Distress Thermometer Intervention Trial
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.
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Conditions
Cancer
Intervention
Distress Thermometer and Problems List, Usual psychosocial support
Location
Royal United Hospital
Bath
Somerset
United Kingdom
BA1 3NG
Status
Recruiting
Source
University Hospitals Bristol NHS Trust
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00960466
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:19:57-0400
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Medical and Biotech [MESH] Definitions
Psychosocial Support Systems
Organized efforts to address ongoing psychological and social problems of individuals, their partners, families and caregivers.
Medical Records, Problem-oriented
A system of record keeping in which a list of the patient's problems is made and all history, physical findings, laboratory data, etc. pertinent to each problem are placed under that heading.
International Classification Of Functioning, Disability And Heal...
The World Health Organization's classification categories of health and health-related domains. The International Classification of Functioning, Disability and Health (ICF) consists of two lists: a list of body functions and structure, and a list of domains of activity and participation. The ICF also includes a list of environmental factors.
Potentially Inappropriate Medication List
A list, criteria, or screening tool designed to improve PATIENT SAFETY by determining an individual's exposure to potentially inappropriate drugs. They are designed to prevent MEDICATION ERRORS by INAPPROPRIATE PRESCRIBING. Analysis for a list includes factors such as DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; AGE FACTORS; GENDER; and existing medical conditions.
Karnofsky Performance Status
A performance measure for rating the ability of a person to perform usual activities, evaluating a patient's progress after a therapeutic procedure, and determining a patient's suitability for therapy. It is used most commonly in the prognosis of cancer therapy, usually after chemotherapy and customarily administered before and after therapy. It was named for Dr. David A. Karnofsky, an American specialist in cancer chemotherapy.
