Condition category
Cancer
Date applied
23/02/2011
Date assigned
23/02/2011
Last edited
25/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Emma Ingleson

ORCID ID

Contact details

Psychosocial Oncology and Clinical Practice Research Group
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0) 113 3433459
e.j.ingleson@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9698

Study information

Scientific title

Pilot study to compare routine assessment versus standard care in managing social difficulties in routine oncology practice

Acronym

Study hypothesis

The primary objective of this study is to explore the feasibility and effectiveness of implementing a programme of assessment for social difficulties, administered by trained nurses. Specific aims are to develop and evaluate a Nurse Training Package (NTP) to enable staff to carry out the assessment. This randomised pilot study will also investigate the impact of this assessment 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 a formal assessment of social difficulties will improve detection of issues, 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 approval date 21/01/2011, ref:11/H1313/3

Study design

Randomised interventional treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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: All

Intervention

Social Difficulties Inventory (SDI-21) Assessment: A formal assessment of the presence and severity of social difficulties, using the SDI-21 administered by a trained nurse. Follow up length: 3 months, study entry : registration and one or more randomisations

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

CARES-SF: Cancer Rehabilitation Evaluation System – Short Form; Timepoints: Baseline and end of study

Secondary outcome measures

HADS: Hospital Anxiety and Depression Scale; Timepoints: Baseline and end of study

Overall trial start date

04/04/2011

Overall trial end date

30/09/2011

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 and touch-screen assessment
3. Not have participated in the initial pilot study, assessing the role of information provision versus standard care
4. Not be participating in any other psychosocial studies
5. Be on active treatment having completed at least 1 cycle of chemotherapy and commenced radiotherapy
6. Bbe planning to continue treatment and attend the hospital for a minimum of two consecutive on-treatment review appointments and a minimum of one post-treatment follow-up appointment
7. Gender: Male and female
8. Lower Age Limit 18, no age limit specified

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

Patients who:
1. Cannot read and understand English
2. Are not on active treatment
3. Are already participating in an existing project being conducted by the Psychosocial Oncology and Clinical Practice Research Group
4. Participated in an initial pilot study, assessing the role of information provision versus standard care

Recruitment start date

04/04/2011

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

School of Medicine
The Worsley Medical & Dental Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

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

25/02/2016: Link added to Cancer Help UK trial summary.