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Trial registered on ANZCTR


Registration number
ACTRN12609000636257
Ethics application status
Not yet submitted
Date submitted
1/05/2009
Date registered
29/07/2009
Date last updated
29/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The Meaning of Meals to Patients and Family Carers at the End of Life:
Development and Testing of a Psychosocial Intervention for Eating Related Distress
Scientific title
Development and efficacy of "Eating Related Distress (ERD)" booklet for hospice patients' and family carers' ERD and dyadic discord
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating related distress at the end of life 4708 0
Condition category
Condition code
Diet and Nutrition 5024 5024 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6-8 page interactive booklet with information about eating related distress and mechanisms for readers (patients or family carers) to become more self aware about how they contribute to this psychosocial distress, and suggestions for how to address this distress. The way the participants read the booklet will not be monitored; however, post-intervention questions include one assessing for how long the participant read the intervention booklet. The experimental group participants will be given the intervention booklet at Time 1, and then after they have had it 1-3 weeks, they will be given the Time 2 questionnaires.
Intervention code [1] 4472 0
Other interventions
Comparator / control treatment
Standard care for eating related distress is the nurse listening to the emotional pain manifest in eating related distress, then based on the nurse's empathic listening skills, using communication techniques such as open questions, restatements, or reflecting emotions. The nurse may make suggestions about how to minimize the distress, but these are likely to target dietary or nutritional aspects, not emotional aspects of eating. It is also possible the nurse may refer the patient or family carer to written resources about support terminally ill patients nutritionally. Thus, standard care is "soft" and varies with skill of the nurse, and includes information about nutrition, not emotional distress related to poor nutrition.
Control group
Active

Outcomes
Primary outcome [1] 5865 0
decreased eating related distress (as measured by Memorial Symptom Assessment scale eating related items-distress response (significant decrease in mean from pre- to post-intervention)
Timepoint [1] 5865 0
measured at one timepoint from 1-3 weeks after completing intervention
Secondary outcome [1] 241896 0
decrease in mean dyadic discord as measured by Couple Satisfaction Index-4
Timepoint [1] 241896 0
measured at one timepoint from1-3 weeks after completing intervention

Eligibility
Key inclusion criteria
hospice patient or primary family carer of; 18 years or older; able to understand spoken English
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
absence of nurse-observed mental or psychiatric impairment (other than situational depression)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A listing of all patients receiving hospice care from Mary Potter Hospice (MPH) at the time when the study is ready to commense Phase 2 data collection will be printed out in the order of when they entered the hospice's service (those being on service the longest being at the top of the listing). Then the patient (along with their respective family carer) will be allocated to the experimental or control group based on the randomization plan generated by Randomization.com using randonly permuted blocks. If additional participants are needed (ie, if at the time of Phase 2 data collection starting, the listing of patients does not produce the required 176 participants), patients subsequently entering MPH service will be randomized using the same method. That is, each successive patient entering MPH service will be allocated using the same randomization plan.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1745 0
New Zealand
State/province [1] 1745 0

Funding & Sponsors
Funding source category [1] 4886 0
Charities/Societies/Foundations
Name [1] 4886 0
Mary Potter Hospice
Address [1] 4886 0
48 Mein St.
Wellington South, 6242
Country [1] 4886 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Mary Potter Hospice
Address
Po Box 7442, 48 Mein St.
Wellington South, 6242
Country
New Zealand
Secondary sponsor category [1] 4418 0
None
Name [1] 4418 0
Address [1] 4418 0
Country [1] 4418 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6951 0
Central Region, Health & Disability Ethics Committee
Ethics committee address [1] 6951 0
Ethics committee country [1] 6951 0
New Zealand
Date submitted for ethics approval [1] 6951 0
08/05/2009
Approval date [1] 6951 0
Ethics approval number [1] 6951 0

Summary
Brief summary
This study will generate evidence for an intervention (Phase 1) which addresses the psychosocial distress related to not eating amongst those at the end of life, and test the efficacy of this intervention (Phase 2), as well as examine relationships between ERD and other factors. It is hypothesized that the intervention will significantly reduce eating related distress and dyadic distress.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29559 0
Address 29559 0
Country 29559 0
Phone 29559 0
Fax 29559 0
Email 29559 0
Contact person for public queries
Name 12806 0
Elizabeth Johnston Taylor
Address 12806 0
PO Box 7442, 48 Mein St.
Wellington South, 6242
Country 12806 0
New Zealand
Phone 12806 0
+64 04 389 5017 extension711
Fax 12806 0
Email 12806 0
beth.taylor@marypotter.org.nz
Contact person for scientific queries
Name 3734 0
Elizabeth Johnston Taylor
Address 3734 0
48 Mein St.
Wellington South, 6242
Country 3734 0
New Zealand
Phone 3734 0
+64 04 389 5017
Fax 3734 0
Email 3734 0
beth.taylor@marypotter.org.nz

No information has been provided regarding IPD availability
Summary results
No Results