Dr Jane Turner1
Professor Brian Kelly2
Professor David Clarke3
1 The University of Queensland
2 University of Newcastle
3 Monash University and Southern Health
Priority-driven Collaborative Cancer Research Scheme (PdCCRS)
Project completion year
The aim of this study is to evaluate the effectiveness of a systematically introduced psychosocial intervention in cancer services to reduce depression and anxiety.
The primary measure of effectiveness of the intervention will be the difference in mean within-patient change in the Hospital Anxiety and Depression Scale (HADS) scores between the Intervention and Control epochs.
Secondary outcomes will be patient unmet needs (measured by Supportive Care Needs Survey), patient quality of life (measured by FACT-G) and scores of demoralisation (Demoralisation scale).
This study is underpinned by the need to deliver psychosocial care in a more timely and equitable manner using scarce existing resources judiciously. Wide-spread implementation of this model of care depends on patient benefit and the capacity of health professionals to deliver the therapy. Hence, secondary outcomes are psychological morbidity and levels of stress and burnout in health professionals who undergo training and deliver the Health Professional Therapy (HPT).
Identification of patient, health professional and systems barriers to implementation of systematic screening and delivery of psychosocial care through examination of Health Professional log books, semi-structured interviews with health professionals, analysis of recorded case review sessions, and documentation by the PRP regarding referral of severe cases are process outcomes.
This study aims to improve psychosocial care of patients with cancer through a systematic approach to identification of distress and risk, and delivery of a flexible psychosocial Intervention aligned explicitly with patient need.
This study uses innovative approaches to achieve an efficient, sustainable model of care which can be translated across diverse treatment settings: a brief tailored Intervention embedded in clinical care; more efficient use of limited and expensive specialist psychosocial services; an efficient use of the existing workforce through a multidisciplinary educational strategy, engagement of patients in self-care strategies, and a preventive element.
The design for this randomised study is a stepped wedge cluster design, a type of crossover design in which different clusters (the sites) cross-over in one direction only, from control to intervention.
The intervention is sequentially rolled-out across sites in random order over a number of time periods so that, at the conclusion of the study, all sites will have received training and be providing the intervention delivered by a recruited health professional (HP) who has received training at that site. Randomisation of sites will be undertaken by an independent statistician and investigators and sites will be informed after each site randomisation has occurred.
On activation of each site, health professionals will be recruited to participate in structured training conducted at their respective site, using a self-directed training manual, supplemented with skill development. The training will focus on three core therapeutic approaches: supportive/expressive; cognitive-behavioural, and dignity conserving.
Recruited patients will initially be screened with the Distress Thermometer (DT) and Psychosocial Checklist. Those with no distress (DT < 4) and no risk factors will be considered not to require more than usual care, and will not receive any intervention.
Patients screening positive on the DT (4 or more) or the Psychosocial Checklist will complete the HADS and be assigned as follows:
i. Patients with a HADS score of < 8 will receive a Patient Self-Directed Resource Suite only. This resource suite will include consumer resources demonstrated to be effective and acceptable, including the consumer version of the Psychosocial Clinical Practice Guidelines: Cancer, how are you travelling? as well as practical information about support groups, structured problem-solving and simple cognitive strategies, which the patient can employ to deal with concerns.
ii. Patients with a HADS score of 8-21 will receive a tailored Intervention delivered by a trained health professional. The intervention will consist of up to four health professional therapy (HPT) sessions, conducted face-to-face or by telephone, depending on mutual convenience of patient and the health professional. All HPT sessions will be no more than 30 minutes in length, conducted over a four-week period. This health professional will also participate in case review.
iii. Patients with a HADS score of 22 or more will be referred for specialist treatment via a pre-defined protocol developed at each site, implemented and recorded by the site research assistant.