The Cancer Pain and Unmet Needs Study

NCT01651910 | Terminated

• 1 other identifier: EC/2012/73/FHMS
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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. 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. 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. 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).

Conditions

Cancer

Keywords

Cancer Pain; Breakthrough Pain; Unmet Needs; Supportive care needs

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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'.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Surrey: lead
• Royal Surrey County Hospital NHS Foundation Trust: collaborator

Study Sites (1)

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, GU2 7XX, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Cancer Pain; Breakthrough Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alison L Buchanan, BSc

  University of Surrey, Royal Surrey County Hosptial NHS trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)