The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial

Marc Serfaty, Michael King, Irwin Nazareth, Adrian Tookman, John Wood, Anna Gola, Trefor Aspden, Kathryn Mannix, Stirling Moorey, Louise Jones

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Abstract

Background
The prevalence of depressive disorder in adults with advanced cancer is around 20 %. Although cognitive behavioural therapy (CBT) is recommended for depression and may be beneficial in depressed people with cancer, its use for depression in those with advanced disease for whom cure is not likely has not been explored.

Methods
People aged 18 years and above with advanced cancer attending General Practitioner (GP), oncology or hospice outpatients from centres across England will be screened to establish a DSM-IV diagnosis of depression. Self-referral is also accepted. Eligible consenters will be randomised to a single blind, multicentre, randomised controlled trial of the addition to treatment as usual (TAU) of up to 12 one-hour weekly sessions of manualised CBT versus TAU alone. Sessions are delivered in primary care through Increasing Access to Psychological Care (IAPT) service, and the manual includes a focus on issues for people approaching the end of life. The main outcome is the Beck Depression Inventory-II (BDI-II). Subsidiary measures include the Patient Health Questionnaire, quality of life measure EQ-5D, Satisfaction with care, Eastern Cooperative Oncology Group-Performance Status and a modified Client Service Receipt Inventory. At 90 % power, we require 240 participants to enter the trial. Data will be analysed using multi-level (hierarchical) models for data collected at baseline, 6, 12, 18 and 24 weeks. Cost effectiveness analysis will incorporate costs related to the intervention to compare overall healthcare costs and QALYs between the treatment arms. We will conduct qualitative interviews after final follow-up on patient and therapist perspectives of the therapy.

Discussion
This trial will provide data on the clinical and cost effectiveness of CBT for people with advanced cancer and depression. We shall gain an understanding of the feasibility of delivering care to this group through IAPT. Our findings will provide evidence for policy-makers, commissioners and clinicians in cancer and palliative care, and in the community.

Trial registration
Controlled Trials ISRCTN07622709, registered 15 July 2011
Original languageEnglish
Article number113
JournalTrials
Volume17
Issue number1
DOIs
Publication statusPublished - 29 Feb 2016

Keywords

  • pallative care
  • cognitive behavioural therapy
  • cognitive behaviour therapy
  • patient health questionnaire
  • client service receipt inventory
  • Drug Costs
  • Quality-Adjusted Life Years
  • Single-Blind Method
  • Humans
  • Clinical Protocols
  • England
  • Cognitive Behavioral Therapy/economics
  • Treatment Outcome
  • Combined Modality Therapy
  • Antidepressive Agents/economics
  • Psychiatric Status Rating Scales
  • Time Factors
  • Cost-Benefit Analysis
  • Quality of Life
  • Depressive Disorder, Major/economics
  • Neoplasms/complications
  • Research Design

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