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Family and Coping Oriented Palliative Homecare Nursing as a Supplement to Standard Homecare Nursing Aimed at Advanced Cancer Patients - a Randomized Intervention Trial

Phase 3
18 Years
Open (Enrolling)
Advanced Cancer

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Trial Information

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.

Inclusion Criteria:

At least one of the following

- Cancer stage 3 or 4 (according to hospital journal)and at least one treatment after
relapse without satisfying effect on the disease

- The patient is aware that further treatment is of palliative or life prolonging

And also all of following inclusion criterions

- The patient has a family member that would like to participate (The family member
must be involved in the patients care at least two times a week)

- At least 18 years old (patient and family member)

- Understand and speak danish (patient and family member)

- Live in the area of the municipalities of Copenhagen or Frederiksberg

- Discharge from hospital to own home

- Written informed consent (patient and family member)

Exclusion Criteria:

- Terminal fase of disease

- Contact with specialised palliative care

- Incapable of co-operating with trial protocol

- Participant in another behavioral intervention study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Patient reported health related quality of life

Outcome Description:

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.

Outcome Time Frame:

Baseline, week 9, week 16 and week 24

Safety Issue:


Principal Investigator

Susan Rydahl Hansen, Cand.cur, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Research Unit of Clinical Nursing, Bispebjerg Hospital


Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:




Start Date:

October 2011

Completion Date:

April 2014

Related Keywords:

  • Advanced Cancer
  • Neoplasms