Clinical trial NCT01444157: Family and Coping Oriented Palliative Homecare Nursing Aimed at Advanced Cancer Patients
Official title: Family and Coping Oriented Palliative Homecare Nursing as a Supplement to Standard Homecare Nursing Aimed at Advanced Cancer Patients - a Randomized Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Cancer
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Lundbeck Foundation
name: Sygekassernes Helsefond
name: The Novo Nordic Foundation
name: Danish Nurses Organisation
name: Danish Regions
First posted: 2011-09-30
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: When facing life threatening illness such as advanced cancer palliative care is needed to improve quality of life of patients and their families through the prevention and relief of suffering. Palliative care at an early stage prevents the development of problems and symptoms, but time, resources and experience are needed in the primary care sector in Denmark to deal with the problems families experiencing life with advanced cancer are facing. The aims of this study are to test, evaluate and further develop interventions that can help identify and assess problems, resources and opportunities of families experiencing life with advanced cancer, and on this background to help the families cope with their situation in cooperation with healthcare professionals to an extent where the family's quality of life increases, their physical and psychosocial problems are relieved, their symptoms of anxiety and depression are reduced, family satisfaction with health professionals are increased and acute readmissions to hospital are prevented.

Detailed description: 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.

Eligibility criteria: 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 nature

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

Primary outcomes:
measure: Patient reported health related quality of life
timeFrame: Baseline, week 9, week 16 and week 24
Secondary outcomes:
measure: Patient reported symptoms and problems
timeFrame: Baseline, week 9, week 16 and week 24
measure: Patients symptoms of anxiety and depression
timeFrame: Baseline, week 9, week 16 and week 24
measure: Family members symptoms of anxiety and depression
timeFrame: Baseline, week 9, week 16, week 24 and 12 months
measure: Family members health related quality of life
timeFrame: Baseline, week 9, week 16, week 24 and 12 months
measure: Family satisfaction with the health care services provided to the patient
timeFrame: Baseline, week 9, week 16, week 24 and 12 months
measure: Acute readmission to hospital
timeFrame: week 16 and 24
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Frederiksberg Hopsital
state: Frederiksberg
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: NV
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Research Unit of Clinical Nursing, Bispebjerg Hospital
name: Susan Rydahl Hansen, Cand.cur, PhD
role: STUDY_DIRECTOR
affiliation: Research Unit of Clinical Nursing, Bispebjeg Hospital
name: Anne Birgitte Hjuler Ammari, Cand.scient.san
role: PRINCIPAL_INVESTIGATOR
References: