Clinical trial NCT01213745: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: lung
cancer
quality of life
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2010-10-04
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: 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: 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:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Dr M O'Brien
role: PRINCIPAL_INVESTIGATOR
References:
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.