Condition category
Cancer
Date applied
16/11/2012
Date assigned
08/01/2013
Last edited
26/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Joanne Reid

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

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

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/01/2013

Overall trial end date

31/08/2017

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/01/2013

Recruitment end date

31/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's University Belfast
Belfast
BT9 7BL
United Kingdom

Sponsor information

Organisation

Queen's University Belfast (UK)

Sponsor details

University Road
Belfast
BT7 1NN
United Kingdom

Sponsor type

University/education

Website

http://www.qub.ac.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

The All Ireland Institute of Hospice and Palliative Care (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes