CancerPhase 3DiTITNCT00960466
Distress Thermometer Intervention Trial
A Phase 3 study testing Distress Thermometer and Problems List and Usual psychosocial support in people with Cancer, run by University Hospitals Bristol and Weston NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer
- What is being tested?
- Distress Thermometer and Problems List and Usual psychosocial support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2009to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Receiving neoadjuvant CT
- Patient declines consent
- Clinical presentation dictates treatment by a specific therapist not trained in use of the Distress Thermometer
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal United Hospital
Bath, Somerset, BA1 3NG
University Hospitals Bristol
Bristol, BS2 8AE
About this study
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
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Distress Thermometer and Problems List, Usual psychosocial support
- Keywords
- Stress, Psychological, Neoplasms/psychology, Psychology
- Medical subject headings
- Neoplasms, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distress Thermometer and Problems ListBehavioural
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.
Usual psychosocial supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Arm | Active comparator | The usual care group will receive their Chemotherapy or Radiotherapy as normal. Receives: 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. Receives: Behavioral: Distress Thermometer and Problems List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Mood States (POMS)
Measured: 1, 6, 12 months post randomisation
Secondary outcomes (5)
EQ-5D
Measured: 1,6,12 months post randomisation
European Organisation for Research and Treatment of Cancer (EORTC - QLQ 30) cancer-related quality of life measure
Measured: 1,6, 12 months post randomisation
Trent Patient Satisfaction Questionnaire
Measured: 1, 6 months post randomisation
Resource Use
Measured: 12 months post randomisation
Mortality
Measured: 12 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal United Hospital Bath NHS Trust, University of Bristol
- Responsible party
- Principal investigator, William Hollingworth, University Hospitals Bristol and Weston NHS Foundation Trust
- Investigators
- William Hollingworth, PhD, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960466
- Sponsor's protocol ID
- ON/2007/2744
- Other IDs
- REC # 08/H0101/224, NIHR # PB-PG-0807-13387
- Acronym
- DiTIT
- Status last verified
- Apr 2014
- First submitted
- 14 Aug 2009
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21905157Hollingworth 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.
PubMed 24002506
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00960466
- Acronym / sponsor ID
- DiTIT / ON/2007/2744
- Conditions
- Cancer
- Keywords
- Stress, Psychological, Neoplasms/psychology, Psychology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal United Hospital Bath NHS Trust, University of Bristol
- Study start
- Oct 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Arm | Active comparator | Behavioral: Usual psychosocial supportThe usual care group will receive their Chemotherapy or Radiotherapy as normal. |
| DT&PL arm | Experimental | Behavioral: Distress Thermometer and Problems ListDuring 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Receiving neoadjuvant CT
- Patient declines consent
- Clinical presentation dictates treatment by a specific therapist not trained in use of the Distress Thermometer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distress Thermometer and Problems ListWhen 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. | Behavioural | DT&PL arm |
| Usual psychosocial supportIf 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. | Behavioural | Usual Care Arm |
Primary outcome
Profile of Mood States (POMS)
Time frame: 1, 6, 12 months post randomisation
5 secondary outcomes
EQ-5D
Time frame: 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
Trent Patient Satisfaction Questionnaire
Time frame: 1, 6 months post randomisation
Resource Use
Time frame: 12 months post randomisation
Mortality
Time frame: 12 months post randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Background: PubMed 21905157Brennan 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.
- Results publication: PubMed 24002506Hollingworth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Hollingworth, PhD principal investigator
University of Bristol
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Distress Thermometer and Problems List and Usual psychosocial support in people with Cancer, run by University Hospitals Bristol and Weston NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of Mood States (POMS) (time frame: 1, 6, 12 months post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00960466, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.