NCT01337102

Brief Summary

In the treatment of advanced cancer, maximizing quality of life (QoL) is a fundamental goal for oncologists and their patients. In order to achieve this goal, some form of systematic and reliable QoL assessment is needed in routine clinical practice to evaluate the impact of advanced cancer treatments on QoL. The Lung Cancer Symptom Scale (LCSS) is a validated site-specific QoL measure designed for use in patients with lung cancer undergoing treatment. Recently it has been developed into an electronic form that uses a hand-held pocket personal computer (pc) to enhance collection and presentation of QoL assessments into clinical trials and patient care. This study will evaluate the impact of this computer-generated QoL (LCSS-QL) assessment on treatment practices for advanced lung cancer patients using a randomized trial design. The investigators hypothesize that a Computer-Generated Quality of Life Assessment Program will positively impact treatment patterns for patients with lung cancer. Specifically, the investigators hypothesize:

  1. 1.Use of the LCSS-QL will increase and accelerate referral to and use of palliative care services;
  2. 2.Use of the LCSS-QL will decrease the duration of palliative chemotherapy treatment with earlier identification of lack of benefit in some patients;
  3. 3.Use of the LCSS-QL may decrease the use of imaging tests to assess objective tumor response as an indicator of treatment benefit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2004

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

6.9 years

First QC Date

April 5, 2011

Last Update Submit

March 10, 2017

Conditions

Non Small Cell Lung Cancer

Keywords

Lung CancerStage 3bStage 4First Line Chemotherapy TreatmentQuality Of LifePalliative CareRandomizedLung Cancer Scale

Outcome Measures

Primary Outcomes (2)

  • Number of Palliative care Referrals.

    To assess the impact of use of the LCSS-QL on palliative care referrals;

    Approximately 12 - 18 weeks

  • Number of palliative first-line chemotherapy cycles administered.

    To assess the impact of use of the LCSS-QL on the number of palliative first-line chemotherapy cycles administered

    Approximately 12 - 18 weeks

Secondary Outcomes (3)

  • Use of supportive treatments.

    12 - 18 weeks

  • Number of imaging tests ordered.

    Approximately 12 - 18 weeks

  • Differences between study arm scores

    Approximately 12 - 18 weeks

Study Arms (2)

Physician to receive results

OTHER

Arm 1 Physician to receive the results of the Lung QoL scale

Procedure: Physician Receives QoL results

Physician Does Not Receive Results

OTHER

Arm 2 Physician does not receive the results of the Lung QoL scale

Procedure: Physician Does not receive the results

Interventions

Physician Receives QoL resultsPROCEDURE

Patient completes the Lung Cancer QoL scale on the Palm held computer device and the Physician receives the print out of the results.

Physician to receive results
Physician Does not receive the resultsPROCEDURE

Patient completes the Lung Cancer QoL scale on the Palm held computer device and the Physician does not receive the print out of the results.

Physician Does Not Receive Results

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Primary Non Small Cell Lung Cancer
  • Stage 3 or 4 Lung Cancer
  • To receive 1st line Chemotherapy
  • Platinum based chemotherapy or Non Platinum
  • Physical ability to use the hand held device(adequate vision, manual dexterity),
  • ECOG 1-2
  • Written fluency in English, French, Italian, Spanish, Portuguese or Chinese

You may not qualify if:

  • Patients will be excluded if they are unable to complete or understand the assessment process,
  • If they are receiving concurrent radical radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • NATASHA LEIGHL, MD MSC

    UNIVERSITY HEALTH NETWORK / PRINCESS MARGARET HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 18, 2011

Study Start

November 1, 2004

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

March 14, 2017

Record last verified: 2017-03

Locations

CA(1)