Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09/H0714/46
Study information
Scientific title
A randomised controlled trial to evaluate a complex rehabilitative intervention for patients with advanced progressive recurrent cancer
Acronym
Study hypothesis
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
Submitted to University College London Hospital A Research Ethics Committee, pending approval on 24th September 2009
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
31/10/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240 patients in total across both sites
Participant 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
Recruitment start date
31/10/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department Mental Health Sciences
London
NW3 2PF
United Kingdom
Sponsor information
Organisation
University College London (UCL) (UK)
Sponsor details
Joint UCL
UCLH and RFH Biomedical Research Unit
1st Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
North London Cancer Network (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department of Health (UK) - NHS Improvement Plan
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23182307