a) Training of health professionals who will deliver the psychosocial Intervention
b) Delivery of the psychosocial Intervention by the trained health professionals.
The design for this randomised study is a stepped-wedge cluster design, a type of crossover design in which different clusters (the clinical sites) cross over in one direction only, from Control to Training then Intervention [
28]. At the conclusion of the study, all sites will have received Training and be providing the Intervention [
29] delivered by health professionals who have received training at that site as depicted in Table
1.
Table 1
Stepped wedge design.
Site 1 | Control | TRAINING |
Intervention
|
Intervention
|
Intervention
|
Intervention
|
Intervention
|
Site 2 | Control | Control | TRAINING |
Intervention
|
Intervention
|
Intervention
|
Intervention
|
Site 3 | Control | Control | Control | TRAINING |
Intervention
|
Intervention
|
Intervention
|
Site 4 | Control | Control | Control | Control | TRAINING |
Intervention
|
Intervention
|
Site 5 | Control | Control | Control | Control | Control | TRAINING |
Intervention
|
Week | 1 | 10 | 20 | 30 | 40 | 50 | 60 |
The nature of the Intervention will be
tailored to the level of need of the patient, eligible patients receiving a "low-intensity" or "medium-intensity" Intervention, allocated according to the Algorithm depicted in Table
2.
Table 2
Algorithm for patient allocation to Intervention
No risk factors | + risk factors2
HADS3 < 8 | +/- risk factors2
HADS3 < 8 | +/- risk factors2
HADS3 8-21 | +/- risk factors2
HADS3 22 or greater |
Usual care |
Low-intensity Intervention
Patient self-directed resource suite only |
Medium-
intensity
Intervention
Tailored psychosocial Intervention delivered by trained Health Professional | Specialised Treatment with an appropriately qualified practitioner via a pre-defined clinical pathway |
i) Low-intensity Intervention
Patients who have a Hospital Anxiety and Depression Scale (HADS) [
30] score of less than 8,
in addition to
either the presence of risk factors or current distress (DT score 4 or greater) will receive the low-intensity Intervention. This consists of a suite of consumer resources demonstrated to be effective and acceptable, including the consumer version of the Clinical Practice Guidelines for the Psychosocial Care of Adults with Cancer:
Cancer, how are you travelling? [
31]. The resource suite will include practical information about support groups and describe structured problem-solving and simple cognitive strategies, which can be employed to deal with concerns. Engagement of patients through educational and other resources has been demonstrated to be effective in collaborative care models [
32] with the potential for patients to develop self-care and other strategies sustained beyond the duration of the Intervention. Engagement of patients in self-care strategies is strongly endorsed by consumer advisors to this study. In addition it has inherent appeal in terms of cost and potential to be delivered in diverse settings.
ii) Medium-intensity Intervention
Patients who have a HADS score of 8-21 inclusive will receive the medium-intensity Intervention, irrespective of the presence or absence of risk factors Simple provision of information alone has been demonstrated to be insufficient to treat depressed patients [
33], meaning that a more intensive Intervention is required for depressed patients [
34]. The medium-intensity Intervention consists of up to 4 tailored sessions, delivered by a health professional who has participated in specific training in order to be skilled to deliver the Intervention. These sessions will be conducted face-to-face or by telephone, depending on mutual convenience of patient and the health professional. All medium-intensity Intervention sessions will be up to 30 minutes in duration, conducted over a 4-week period. The duration of this Intervention reflects clinical practice with brief therapy, and represents a feasible time commitment for the health professional.
All medium-intensity Intervention sessions will have the following core principles:
• Focus on engagement with the patient
• Eliciting and exploring key patient concerns
• Establishment of an agreed treatment plan with the patient, focusing on strategies to address Distress. This treatment plan will be developed in consultation with the patient after review of their self-report on the Distress Thermometer as above. The treatment plan will incorporate detailed assessment and referral for further assistance as necessary, for example with practical concerns, financial issues, or physical symptoms such as pain or nausea. The need for referral will depend on the background training of the health professional delivering the Intervention - for example, a nurse will often be able to assess and initiate symptom management whilst a radiation therapist would refer the patient to a doctor or nurse.
• Regular review of this plan and its progress through the process of Clinical Case Review (clinical supervision).
The medium-intensity Intervention has been designed to ensure flexibility to select the most appropriate strategies to assist each patient,
based on the patient's self-reported areas of concern as identified on the Distress Thermometer. During their training health professionals will acquire the necessary skills to critically analyse the nature of the patient's concerns and devise a tailored Intervention specific to the patient's needs. Examples of specific techniques which may be used by the health professional in the medium-intensity Intervention depending on patient need are provided in Table
3.
Table 3
Examples of strategies to address patient distress
Practical - finances; difficulty with domestic tasks | Referral to Social Work; clarification of concerns; structured problem-solving; challenging black and white thinking about the need to perform domestic tasks; re-assigning priorities. |
Family - concerns about children | Listening; acknowledgment of concerns; explanation about children's needs; discussion about the benefits of maintaining routine; reassuring children that they have not caused the cancer. |
Emotional - anxiety about chemotherapy | Explanation; identification of automatic thoughts; challenging negative cognitions; relaxation and guided imagery. |
Physical - pain | Referral for medical review; exploration of concerns about pain; identifying and challenging misbeliefs e.g. about becoming dependent on analgesia or that use of morphine implies inevitably poor prognosis; relaxation and guided imagery. |
Spiritual - shame about dependence, low sense of worth | Dignity-conserving techniques e.g. exploration of past experiences, reflection on strengths; engaging in creative discussion about ways to feel in control; framing assistance as necessary to maintain dignity. |
All health professionals delivering the medium-intensity Intervention will participate in Clinical Case Review (clinical supervision) facilitated by an experienced consultation-liaison psychiatrist. Sessions will be conducted in group format on a weekly basis. Health professionals will use these sessions to discuss the patients for whom they have delivered the medium-intensity Intervention, including discussion of specific components of the Intervention, difficulties encountered by the health professional, and be assisted to devise strategies to respond. A pre-determined structure will be followed to ensure consistency of Clinical Case Review across sites.
The health professional will record details of each session in a structured logbook noting precise details of all Intervention contacts with each patient including date, duration, mode (face-to-face or telephone), themes discussed and referrals such as to physiotherapy, or medical review of pain.