Evaluation of a palliative day care service for cancer survivors
| ISRCTN | ISRCTN22485853 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22485853 |
| Secondary identifying numbers | 09/H0714/46 |
- Submission date
- 21/09/2009
- Registration date
- 09/11/2009
- Last edited
- 27/11/2015
- 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
Not provided at time of registration
Contact information
Dr Louise Jones
Scientific
Scientific
Department Mental Health Sciences
Royal Free Hospital
Rowland Hill Street
London
NW3 2PF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial to evaluate a complex rehabilitative intervention for patients with advanced progressive recurrent cancer |
| Study objectives | The project aim is to assess whether a complex rehabilitative intervention, delivered in a voluntary sector hospice at the end of a course of treatment for recurrent cancer not considered to have been cured, offers a high value, cost-effective approach to care that is acceptable to patients and improves the patient experience compared with patients who have not yet accessed the intervention and are receiving usual care. |
| Ethics approval(s) | Submitted to University College London Hospital A Research Ethics Committee, pending approval on 24th September 2009 |
| Health condition(s) or problem(s) studied | Palliative care for cancer survivors |
| Intervention | Patients who are selected for the intervention group will be offered immediate referral to the day therapy unit and will receive an individual systematic assessment by a senior member of the medical/nursing team. This will be followed by a process of goal setting, agreed with the patient, who is then referred to appropriate members of the multidisciplinary team selected on a case by case basis according to current need. Patients will have access to a range of individual and group therapies including access to medical outpatient clinics with palliative care specialists, counselling, physical rehabilitation, and alternative therapies (art therapy, aromatherpy, hydrotherapy). Those randomised to usual care will join a waiting list and gain access to the intervention after follow-up. Follow-up will be 3 months after baseline, and therefore duration of treatment will be up to 3 months in length, but will depend on how quickly the patient is referred to the service following randomisation (we expect minimum treatment duration of 6 weeks). |
| Intervention type | Other |
| Primary outcome measure | The psychological domain on the long form of Supportive Care Needs Survey (SCNS LF59), assessed at baseline and three months follow-up. |
| Secondary outcome measures | 1. Continuity of care (Continuity of Care measure) 2. Psychological status (KD10) 3. Quality of life (EQ5D) 4. Physical function (measured by the ECOG) 5. Costs associated with the intervention and health service use will also be collected Outcomes will be assessed at baseline and three months follow-up. |
| Overall study start date | 31/10/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 240 patients in total across both sites |
| Key inclusion criteria | 1. Patients who are attending Haematology and Breast Outpatient Departments at the Royal Free Hospital, London or University College London Hospitals 2. Patients with active, progressive recurrent malignant disease (first or subsequent remission) 3. Patients aged 18 years and above, either sex 4. Patients who are able to communicate effectively |
| Key exclusion criteria | 1. Patients who are considered to be cured of their malignant disease 2. Patients who have non-malignant disease only 3. Patients under 18 years old 4. Patients who are unable to feedback and communicate effectively |
| Date of first enrolment | 31/10/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department Mental Health Sciences
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Sponsor information
University College London (UCL) (UK)
University/education
University/education
Joint UCL, UCLH and RFH Biomedical Research Unit
1st Floor, Maple House
149 Tottenham Court Road
London
W1T 7NF
England
United Kingdom
| Website | http://www.ucl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
North London Cancer Network (UK)
No information available
Department of Health (UK) - NHS Improvement Plan
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2013 | Yes | No |
Editorial Notes
27/11/2015: Publication reference added.
