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

October 20, 2010 updated by: Royal Marsden NHS Foundation Trust

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Other: Intervention
Active Comparator: Control
Other: Control
Experimental: Attention
Other: Attention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Dr M O'Brien, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (Estimate)

October 4, 2010

Study Record Updates

Last Update Posted (Estimate)

October 21, 2010

Last Update Submitted That Met QC Criteria

October 20, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR3454

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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