Clinical trial · Interventional
Distress Thermometer Intervention Trial
Evaluating the Effect of Monitoring Cancer Patients Using the Distress Thermometer on Levels of Distress and Health Service Costs - a Randomised Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Distress Thermometer and Problems List | Behavioral | — | UNRESOLVED |
| Usual psychosocial support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Usual Care Arm
- description
- The usual care group will receive their Chemotherapy or Radiotherapy as normal.
- interventionNames
- Behavioral: Usual psychosocial support
- type
- EXPERIMENTAL
- label
- DT&PL arm
- description
- 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.
- interventionNames
- Behavioral: Distress Thermometer and Problems List
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDBrennan 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. PMID 21905157
- RESULTHollingworth 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. PMID 24002506