The Pain and Unmet Needs Study

This study has been terminated.

(Recruitment issues, interim analysis indicated a reduced sample size of 162 was acceptable.)

Sponsor:

Collaborator:

Royal Surrey County Hospital NHS Foundation Trust

Information provided by (Responsible Party):

University of Surrey

ClinicalTrials.gov Identifier:

NCT01651910

First received: July 25, 2012

Last updated: April 9, 2014

Last verified: November 2012

History of Changes

Purpose

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).

Condition
Cancer


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Prospective Longitudinal Survey Exploring the Unmet Needs of Cancer Patients in Pain.

Further study details as provided by University of Surrey:

Primary Outcome Measures:

Identification of self-perceived unmet needs - by the Supportive Care Needs Survey Short Form [ Time Frame: Needs will be calculated at time point one. ] [ Designated as safety issue: No ]
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


Enrollment:	162
Study Start Date:	July 2012
Study Completion Date:	February 2014
Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
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'.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Cognitive impairment.
Transient pain- if pain is not present for most of the time or does not require regular analgesia

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651910

Locations


United Kingdom
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, United Kingdom, GU2 7XX

Sponsors and Collaborators

University of Surrey

Royal Surrey County Hospital NHS Foundation Trust

Investigators


Principal Investigator:	Alison L Buchanan, BSc	University of Surrey, Royal Surrey County Hosptial NHS trust

More Information


Responsible Party:	University of Surrey
ClinicalTrials.gov Identifier:	NCT01651910 History of Changes
Other Study ID Numbers:	EC/2012/73/FHMS
Study First Received:	July 25, 2012
Last Updated:	April 9, 2014
Health Authority:	United Kingdom: National Health Service United Kingdom: Research Ethics Committee

Keywords provided by University of Surrey:


Cancer Pain Breakthrough Pain Unmet Needs Supportive care needs

ClinicalTrials.gov processed this record on September 30, 2016

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