CancerNCT01651910
The Cancer Pain and Unmet Needs Study
An observational study of Cancer, run by University of Surrey at 1 site in United Kingdom.
Trial summary
The aim of the following study is to identify if cancer patients in pain report unmet supportive care needs that are comparable to the general cancer population or if these unmet needs are exacerbated depending on whether their pain is controlled, uncontrolled or if the patients have intermittent breakthrough pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 162 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Feb 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from patients attending St Luke's Cancer Centre at the Royal Surrey County Hospital, Guildford, Surrey, UK. An audit is already being carried out at the centre, to determine the amount of patients who have pain. Patients who have pain who have completed the audit and are willing to take part in research will be screened for the trial. In order to ensure that sufficient numbers of patients in the trial have controlled pain, uncontrolled pain and breakthrough pain, when 104 participants have been recruited into one of these specific pain groups then people will no longer be approached who have that type of pain.
Who may be able to join
- Willing to take part in the study.
- Age ≥ 18.
- Able to give written informed consent.
- Able to complete study questionnaires, in conjunction with a researcher.
Who cannot join
- Cognitive impairment.
- Transient pain- if pain is not present for most of the time or does not require regular analgesia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, GU2 7XX
About this study
Official title: A Prospective Longitudinal Survey Exploring the Unmet Needs of Cancer Patients in Pain.
The aim of the following study is to identify if cancer patients in pain report unmet supportive care needs that are comparable to the general cancer population or if these unmet needs are exacerbated depending on whether their pain is controlled, uncontrolled or if the patients have intermittent breakthrough pain. 312 cancer patients, who have reported to have either controlled, uncontrolled or breakthrough pain, will complete a series of questionnaires at two time points. The primary outcome is to determine the prevalence of self-perceived unmet supportive care needs, as identified by the Supportive Care Needs Survey -Short Form (SCNS-SF), in people who have pain caused by their cancer or cancer treatment.
Hypothesis- Patients with pain caused by their cancer or cancer treatments will report unmet needs, which will increase if their pain is uncontrolled or if they have breakthrough pain.
Read more
Secondary Objectives-
- To establish if other confounding factors -such as age, gender, marital status, diagnosis, educational level and treatment, are significant predictors in the reporting of unmet needs of people with cancer or cancer treatment related pain.
- To establish if there are any other symptoms, identified by the Memorial Symptom Assessment Scale - Short Form (MSAS-SF), that are significant predictors in the reporting of unmet needs of people with cancer or cancer treatment related pain.
- To compare the prevalence and severity of self-perceived unmet supportive care needs between people who experience controlled pain, uncontrolled pain and breakthrough pain.
- To compare the prevalence and severity of unmet supportive care needs of people whose pain has become controlled or uncontrolled over a period of four weeks.
- To identify if there are any changes in the participants' symptoms, Eastern Cooperative Oncology Group (ECOG) performance score or treatment that could contribute to a change in the reporting unmet needs between time point one and two.
- To establish if there are any characteristics of breakthrough pain, such as the frequency or severity of pain episodes, that have an association with prevalence and the severity of the unmet supportive care needs reported by patients with breakthrough pain caused by their cancer or cancer related treatments. Factors will be identified by the Breakthrough pain Assessment Tool (BAT).
Read the detailed description
The study will build on a range of qualitative and quantitative literature which has identified the unmet supportive care needs of people with cancer. This research has already led to the development of several needs assessment tools that have been used clinically or for research purposes. This study is not trying to identify new needs, but investigate which of the unmet needs that have already been identified, within the literature, apply to cancer patients who are in pain. These needs include psychological needs, such as fears about the cancer spreading or for loved ones and health information needs.
- Conditions
- Cancer
- Keywords
- Cancer Pain, Breakthrough Pain, Unmet Needs, Supportive care needs
- Medical subject headings
- Neoplasms, Cancer Pain, Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controlled Pain | Participants who have controlled pain; requiring regular painkillers which are maintaining the pain as none - mild with no breakthrough pain episodes. | |
| Uncontrolled Pain | Participants who have uncontrolled pain; pain that is moderate to severe whether on painkillers or not | |
| Breakthrough pain | Participants who have breakthrough pain; pain that is controlled but the patient has episodes when the pain intermittently 'flares up'. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of self-perceived unmet needs - by the Supportive Care Needs Survey Short Form
Individual unmet needs will be scored between one and five, the summated scores within each of the five domains (psychological, health systems and information, physical and daily living, patient care and support and sexuality) of the SCNS
Measured: At study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2014
- Study completionFeb 2014
Why it stopped: Recruitment issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Surrey County Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alison L Buchanan, BSc, Principal investigator, University of Surrey, Royal Surrey County Hosptial NHS trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651910
- Sponsor's protocol ID
- EC/2012/73/FHMS
- Status last verified
- May 2023
- First submitted
- 25 Jul 2012
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Already shared data at an international conference and planning to submit at least one paper.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Survey Exploring the Unmet Needs of Cancer Patients in Pain.
- ClinicalTrials.gov ID
- NCT01651910
- Acronym / sponsor ID
- EC/2012/73/FHMS
- Conditions
- Cancer
- Keywords
- Cancer Pain, Breakthrough Pain, Unmet Needs, Supportive care needs
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment issues.
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Royal Surrey County Hospital NHS Foundation Trust
- Study start
- Jul 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Jul 2012 (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 aim of the following study is to identify if cancer patients in pain report unmet supportive care needs that are comparable to the general cancer population or if these unmet needs are exacerbated depending on whether their pain is controlled, uncontrolled or if the patients have intermittent breakthrough pain. 312 cancer patients, who have reported to have either controlled, uncontrolled or breakthrough pain, will complete a series of questionnaires at two time points. The primary outcome is to determine the prevalence of self-perceived unmet supportive care needs, as identified by the Supportive Care Needs Survey -Short Form (SCNS-SF), in people who have pain caused by their cancer or cancer treatment.
Hypothesis- Patients with pain caused by their cancer or cancer treatments will report unmet needs, which will increase if their pain is uncontrolled or if they have breakthrough pain.
Secondary Objectives-
- To establish if other confounding factors -such as age, gender, marital status, diagnosis, educational level and treatment, are significant predictors in the reporting of unmet needs of people with cancer or cancer treatment related pain.
- To establish if there are any other symptoms, identified by the Memorial Symptom Assessment Scale - Short Form (MSAS-SF), that are significant predictors in the reporting of unmet needs of people with cancer or cancer treatment related pain.
- To compare the prevalence and severity of self-perceived unmet supportive care needs between people who experience controlled pain, uncontrolled pain and breakthrough pain.
- To compare the prevalence and severity of unmet supportive care needs of people whose pain has become controlled or uncontrolled over a period of four weeks.
- To identify if there are any changes in the participants' symptoms, Eastern Cooperative Oncology Group (ECOG) performance score or treatment that could contribute to a change in the reporting unmet needs between time point one and two.
- To establish if there are any characteristics of breakthrough pain, such as the frequency or severity of pain episodes, that have an association with prevalence and the severity of the unmet supportive care needs reported by patients with breakthrough pain caused by their cancer or cancer related treatments. Factors will be identified by the Breakthrough pain Assessment Tool (BAT).
Detailed description
The study will build on a range of qualitative and quantitative literature which has identified the unmet supportive care needs of people with cancer. This research has already led to the development of several needs assessment tools that have been used clinically or for research purposes. This study is not trying to identify new needs, but investigate which of the unmet needs that have already been identified, within the literature, apply to cancer patients who are in pain. These needs include psychological needs, such as fears about the cancer spreading or for loved ones and health information needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controlled Pain | – | –Participants who have controlled pain; requiring regular painkillers which are maintaining the pain as none - mild with no breakthrough pain episodes. |
| Uncontrolled Pain | – | –Participants who have uncontrolled pain; pain that is moderate to severe whether on painkillers or not |
| Breakthrough pain | – | –Participants who have breakthrough pain; pain that is controlled but the patient has episodes when the pain intermittently 'flares up'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from patients attending St Luke's Cancer Centre at the Royal Surrey County Hospital, Guildford, Surrey, UK. An audit is already being carried out at the centre, to determine the amount of patients who have pain. Patients who have pain who have completed the audit and are willing to take part in research will be screened for the trial. In order to ensure that sufficient numbers of patients in the trial have controlled pain, uncontrolled pain and breakthrough pain, when 104 participants have been recruited into one of these specific pain groups then people will no longer be approached who have that type of pain.
Key inclusion criteria (4 listed)
- Willing to take part in the study.
- Age ≥ 18.
- Able to give written informed consent.
- Able to complete study questionnaires, in conjunction with a researcher.
Key exclusion criteria (2 listed)
- Cognitive impairment.
- Transient pain- if pain is not present for most of the time or does not require regular analgesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of self-perceived unmet needs - by the Supportive Care Needs Survey Short Form
Time frame: At study completion, an average of 1 year
Individual unmet needs will be scored between one and five, the summated scores within each of the five domains (psychological, health systems and information, physical and daily living, patient care and support and sexuality) of the SCNS
Results and safety
The study was stopped early (reason given: Recruitment issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Yes. Already shared data at an international conference and planning to submit at least one paper.
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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.
Alison L Buchanan, BSc principal investigator
University of Surrey, Royal Surrey County Hosptial NHS trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Surrey at 1 site 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 2 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: stopped early, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: Recruitment issues.). Results are not available in the source record.
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?
Identification of self-perceived unmet needs - by the Supportive Care Needs Survey Short Form (time frame: At study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2023.