Condition category
Cancer
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
16/03/2016
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

Ms Emma Ingleson

ORCID ID

Contact details

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

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 measures

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

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

http://www.leeds.ac.uk/

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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