The Use of a Quality of Life Questionnaire in Patients Wi... | NCT01213745

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

NCT01213745

Sponsor

Royal Marsden NHS Foundation Trust

Status

Unknown status

Last Update Posted

Oct 21, 2010Estimated

Enrollment

138Estimated

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

Intervention
Attention
Control

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jul 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Oct 1, 2010

First Submission Date that Met QC Criteria

Oct 1, 2010

First Posted Date

Oct 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2010

Last Update Posted Date

Oct 21, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Intervention	Experimental	Other: Intervention
Attention	Experimental	Other: Attention
Control	Active Comparator	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intervention	Other		Intervention
Attention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr M O'Brien	Contact	02086613278		mary.o'brien@rmh.nhs.uk
Mr M Laybourne	Contact	02086613835		matthew.laybourne@rmh.nhs.uk

Overall Officials

Name	Affiliation	Role
Dr M O'Brien	Royal Marsden NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Marsden NHS Foundation Trust	Recruiting	Sutton		SM2 5PT	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26556778	Derived	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.

ID	Term
D008175	Lung Neoplasms
D009369	Neoplasms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases

ID	Term
D008722	Methods
D009483	Neuropsychological Tests

ID	Term
D008919	Investigative Techniques
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities