Development and evaluation of a psycho-educational intervention for patients with advanced cancer who have cachexia and their lay carers
| ISRCTN | ISRCTN22427358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22427358 |
| Secondary identifying numbers | 1 |
- Submission date
- 16/11/2012
- Registration date
- 08/01/2013
- Last edited
- 26/09/2014
- 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
Contact information
Dr Joanne Reid
Scientific
Scientific
Queen's University Belfast
School of Nursing & Midwifery
Medical Biology Centre
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom
| Phone | +44 (0)2890 972 459 |
|---|---|
| j.reid@qub.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Development and evaluation of a psycho-educational intervention for patients with advanced cancer who have cachexia and their lay carers: a randomised controlled trial |
| Study objectives | Patients and lay carers receiving a psycho-educational intervention in addition to standard care will have a clinically significant improvement in psychological well-being compared to those receiving standard care alone. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer Palliative Care |
| Intervention | The intervention will comprise a DVD and a follow-up phone call. The content of the DVD has been informed by previous qualitative studies with this patient group which identified the problems and concerns experienced by patients and their lay carers. The information contained within the DVD will specifically focus on: 1. Managing distress 2. Conflict and arguments over food 3. The psychological impact of appetite and weight loss, including body image 4. Diet and exercise 5. Fatigue management 6. Managing social situations 7. A mindfulness exercise Scripts highlighting the content of the DVD. |
| Intervention type | Other |
| Primary outcome measure | 1. The effect of the psycho-educational intervention upon the patients psychological well being two weeks after gaining access to the intervention, as measured by the General Health Questionnaire-12 (GHQ)8. 2. The effect of the psycho-educational intervention upon the carers psychological well being two weeks after gaining access to the intervention, as measured the GHQ8. |
| Secondary outcome measures | 1. The effect of the psycho-educational intervention upon the patients and carers level of distress from lack of appetite and weight loss two weeks after gaining access to the intervention, as measured by the Self-reported Eating Related Distress and Weight Related Distress Visual Analogue Scales (VASs) 9 and the patients Self-reported family and friends are pressuring me to eat VAS. 2. The effect of the psycho-educational intervention upon the patients and carers coping mechanism as measured by the COPE questionnaire 11 3. The effect of the psycho-educational intervention upon the carers perception of their readiness for their role two weeks following the intervention, as measured by the Preparedness for Care Giving Scale 12. 4. To explore the usefulness of the intervention for patients who have advanced cancer and cachexia and their lay carers, through conducting qualitative semi-structured interviews with carers three-month post-bereavement. |
| Overall study start date | 01/01/2013 |
| Completion date | 31/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | Participants will be patient carer dyads where the patient has a diagnosis of advanced cancer with cachexia. 1. Aged 18 and over 2. Can read and write English 3. Have a confirmed diagnosis of advanced and incurable cancer 4. Have weight loss which does not have the potential to be reversed 5. Have access to a DVD player Patients will be asked to nominate a significant other who has observed the difficulties they are experiencing as a result of living with cancer cachexia. Inclusion criteria for the lay carers will include: 1. Aged 18 or over 2. Have regular face to face contact with the patient (at least five times per week) 3. Have access to a DVD player All participants will be required to provide their written informed consent. |
| Key exclusion criteria | 1. They are not living in their own home 2. They are experiencing symptoms too severe to allow participation 3. They have not had an end of life conversation with a member of the palliative care/day services team 4. They do not have access to a DVD player |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/08/2017 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Queen's University Belfast
Belfast
BT9 7BL
United Kingdom
BT9 7BL
United Kingdom
Sponsor information
Queen's University Belfast (UK)
University/education
University/education
University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom
| Website | http://www.qub.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00hswnk62 |
Funders
Funder type
Hospital/treatment centre
The All Ireland Institute of Hospice and Palliative Care (Ireland)
No information available
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 |
