Distress Thermometer Intervention Trial (DiTIT)

April 1, 2014 updated by: William Hollingworth, University Hospitals Bristol and Weston NHS Foundation Trust

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bristol, United Kingdom, BS2 8AE
        • University Hospitals Bristol
    • Somerset
      • Bath, Somerset, United Kingdom, BA1 3NG
        • Royal United Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Usual Care Arm
The usual care group will receive their Chemotherapy or Radiotherapy as normal.
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.
EXPERIMENTAL: DT&PL arm

During the second week of radiotherapy/second cycle of chemotherapy, patients in the Distress Thermometer and Problem List (DT&PL) arm of the study will complete the DT&PL (estimated 15 minutes to complete) with the trained radiographer/nurse.

The DT&PL assessment will be repeated at the end of therapy fractions/cycles. This will elicit concerns about post-therapy issues and facilitate continuity of care between the cancer team and primary care. Depending on the duration of therapy, therapists may choose to use the DT&PL at other points during patient care. A copy of the DT&PL will be stored in the medical record to track the frequency of use and to check that those assigned to usual care were not monitored with the DT&PL.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Profile of Mood States (POMS)
Time Frame: 1, 6, 12 months post randomisation
1, 6, 12 months post randomisation

Secondary Outcome Measures

Outcome Measure
Time Frame
EQ-5D
Time Frame: 1,6,12 months post randomisation
1,6,12 months post randomisation
European Organisation for Research and Treatment of Cancer (EORTC - QLQ 30) cancer-related quality of life measure
Time Frame: 1,6, 12 months post randomisation
1,6, 12 months post randomisation
Trent Patient Satisfaction Questionnaire
Time Frame: 1, 6 months post randomisation
1, 6 months post randomisation
Resource Use
Time Frame: 12 months post randomisation
12 months post randomisation
Mortality
Time Frame: 12 months post randomisation
12 months post randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: William Hollingworth, PhD, University of Bristol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (ESTIMATE)

August 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • ON/2007/2744
  • REC # 08/H0101/224
  • NIHR # PB-PG-0807-13387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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