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

Department Mental Health Sciences
Royal Free Hospital
Rowland Hill Street
London
NW3 2PF
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled trial to evaluate a complex rehabilitative intervention for patients with advanced progressive recurrent cancer
Study objectivesThe 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) studiedPalliative care for cancer survivors
InterventionPatients 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 typeOther
Primary outcome measureThe psychological domain on the long form of Supportive Care Needs Survey (SCNS LF59), assessed at baseline and three months follow-up.
Secondary outcome measures1. 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 date31/10/2009
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants240 patients in total across both sites
Key inclusion criteria1. 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 criteria1. 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 enrolment31/10/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department Mental Health Sciences
London
NW3 2PF
United Kingdom

Sponsor information

University College London (UCL) (UK)
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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.