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Trial registered on ANZCTR


Trial ID
ACTRN12606000183583
Ethics application status
Approved
Date submitted
16/05/2006
Date registered
17/05/2006
Date last updated
9/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A psychoeducational intervention for patients with lung cancer.
Scientific title
The effectiveness of a psychoeducational program on the psychological, information needs, and quality of life of patients with lung cancer.
Universal Trial Number (UTN)
Trial acronym
LRCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 1156 0
Condition category
Condition code
Cancer 1238 1238 0 0
Lung - Mesothelioma
Cancer 1239 1239 0 0
Lung - Non small cell
Cancer 1240 1240 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two tailored, one hour, pyscho-educational sessions with feedback on baseline psychosocial needs to key members of the multidisciplinary team. The first psychoeducational session is delivered at treatment commencement and the second is delivered within 8 weeks of baseline, as close as possible to treatment completion.
Intervention code [1] 1044 0
Other interventions
Comparator / control treatment
The control group receives standard care.
Control group
Active

Outcomes
Primary outcome [1] 1675 0
Reduction in unmet information needs at 12 week follow-up is the primary outcome.
Timepoint [1] 1675 0
Questionnaires are administered at baseline, at 8 weeks and 12 weeks post baseline. The first psychoeducational session in the intervention occurs after baseline, and the second occurs prior to 8 week follow up.
Secondary outcome [1] 3003 0
Questionnaires
Timepoint [1] 3003 0
Administered at baseline, at 8 weeks and 12 weeks post baseline.
Secondary outcome [2] 3004 0
The first psychoeducational session session in the intervention occurs after baseline, and the second occurs prior to 8 week follow up.
Timepoint [2] 3004 0
Secondary outcome [3] 3005 0
Reduction in psychological distress
Timepoint [3] 3005 0
At 12 week follow-up is the key secondary outcome.

Eligibility
Key inclusion criteria
1) Diagnosis of inoperable lung cancer, mesothelioma or pleural cancer; 2) ECOG performance status less than or equal to 2; 3) Scheduled to receive external beam radiotherapy with or without concurrent chemotherapy, or scheduled to receive palliative intent chemotherapy only with no other treatment modality.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Delirium or dementia2) Psychosis3) Insufficient English to read the consent form independently4)Scheduled to receive surgery as a form of treatment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated sequence of random numbers is used for patient randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
two group randomised controlled trial
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1356 0
Government body
Name [1] 1356 0
NHMRC
Address [1] 1356 0
Country [1] 1356 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 1197 0
None
Name [1] 1197 0
Nil
Address [1] 1197 0
Country [1] 1197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2713 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 2713 0
Ethics committee country [1] 2713 0
Australia
Date submitted for ethics approval [1] 2713 0
Approval date [1] 2713 0
26/07/2004
Ethics approval number [1] 2713 0
04/39

Summary
Brief summary
While patients with advanced cancer have high levels of unmet needs, a recent systematic review indicated that very few trials of psychosocial interventions have been conducted with palliative patients, and none have been conducted with lung cancer patients. The present research aims to evaluate a supportive care program for patients with inoperable lung cancer who have a potentially limited life expectancy, using a randomised controlled design.
210 patients will be recruited and asked to fill out baseline measures of anxiety/depression, unmet needs and quality of life. Participants will then be randomised to receive either the intervention or usual care. Permission will be sought from participants to obtain information about medical variables from their medical record. Oncologists will provide information about each participant’s treatment plan, performance status, and awareness of prognosis, and will refer intervention participants to two supportive care sessions.
Participants will be encouraged to bring a significant other(s) with them to the supportive care sessions. The content of each session will be tailored to respond to needs identified in the baseline data. The first group session will be timed to correspond with the beginning of treatment, and the second will occur at the end of treatment. In addition, baseline data summaries for each intervention patient will be made available to the treating team to assist them in meeting the patient’s needs. Where particular needs are identified, appropriate referrals will be made (e.g. to social work, psychology etc) by the Lung clinical nurse coordinator.
Follow-up measures (anxiety/depression, unmet needs, quality of life and needs related to treatment preparation) will be administered at 8 and 12 weeks post baseline when patients attend the clinic at these approximate time points.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35118 0
Address 35118 0
Country 35118 0
Phone 35118 0
Fax 35118 0
Email 35118 0
Contact person for public queries
Name 10233 0
Penelope Schofield
Address 10233 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006
Country 10233 0
Australia
Phone 10233 0
+61 3 96563560
Fax 10233 0
+61 3 96561337
Email 10233 0
Penelope.Schofield@petermac.org
Contact person for scientific queries
Name 1161 0
Penelope Schofield
Address 1161 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006
Country 1161 0
Australia
Phone 1161 0
+61 3 96563560
Fax 1161 0
+61 3 96561337
Email 1161 0
Penelope.Schofield@petermac.org