The Cancer Pain and Unmet Needs Study

Cancer Clinical Trial

Official title:

A Prospective Longitudinal Survey Exploring the Unmet Needs of Cancer Patients in Pain.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01651910
• Other study ID #: EC/2012/73/FHMS
• Status: Terminated
• Start date: July 2012
• Est. completion date: February 2014

Study information

• Verified date: May 2023
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 162
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cancer Pain

Locations

Country	Name	City	State
United Kingdom	The Royal Surrey County Hospital NHS Foundation Trust	Guildford	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	Royal Surrey County Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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