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

Lung Cancer Clinical Trial

Official title:

A Prospective Randomised Controlled Study to Investigate the Effectiveness of Using a Quality of Life Questionnaire to Target Interventions to Improve Quality of Life in Patients With Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01213745
• Other study ID #: CCR3454
• Status: Recruiting
• Phase: N/A
• First received: October 1, 2010
• Last updated: October 20, 2010
• Start date: September 2010
• Est. completion date: July 2012

Study information

• Verified date: October 2010
• Source: Royal Marsden NHS Foundation Trust
• Contact: Dr M O'Brien
• Phone: 02086613278
• Email: mary.o'brien[@]rmh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Intervention

• Attention

• Control

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life			No
Secondary	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			No