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Evaluating the Effect of Monitoring Cancer Patients Using the Distress Thermometer on Levels of Distress and Health Service Costs - a Randomised Controlled Trial

Phase 3
18 Years
85 Years
Not Enrolling

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Trial Information

Evaluating the Effect of Monitoring Cancer Patients Using the Distress Thermometer on Levels of Distress and Health Service Costs - a Randomised Controlled Trial

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

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.

Inclusion Criteria:

- Primary solid tumour diagnosis within the last 12 months

- Scheduled for outpatient external RT fractions over a period of at least 2 weeks or
scheduled outpatient CT regimen over 2 or more cycles

- Patient aged >= 18 and <85 years

- Ability to read and communicate in English (personally or via translator)

Exclusion Criteria:

- Receiving neoadjuvant CT

- Patient declines consent

- Clinical presentation dictates treatment by a specific therapist not trained in use
of the Distress Thermometer

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Profile of Mood States (POMS)

Outcome Time Frame:

1, 6, 12 months post randomisation

Safety Issue:


Principal Investigator

William Hollingworth, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Bristol


United Kingdom: National Health Service

Study ID:




Start Date:

October 2009

Completion Date:

March 2012

Related Keywords:

  • Cancer
  • Stress, Psychological
  • Neoplasms/psychology
  • Psychology