Improving the management of pain from advanced cancer in the community
| ISRCTN | ISRCTN18281271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18281271 |
| Secondary identifying numbers | 19024 |
- Submission date
- 30/09/2015
- Registration date
- 30/09/2015
- Last edited
- 12/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Lucy Ziegler
Scientific
Scientific
Cancer Research UK
Psychosocial Oncology and Clinical Practice Research Group
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Process of Care, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Improving the management of pain from advanced cancer in the community: a feasibility randomised controlled trial |
| Study acronym | IMPACCT |
| Study objectives | 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(s) | 15/YH/0235 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 | No secondary outcome measures |
| Overall study start date | 01/10/2015 |
| Completion date | 04/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 161; UK Sample Size: 161 |
| Total final enrolment | 161 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 26/01/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cancer Research UK
Beckett Street
Leeds
LS9 7TF
United Kingdom
Leeds
LS9 7TF
United Kingdom
Sponsor information
University of Leeds
Hospital/treatment centre
Hospital/treatment centre
School of Healthcare
Baines Wing
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
"ROR" |
https://ror.org/024mrxd33 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/03/2018 | Yes | No | |
| Results article | 01/12/2021 | 13/07/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
12/09/2022: Internal review.
13/07/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
16/04/2018: The overall trial end date was changed from 30/04/2018 to 04/04/2018.
27/03/2018: Publication reference added.
07/02/2018: The following changes were made:
1. Recruitment end date was changed from 28/02/2018 to 26/01/2018.
2. Overall trial end date was changed from 31/05/2018 to 30/04/2018.
3. Number of participants was changed from 160 to 161.
04/08/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2016 to 28/02/2018.
2. The overall trial end date was changed from 30/09/2016 to 31/05/2018.
30/05/2017: Cancer Help UK lay summary link added to plain English summary field.
