Distress Thermometer Intervention Trial
Condition: Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      The diagnosis and treatment of cancer has been shown to lead to very high levels of distress
      among patients. Although treatments for a range of different cancers have become much better
      in recent years, the distress that accompanies diagnosis and treatment can have serious
      negative effects for patients. Research has shown that, for a number of reasons, patients
      find it difficult to inform healthcare professionals about the cause of their distress
      whether it is physical (e.g. pain), psychological (anxiety and depression), personal partners
      and family) or social (finances). Also, medical staff often fail to detect even high levels
      of distress. This means that a great deal of distress is not being treated and this may lead
      to more hospital and GP visits, and dissatisfaction with care. The Distress Thermometer and
      Problem List (DT&PL) is a simple method of identifying distress in cancer patients using the
      familiar image of a thermometer. It offers patients a list of common treatment-related
      difficulties to help them identify any problems that cause distress. A trained staff member
      uses the DT&PL to discuss with the patient different options for addressing each concern:
      directly where possible (action taken by the patient or the staff member present) or leading
      to a referral to a specialist where necessary. Our research aims to measure whether the DT&PL
      is effective in quickly identifying and treating cancer-related distress and therefore
      preventing longer-term problems developing. The investigators also want to know whether
      patients find it helpful to complete the DT&PL and whether using the DT&PL saves NHS time and
      money.
    

Detailed description: 
      BACKGROUND: Systematic psychological assessment and appropriate psychological support is a
      key aim of NICE guidance for supportive and palliative cancer care. Cancer causes high levels
      of distress during diagnosis, treatment and beyond. 'Distress' is a psychological state that
      may be fuelled by physical (e.g. pain), interpersonal (family tensions), psychological
      (anxiety and depression), social (finances), and existential concerns. Often these concerns
      are not expressed by patients or identified by healthcare staff. Our pilot work suggests that
      the Distress Thermometer and Problem List (DT&PL) is a tool that healthcare staff can use to
      efficiently identify and address these holistic needs. Use of the DT&PL could reduce both
      patient distress and the NHS costs of treating the sequelae of distress.

      AIMS: To demonstrate the feasibility of performing a randomised controlled trial (RCT) in 3
      cancer therapy units and to provide data for the design of a future trial in larger numbers
      of radiotherapy and chemotherapy units. To compare use of the Distress Thermometer and
      Problem List (DT&PL) with usual care and document differences in patients' psychological
      well-being and health-related quality of life. To assess the cost-effectiveness to the NHS
      and society of using the DT&PL in routine clinical practice. To assess patient and staff
      attitudes to completing the DT&PL and identify any perceived gaps in local psychosocial
      supportive services.

      METHODS: A RCT to compare usual psychosocial care with usual care plus DT&PL administered by
      trained radiographers and nurses for cancer patients receiving chemotherapy or radiotherapy.
      The DT&PL will be used during and at the end of chemo/radiotherapy. Baseline questionnaires
      include Profile of Mood States (POMS - primary outcome), European Organisation for Research
      and Treatment of Cancer (EORTC) cancer-related quality of life measure and EQ-5D utility
      score. Qualitative interviews will explore patient, carer and staff views on the DT&PL and
      other aspects of supportive care. Patient follow up will occur at 1, 6 and 12 months to
      determine whether the intervention improves psychological well-being and health related
      quality of life and the impact on NHS and broader societal costs.
    

Intervention name(s): Distress Thermometer and Problems List; Usual psychosocial support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): When using the distress thermometer and problem list (DT&PL), the nurse or radiographer asks the patient to indicate distress over the past week on a visual analogue scale from 0 (no distress) to 10 (high distress). Next, from a list of 42 items, patients identify practical, family, emotional, spiritual or physical problems that have caused distress. The completion of the DT&PL should be a collaborative exercise with patients able to review what is written on the assessment sheet. Potential solutions will be discussed which may involve the following: i) concerns that can be resolved immediately (e.g. providing information, prescribing an analgesic); ii) concerns that require patient actions (e.g. participating in support groups); iii) concerns that require a referral (e.g. mental health specialist, social or pastoral care). The meeting will end with a summary plan of action.; If patients express concerns about psychosocial issues, then clinic staff will discuss these issues, offer advice or make a referral as they see fit. However, no formal time will be set aside to monitor patient distress using the DT, elicit problems using the PL or develop a plan of action based on these tools. Because of the nature of the intervention, both the patient and the therapist will be aware of treatment assignment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Stress, Psychological; Neoplasms/psychology; Psychology