ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

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

Condition category

Condition code

Cancer

Lung - Mesothelioma

Cancer

Lung - Non small cell

Cancer

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]

Other interventions

Comparator / control treatment

The control group receives standard care.

Control group

Active

Outcomes

Primary outcome [1]

Reduction in unmet information needs at 12 week follow-up is the primary outcome.

Timepoint [1]

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]

Questionnaires

Timepoint [1]

Administered at baseline, at 8 weeks and 12 weeks post baseline.

Secondary outcome [2]

The first psychoeducational session session in the intervention occurs after baseline, and the second occurs prior to 8 week follow up.

Timepoint [2]

Secondary outcome [3]

Reduction in psychological distress

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/01/2005

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

210

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Peter MacCallum Cancer Centre

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/07/2004

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Penelope Schofield

Address

Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006

Country

Australia

Phone

+61 3 96563560

Fax

+61 3 96561337

Penelope.Schofield@petermac.org

Contact person for scientific queries

Name

Penelope Schofield

Address

Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006

Country

Australia

Phone

+61 3 96563560

Fax

+61 3 96561337

Penelope.Schofield@petermac.org

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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