Routine assessment versus standard care in managing social difficulties in routine oncology practice
| ISRCTN | ISRCTN70106175 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70106175 |
| Protocol serial number | 9698 |
| Sponsor | University of Leeds (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- Submission date
- 23/02/2011
- Registration date
- 23/02/2011
- Last edited
- 16/03/2018
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Mrs Emma Ingleson
Scientific
Scientific
Psychosocial Oncology and Clinical Practice Research Group, Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0) 113 3433459 |
|---|---|
| e.j.ingleson@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Pilot study to compare routine assessment versus standard care in managing social difficulties in routine oncology practice |
| Study objectives | 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(s) | Leeds Central Research Ethics Committee, 21/01/2011, ref: 11/H1313/3 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
CARES-SF: Cancer Rehabilitation Evaluation System Short Form; Timepoints: Baseline and end of study |
| Key secondary outcome measure(s) |
HADS: Hospital Anxiety and Depression Scale; Timepoints: Baseline and end of study |
| Completion date | 30/09/2011 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/04/2011 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Psychosocial Oncology and Clinical Practice Research Group, Beckett Street
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/03/2018: The trial was stopped due to participant recruitment issues.
25/02/2016: Link added to Cancer Help UK trial summary.
