The Cancer Pain and Unmet Needs Study

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.

Secondary Objectives-

1. 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.
2. 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.
3. To compare the prevalence and severity of self-perceived unmet supportive care needs between people who experience controlled pain, uncontrolled pain and breakthrough pain.
4. 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.
5. 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.
6. 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).

Study Overview

• Status: Terminated
• Conditions: Cancer

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 Type: Observational
• Enrollment (Actual): 162

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Surrey
• Collaborators: Royal Surrey County Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Alison L Buchanan, BSc, University of Surrey, Royal Surrey County Hosptial NHS trust

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimated): July 27, 2012

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Cancer Pain; Supportive care needs; Breakthrough Pain; Unmet Needs
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: EC/2012/73/FHMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Already shared data at an international conference and planning to submit at least one paper.