Distress Thermometer Intervention Trial

NCT00960466 | Completed Phase 3

• 3 other identifiers: ON/2007/2744REC # 08/H0101/224NIHR # PB-PG-0807-13387
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

Stress, Psychological; Neoplasms/psychology; Psychology

Outcome Measures

Primary Outcomes (1)

• Profile of Mood States (POMS)

  1, 6, 12 months post randomisation

Secondary Outcomes (5)

• EQ-5D

  1,6,12 months post randomisation

• European Organisation for Research and Treatment of Cancer (EORTC - QLQ 30) cancer-related quality of life measure

  1,6, 12 months post randomisation

• Trent Patient Satisfaction Questionnaire

  1, 6 months post randomisation

• Resource Use

  12 months post randomisation

• Mortality

  12 months post randomisation

Study Arms (2)

Usual Care Arm

ACTIVE COMPARATOR

The usual care group will receive their Chemotherapy or Radiotherapy as normal.

Behavioral: Usual psychosocial support

DT&PL arm

EXPERIMENTAL

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.

Behavioral: Distress Thermometer and Problems List

Interventions

Distress Thermometer and Problems List BEHAVIORAL

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.

DT&PL arm

Usual psychosocial support BEHAVIORAL

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.

Usual Care Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Receiving neoadjuvant CT
• Patient declines consent
• Clinical presentation dictates treatment by a specific therapist not trained in use of the Distress Thermometer

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead
• Royal United Hospital Bath NHS Trust: collaborator
• University of Bristol: collaborator

Study Sites (2)

Royal United Hospital

Bath, Somerset, BA1 3NG, United Kingdom

Location

University Hospitals Bristol

Bristol, BS2 8AE, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 21905157 BACKGROUND

• 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.

  PMID: 24002506 RESULT

MeSH Terms

Conditions

Neoplasms; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• William Hollingworth, PhD

  University of Bristol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader, School of Social and Community Medicine

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 2, 2014

Record last verified: 2014-04

Locations

GB (2)