Condition category
Cancer
Date applied
21/09/2009
Date assigned
09/11/2009
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Louise Jones

ORCID ID

Contact details

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

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 measures

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

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

http://www.ucl.ac.uk/

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

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23182307

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.