into 3 groups. Group 1 - this group will complete the QoL questionnaire and will receive targeted therapies by a doctor (and other members of the oncology team) during a clinic consultation. Group 2 - will complete the QoL questionnaire however the questionnaire will not be seen by the doctor during a clinic consultation. Group 3 - the control group will not complete the QoL questionnaire before a clinic consultation. All patients will complete a diary of all contact they have with health care professionals during the study. The study will last for 6 weeks and at the end of the study all patients will complete the QoL questionnaire.

Study Timeline

• Study Start: 2010-09
• Status Verified: 2010-10
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Last Update Submitted: 2010-10-20
• Last Update Posted: 2010-10-21
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• male or female age > 18 years
• patients who are able to adequately understand written and spoken english
• diagnosis of lung cancer (non small cell, small cell, mesothelioma)
• no plan to commence treatment (chemotheraphy, targeted therapies, radioterhapy, surgery) with 6 weeks
• both radically or palliatively treated patients remain eligible
• patients whose toxicities from their primary treatment has resolved or have stabilised for a period of 7 days

Exclusion Criteria

• patients are taking part on any other QoL studies
• taking part in any other studies that requires QoL questionnaires, extra visits or investigations
• currently on treatment (chemotherapy, radiotherapy, surgery or targeted therapies)
• they have on going toxicities from their treatment which have not been stablised (required intervention within last 7 days)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	-
Attention	Attention	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life

Secondary Outcome Measures

Name	Time	Method
To investigate whether the use of EORTC QLQ-C30 + lung cancer module results in less patient contact with health care professionals during the 6 week study period for the 3 groups

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, United Kingdom