Back to results

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

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Attention

Control

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring lung, cancer, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Royal Marsden NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Attention

Control

Arm Description

Outcomes

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

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

Full Information

NCT ID

NCT01213745

First Posted

October 1, 2010

Last Updated

October 20, 2010

Sponsor

Royal Marsden NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT01213745

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

lung, cancer, quality of life

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Title

Attention

Arm Type

Experimental

Arm Title

Control

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Intervention

Intervention Type

Other

Intervention Name(s)

Attention

Intervention Type

Other

Intervention Name(s)

Control

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dr M O'Brien

Phone

02086613278

mary.o'brien@rmh.nhs.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Mr M Laybourne

Phone

02086613835

matthew.laybourne@rmh.nhs.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr M O'Brien

Organizational Affiliation

Royal Marsden NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Marsden NHS Foundation Trust

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr M O'Brien

Phone

02086613278

mary.o'brien@rmh.nhs.uk

First Name & Middle Initial & Last Name & Degree

Mr M Laybourne

Phone

02086613835

matthew.laybourne@rmh.nhs.uk

First Name & Middle Initial & Last Name & Degree

Dr Mary O'Brien

12. IPD Sharing Statement

Citations:

PubMed Identifier

26556778

Citation

Nimako K, Ayite B, Priest K, Severn J, Fries HM, Gunapala R, Bhosle J, Popat S, O'Brien M. A randomised assessment of the use of a quality of life questionnaire with or without intervention in patients attending a thoracic cancer clinic. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12402. Epub 2015 Nov 10.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs