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

NCT ID: NCT01213745

Last Updated: 2010-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

Group Type EXPERIMENTAL

Intervention

Intervention Type OTHER

Attention

Group Type EXPERIMENTAL

Attention

Intervention Type OTHER

Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Interventions

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Intervention

Intervention Type OTHER

Attention

Intervention Type OTHER

Control

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Royal Marsden NHS Foundation Trust

Principal Investigators

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Dr M O'Brien

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dr M O'Brien

Role: CONTACT

Mr M Laybourne

Role: CONTACT

02086613835

Facility Contacts

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Dr M O'Brien

Role: primary

Mr M Laybourne

Role: backup

02086613835

References

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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.

Reference Type DERIVED
PMID: 26556778 (View on PubMed)

Other Identifiers

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CCR3454

Identifier Type: -

Identifier Source: org_study_id