Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7042
Study information
Scientific title
Pilot study to assess provision of simple support services information versus standard care in managing social difficulties in routine oncology practice
Acronym
Study hypothesis
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
Leeds (Central) Research Ethics Committee, 11/05/2009, ref: 09/H1313/4
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
14/09/2009
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 60; UK sample size: 60
Participant exclusion criteria
1. Does not meet inclusion criteria
2. Aged under 18 years
Recruitment start date
14/09/2009
Recruitment end date
31/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychosocial Oncology and Clinical Practice Research Group
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C7775/A7424)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
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