Evaluation of a palliative day care service for cancer survivors
| ISRCTN | ISRCTN22485853 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22485853 |
| Protocol serial number | 09/H0714/46 |
| Sponsor | University College London (UCL) (UK) |
| Funders | North London Cancer Network (UK), Department of Health (UK) - NHS Improvement Plan |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
The psychological domain on the long form of Supportive Care Needs Survey (SCNS LF59), assessed at baseline and three months follow-up. |
| Key secondary outcome measure(s) |
1. Continuity of care (Continuity of Care measure) |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 240 |
| 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
- United Kingdom
- England
Study participating centre
Department Mental Health Sciences
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/11/2015: Publication reference added.
