Family and Coping Oriented Palliative Homecare Nursing as a Supplement to Standard Homecare Nursing Aimed at Advanced Cancer Patients - a Randomized Intervention Trial
Screening for patients will take place in the oncological, gynecological medical, surgical
departments of three hospitals in Copenhagen, Denmark among patients diagnosed with cancer.
Patients eligible for the study will be informed about the study during hospital admission
and asked to participate together with a close relative/family member. When written informed
consent has been obtained from both patient and relative they will be asked to fill in
questionnaires with background information about sociodemographic data, their physical and
psychosocial functioning and quality of life EORTC (QLQ-C30/patient and SF36/relative),
their symptoms of anxiety and depression (HAD Scale/patient and relative) and family
satisfaction with health care professionals(FamCare/relative). When patients have been
discharge from hospital to their own home the families are randomized to control or
intervention group. First visit from the research nurse takes place no later than one week
after randomization. Visits takes place week 1,4,7,10,13 and 16 after randomization. The
questionnaires EORTC QLQ-C30 (patient), HAD Scale (patient and relative), SF 36 (relative)
and FamCare (relative) are mailed by post to the families to be answered at week 9, 16 and
24 after randomization. Information about the amount of care the family receives from the
municipality (standard homecare) will be obtained from municipal registers. Information
about readmissions to hospital are obtained from hospital registers.
The research nurses has a minimum of one year experience within specialised palliative care.
The nurses has also participated in a two day course on how to produce and utilise family
assessment and have been introduced to the background theory on coping and family nursing.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Patient reported health related quality of life
The change in mean scores from baseline to each follow up as measured in the Quality of life questionnaire EORTC QLQ-C30 scale score(Developed by the European Organization for Research and Treatment of Cancer)in relation to the Global health status scale.
Baseline, week 9, week 16 and week 24
No
Susan Rydahl Hansen, Cand.cur, PhD
Study Director
Research Unit of Clinical Nursing, Bispebjerg Hospital
Denmark: The Regional Committee on Biomedical Research Ethics
FamCope2011
NCT01444157
October 2011
April 2014
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