Condition category
Cancer
Date applied
30/09/2015
Date assigned
30/09/2015
Last edited
20/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lucy Ziegler

ORCID ID

Contact details

Cancer Research UK
Psychosocial Oncology and Clinical Practice Research Group
Beckett Street
Leeds
LS9 7TF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19024

Study information

Scientific title

Improving the Management of Pain from Advanced Cancer in the CommuniTy Feasibility Randomised Controlled Trial

Acronym

IMPACCT

Study hypothesis

Within oncology services, early screening and referral of community based patients with pain from advanced cancer, combined with routine pain assessment and monitoring, will reduce the extent of pain and psychological distress reported by the patient.

Ethics approval

15/YH/0235

Study design

Randomised; Interventional; Design type: Process of Care, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cancer; Subtopic: Colorectal Cancer, Upper Gastro-Intestinal Cancer, Breast Cancer, Lung Cancer, Prostate Cancer; Disease: Breast, Colon, Lung (non-small cell), Prostate

Intervention

160 participants will be recruited, and randomly allocated on an equal basis to receive either the intervention or usual care or standard care. Participants allocated to the intervention will be referred to their local palliative care team and further intervention will take place within the palliative care setting. The participants will be asked to complete a questionnaire pack at baseline when they enter the study, at 6 weeks and then at 12 weeks after this date. This will be completed in clinic at the baseline visit and sent to their home address at the 6 and 12 week visits. A Researcher (who will be blind to treatment allocation) from the University of Leeds will call the participant and offer to go through the answers to the questionnaires if they prefer.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Uptake and retention rate of each intervention recorded throughout the study period
2. Pain severity measured using the Brief Pain Inventory at 6 and 12 weeks

Secondary outcome measures

N/A

Overall trial start date

01/10/2015

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 years or over
2. Diagnosis of advanced incurable disease (locally advanced or metastatic) in one of the following disease areas:
2.1. Breast
2.2. Colon or Rectal
2.3. Non-Small Cell Lung Cancer
2.4. Prostate
2.5. Upper GI
3. Experiencing cancer related pain (tumour or treatment related) (as assessed by the Clinician) with an average pain score of = 4 on the “average pain” item of the Brief Pain Inventory
4. Has the potential to benefit from palliative care support as assessed by the Clinician.
5. An expected prognosis of 12 weeks or more
6. The patient is living at home
7. The patient lives in the local catchment area for a participating hospice
8. The patient is able and willing to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 160; UK Sample Size: 160

Participant exclusion criteria

1. Previously referred to palliative care team.
2. The patient has insufficient literacy, or proficiency in English to contribute to the data collection required for the research
3. Patients will be excluded if they lack capacity to provide informed consent to this trial
4. Patients with dominant chronic pain that is not cancer related (tumour or treatment)

Recruitment start date

01/10/2015

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychosocial Oncology and Clinical Practice Research Group
Beckett Street
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

School of Healthcare
Baines Wing
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/09/2016: Internal review.