Clinical trial NCT00960466: Distress Thermometer Intervention Trial
Official title: Evaluating the Effect of Monitoring Cancer Patients Using the Distress Thermometer on Levels of Distress and Health Service Costs - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: Stress, Psychological
Neoplasms/psychology
Psychology
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Royal United Hospital Bath NHS Trust
name: University of Bristol
First posted: 2009-08-17
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Profile of Mood States (POMS)
timeFrame: 1, 6, 12 months post randomisation
Secondary outcomes:
measure: EQ-5D
timeFrame: 1,6,12 months post randomisation
measure: European Organisation for Research and Treatment of Cancer (EORTC - QLQ 30) cancer-related quality of life measure
timeFrame: 1,6, 12 months post randomisation
measure: Trent Patient Satisfaction Questionnaire
timeFrame: 1, 6 months post randomisation
measure: Resource Use
timeFrame: 12 months post randomisation
measure: Mortality
timeFrame: 12 months post randomisation
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: Somerset
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol
Study officials:
affiliation: University of Bristol
name: William Hollingworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brennan J, Gingell P, Brant H, Hollingworth W. Refinement of the distress management problem list as the basis for a holistic therapeutic conversation among UK patients with cancer. Psychooncology. 2012 Dec;21(12):1346-56. doi: 10.1002/pon.2045. Epub 2011 Sep 9.
citation: Hollingworth W, Metcalfe C, Mancero S, Harris S, Campbell R, Biddle L, McKell-Redwood D, Brennan J. Are needs assessments cost effective in reducing distress among patients with cancer? A randomized controlled trial using the Distress Thermometer and Problem List. J Clin Oncol. 2013 Oct 10;31(29):3631-8. doi: 10.1200/JCO.2012.48.3040. Epub 2013 Sep 3.