NCT01213745

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 21, 2010

Status Verified

October 1, 2010

Enrollment Period

1.8 years

First QC Date

October 1, 2010

Last Update Submit

October 20, 2010

Conditions

Keywords

lungcancerquality of life

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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

Study Arms (3)

Intervention

EXPERIMENTAL
Other: Intervention

Attention

EXPERIMENTAL
Other: Attention

Control

ACTIVE COMPARATOR
Other: Control

Interventions

Intervention
Attention
ControlOTHER
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Lung NeoplasmsNeoplasms

Interventions

MethodsNeuropsychological Tests

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Dr M O'Brien

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 4, 2010

Study Start

September 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 21, 2010

Record last verified: 2010-10

Locations