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Development and evaluation of a psycho-educational intervention for patients with advanced cancer who have cachexia and their lay carers
ISRCTN ISRCTN22427358
DOI 10.1186/ISRCTN22427358
ClinicalTrials.gov identifier
EudraCT number
Public title Development and evaluation of a psycho-educational intervention for patients with advanced cancer who have cachexia and their lay carers
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
Acronym N/A
Serial number at source 1
Study hypothesis 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.
Lay summary Lay summary under review with external organisation
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cancer Palliative Care
Participants - 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 Ďsignificant otherí 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.
Participants - 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
Anticipated start date 01/01/2013
Anticipated end date 31/08/2017
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 200
Interventions 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.
Primary outcome measure(s) 1. The effect of the psycho-educational intervention upon the patientís 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 carerís psychological well being two weeks after gaining access to the intervention, as measured the GHQ8.
Secondary outcome measure(s) 1. The effect of the psycho-educational intervention upon the patientís and carerís 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 patientís Self-reported family and friends are pressuring me to eat VAS.
2. The effect of the psycho-educational intervention upon the patientís and carerís coping mechanism as measured by the COPE questionnaire 11
3. The effect of the psycho-educational intervention upon the carerís 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 carerís three-month post-bereavement.
Sources of funding The All Ireland Institute of Hospice and Palliative Care (Ireland)
Trial website
Publications
Contact name Dr  Joanne  Reid
  Address Queen's University Belfast
School of Nursing & Midwifery
Medical Biology Centre
97 Lisburn Road
  City/town Belfast
  Zip/Postcode BT9 7BL
  Country United Kingdom
  Tel +44 (0)2890 972 459
  Email j.reid@qub.ac.uk
Sponsor Queen's University Belfast (UK)
  Address University Road
  City/town Belfast
  Zip/Postcode BT7 1NN
  Country United Kingdom
  Sponsor website: http://www.qub.ac.uk/
Date applied 16/11/2012
Last edited 10/07/2014
Date ISRCTN assigned 08/01/2013
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