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
Protocol serial number 1
Sponsor Queen's University Belfast (UK)
Funder The All Ireland Institute of Hospice and Palliative Care (Ireland)
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

http://www.cancerresearchuk.org/about-cancer/trials/a-study-help-people-advanced-cancer-who-losing-weight

Contact information

Dr Joanne Reid
Scientific

Queen's University Belfast
School of Nursing & Midwifery
Medical Biology Centre
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

+44 (0)2890 972 459
j.reid@qub.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleDevelopment and evaluation of a psycho-educational intervention for patients with advanced cancer who have cachexia and their lay carers: a randomised controlled trial
Study objectivesPatients 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) studiedCancer Palliative Care
InterventionThe 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 typeOther
Primary outcome measure(s)

1. The effect of the psycho-educational intervention upon the patient’s 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 carer’s psychological well being two weeks after gaining access to the intervention, as measured the GHQ8.

Key secondary outcome measure(s)

1. The effect of the psycho-educational intervention upon the patient’s and carer’s 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 patient’s Self-reported family and friends are pressuring me to eat VAS.
2. The effect of the psycho-educational intervention upon the patient’s and carer’s coping mechanism as measured by the COPE questionnaire 11
3. The effect of the psycho-educational intervention upon the carer’s 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 carer’s three-month post-bereavement.

Completion date31/08/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration200
Key inclusion criteriaParticipants 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 criteria1. 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 enrolment01/01/2013
Date of final enrolment31/08/2017

Locations

Countries of recruitment

  • United Kingdom
  • Northern Ireland

Study participating centre

Queen's University Belfast
Belfast
BT9 7BL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
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
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