Managing social difficulties in routine oncology practice

ISRCTN	ISRCTN51257605
DOI	https://doi.org/10.1186/ISRCTN51257605
Secondary identifying numbers	7042

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 16/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Emma Ingleson
Scientific

Psychosocial Oncology and Clinical Practice Research Group
Beckett Street
Leeds
LS9 7TF
United Kingdom

Study information

Study design	Single centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Pilot study to assess provision of simple support services information versus standard care in managing social difficulties in routine oncology practice
Study objectives	The primary objective of this study is to assess whether provision of information on support services can enhance patient well-being compared to standard practice. Specific aims are to develop and evaluate a Support Services Information Pack (SSIP) for patients, investigate the impact of this information provision on the process of care and patient well-being, and provide estimates of the effect size of this intervention in a future randomised trial. The main hypothesis is that simple information provision will improve detection of social difficulties, lead to a change in the process of care, lead to an increase in support accessed and an enhancement of patient well-being compared to standard care.
Ethics approval(s)	Leeds (Central) Research Ethics Committee, 11/05/2009, ref: 09/H1313/4
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: Bone, Head and Neck, Myeloma
Intervention	All patients on the study are asked to complete baseline measures (recording of an out-patient review consultation with their doctor and four questionnaires). Patients are then randomised into an intervention (treatment) arm, or a control arm. Those in the intervention arm will be provided with a Support Services Information Pack. Those in the control arm receive standard care (i.e. no additional information or interventions to those already available from their clinical teams or within the hospital). All patients, regardless of arm, are on the study for a further 3 consecutive out patient review appointments (4 in total including baseline). Therefore the length of follow-up varies depending on their treatment, but will be between 4 to 12 weeks, with some exceptions. Patients are also asked to participate in an exit interview which can be completed within 2 weeks of completion of their participation in the study. Follow-up length: 4 months Study entry: registration and one or more randomisations 29/08/2012: Please note that as of 27/07/2012 patient recruitment was stopped due to the objectives becoming inviable and a lack of participants and staff. Interviews with staff will continue until 31/12/2012.
Intervention type	Other
Primary outcome measure	1. Cancer Rehabilitation Evaluation System-Short Form (CARES-SF) 2. Hospital Anxiety and Depression Scale (HADS) 3. Social Difficulties Inventory (SDI-21) Measured at baseline (prior to any intervention) and end of study (after four months).
Secondary outcome measures	1. Patient checklists: recording use of services at baseline and end of study 2. Nurse checklists: recording informal contact between nursing staff running the clinic and participating patients, measured at baseline, visits 1 - 3 and end of study 3. Audio recording: recording consultations that participating patients have with the doctors, measured at baseline, visits 1 - 3 and end of study
Overall study start date	14/09/2009
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 60; UK sample size: 60
Key inclusion criteria	1. Be able to read and understand English 2. Have the capacity to give informed consent and complete the questionnaires 3. Not be participating in any other psychosocial studies 4. Be on active treatment having completed at least one cycle of chemotherapy and commenced radiotherapy 5. Be planning to continue treatment and attend the hospital for four consecutive appointments over 3 to 6 months 6. Male and female, lower age limit of 18 years
Key exclusion criteria	1. Does not meet inclusion criteria 2. Aged under 18 years
Date of first enrolment	14/09/2009
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Psychosocial Oncology and Clinical Practice Research Group

Leeds
LS9 7TF
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom

Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C7775/A7424)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

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

Editorial Notes

16/03/2016: No publications found, verifying study status with principal investigator.