The Pain and Unmet Needs Study
|ClinicalTrials.gov Identifier: NCT01651910|
Recruitment Status : Terminated (Recruitment issues, interim analysis indicated a reduced sample size of 162 was acceptable.)
First Posted : July 27, 2012
Last Update Posted : April 10, 2014
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.
- 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).
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||162 participants|
|Official Title:||A Prospective Longitudinal Survey Exploring the Unmet Needs of Cancer Patients in Pain.|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||February 2014|
Participants who have controlled pain; requiring regular painkillers which are maintaining the pain as none - mild with no breakthrough pain episodes.
Participants who have uncontrolled pain; pain that is moderate to severe whether on painkillers or not
Participants who have breakthrough pain; pain that is controlled but the patient has episodes when the pain intermittently 'flares up'.
- Identification of self-perceived unmet needs - by the Supportive Care Needs Survey Short Form [ Time Frame: Needs will be calculated at time point one. ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651910
|The Royal Surrey County Hospital NHS Foundation Trust|
|Guildford, Surrey, United Kingdom, GU2 7XX|
|Principal Investigator:||Alison L Buchanan, BSc||University of Surrey, Royal Surrey County Hosptial NHS trust|