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

R

Royal Marsden NHS Foundation Trust

Status

Unknown

Conditions

Lung Cancer

Treatments

Other: Intervention
Other: Attention
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT01213745
CCR3454

Details and patient eligibility

About

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.

Full 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.

Enrollment

138 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

138 participants in 3 patient groups

Intervention
Experimental group
Treatment:
Other: Intervention
Attention
Experimental group
Treatment:
Other: Attention
Control
Active Comparator group
Treatment:
Other: Control

Trial contacts and locations

1

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Central trial contact

Dr M O'Brien; Mr M Laybourne

Data sourced from clinicaltrials.gov

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