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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01213745
First received: October 1, 2010
Last updated: October 20, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Lung Cancer
 Other: Intervention
Other: Attention
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 138
Study Start Date: September 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Other: Intervention
Experimental: Attention Other: Attention
Active Comparator: Control Other: Control

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213745

Contacts
Contact: Dr M O'Brien 02086613278 mary.o'brien@rmh.nhs.uk
Contact: Mr M Laybourne 02086613835 matthew.laybourne@rmh.nhs.uk

Locations
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Dr M O'Brien     02086613278     mary.o'brien@rmh.nhs.uk    
Contact: Mr M Laybourne     02086613835     matthew.laybourne@rmh.nhs.uk    
Principal Investigator: Dr Mary O'Brien            
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Dr M O'Brien Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Mary O'Brien, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01213745     History of Changes
Other Study ID Numbers: CCR3454
Study First Received: October 1, 2010
Last Updated: October 20, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
lung
cancer
quality of life

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013