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Development and evaluation of a psycho-educational intervention for patients with advanced cancer who have cachexia and their lay carers

Development and evaluation of a psycho-educational intervention for patients with advanced cancer who have cachexia and their lay carers: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22427358
Enrollment
200
Registered
2013-01-08
Start date
2013-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Palliative Care Cancer

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 conc

Sponsors

Queen's University Belfast (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026