Name:	SMaRT Oncology-3 Pilot
Title:	Symptom Management Research Trials - SMaRT Oncology-3 Pilot
Researchers:	Professor Michael Sharpe
Funding Body:	Cancer Research UK
Funding Awarded:	£4,000,000
Start Date:	01/10/2008
End Date:	31/12/2008

 

Aims:

1. To test the feasibility and acceptability of procedures and
2. Obtain data to inform the sample size calculation for the SMaRT Oncology-3 Trial.

Design:

a two arm parallel group randomised controlled pilot trial.

Patients: Patients who have a diagnosis of cancer (of various types), have an estimated life expectancy of between 3 and 12 months and who also have a diagnosis of major depressive disorder. Patients will be recruited from selected outpatient clinics of the Edinburgh Cancer Centre through an established systematic Symptom Monitoring Service and by clinician referrals.

Interventions:

Patients will be randomised to receive either usual care or usual care supplemented by a multi-component intervention (Depression Care for People with Cancer).

• Usual Care: The patients GP and oncologist will be informed of their diagnosis of MDD. The patient will then receive the usual clinical management of depression as currently practised.
• Usual care + Multi-component Intervention: The patient will receive usual care as described. A care manager will co-ordinate the patients depression care, monitor their symptoms and deliver a brief psychological intervention according to a pre-specified manual.

Outcomes:

Acceptability of the trial procedures to patients and carers will be assessed by open-ended interviews at baseline and at 12 and 24 weeks after randomisation. Feasibility of the trial procedures will be assessed by regular reviews, co-ordinated by the Trial Management Committee.