The Cancer Pain and Unmet Needs Study

NCT ID: NCT01651910

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 162 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-02-28

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. 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).

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Controlled Pain

Participants who have controlled pain; requiring regular painkillers which are maintaining the pain as none - mild with no breakthrough pain episodes.

No interventions assigned to this group

Uncontrolled Pain

Participants who have uncontrolled pain; pain that is moderate to severe whether on painkillers or not

No interventions assigned to this group

Breakthrough pain

Participants who have breakthrough pain; pain that is controlled but the patient has episodes when the pain intermittently 'flares up'.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Surrey County Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Surrey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison L Buchanan, BSc

Role: PRINCIPAL_INVESTIGATOR

University of Surrey, Royal Surrey County Hosptial NHS trust

Locations

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

EC/2012/73/FHMS

Identifier Type: -

Identifier Source: org_study_id