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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02341846
Other study ID # 2/069/14
Secondary ID
Status Completed
Phase N/A
First received January 14, 2015
Last updated January 20, 2016
Start date February 2015
Est. completion date August 2015

Study information

Verified date November 2015
Source University of Aberdeen
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

This interview and focus group study will explore patient, caregiver, and health professional opinions about the potential roles of digital technology to support effective cancer pain management. The views, opinions, and ideas expressed in this study will be used to design and develop a digital intervention which is likely to take the form of a measurement (pain and analgesic use) guided medication management intervention to improve cancer pain management in the community.


Description:

Cancer is increasing in incidence and prevalence in the United Kingdom. Pain is the most frequent complication of cancer and cancer pain control is frequently suboptimal. Previous research has established several potentially modifiable reasons for suboptimal cancer pain management. These include: under-reporting of pain; inadequate communication about pain between patients and health care professionals ; inadequate assessment of pain by health care providers; inadequate analgesic prescribing; suboptimal adherence to prescribed analgesic regimens by patients; and failure to re-assess pain timeously.

Information and communication technology (ICT) is a term used to describe all digital technologies that facilitate the electronic capture, processing, storage, and exchange of information. ICT could offer innovative solutions to suboptimal cancer pain management. Technological solutions might include electronic diaries, available as applications or "apps", which could encourage pain self-monitoring by people with cancer, and prompt medical assessment when pain is poorly controlled. Accurate patient reported pain data could help professionals to adequately assess pain and might influence the patient-professional consultation. Feedback of adherence data to patients and carers might improve the way that medications are used. Electronic medication adherence devices are currently available which can capture data on analgesic utilisation and timing. This data might be useful for health care professionals to inform safe and timely adjustments of analgesic doses (i.e. is pain control poor because of inadequate analgesic dose or because of non-adherence to the prescribed regime?). The aim of the proposed study is to explore the desirability, feasibility, and practicalities of using ICT to improve cancer pain management The proposed study would seek the views of patients with cancer pain, their caregivers, and health care professionals, about using technology to help with cancer pain management. The study will investigate the acceptability of electronic pain diaries and electronic medication adherence devices to patients and health care professionals, barriers to using such technology, and how data generated from technology might be used by patients, caregivers, and health care professionals to improve cancer pain management. This study will form part of a programme of research and data from the proposed study will be used to inform the potential development of a technological intervention to improve the management of cancer pain in the community.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients

- Adults, 18 years of age or over.

- Established diagnosis of any cancer type.

- Have experienced pain related to cancer or its treatment requiring any form of analgesic within the last three months.

- Patients with all stages and grades of cancer who feel that they are willing and able to participate in an interview.

Caregivers • Caregivers aged 18 years of age or over who are or have been involved in providing care or assistance for somebody who has experienced cancer pain. Examples of caregivers might include family members, spouse, and close friends, who provide care and assistance to patients with cancer pain.

Professionals

• Registered doctors, nurses, and pharmacists who provide care for people with cancer pain.

Exclusion Criteria:

- • Non- English language speakers. Qualitative investigations will be reliant on communication in English. Specific words and phrases will be analysed by English speaking researchers in order to identify thematic content. This study does not include resources for interpreting services.

- Patients who are thought to have entered the terminal stages of their illness will be excluded. This will be judged at recruitment by the screening clinician from the patient's general practice. In the case that a recruited patient has become too ill to participate in the research or has died before participation, and a linked caregiver has expressed interest in the study, the caregiver will be contacted, offered sympathies, and will be given the opportunity to withdraw from the study or continue as planned. All conversations about the study will be conducted in a supportive manner that recognises the sensitivity of the subject matter.

- Patients who are registered at Great Western Medical Practice, Aberdeen (Rosalind Adam, researcher and interviewer practices as a doctor there).

- Any participant who declines to take part.

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Other:
Qualitative interviews


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Aberdeen Chief Scientist Office of the Scottish Government

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative semi-structured interviews Eight months No
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