Family and Coping Oriented Palliative Homecare Nursing Aimed at Advanced Cancer Patients (FamCope)

Bispebjerg Hospital

Status and phase: Completed; Phase 3

Conditions: Advanced Cancer

Treatments: Other: Palliative homecare nursing

Study type: Interventional

Funder types: Other

Identifiers

NCT01444157

FamCope2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Palliative homecare nursing group

Experimental group

Description:

In addition to the standard homecare nursing the families will receive six home visits from a research nurse with at least 1 year specialised palliative care experience. During the first 2 hour visit a family assessment is obtained containing identification of family roles, resources and coping strategies. The first home visit takes place no later than one week after randomization. The visits continues every third week up to 16 weeks, each visit with a duration of 1,5 hours. At every visit the EORTC-QLQ-C30 patient administered questionnaire is used to identify the nature, frequency and intensity of the patients physical and psychosocial problems.

Treatment:

Other: Palliative homecare nursing

Standard homecare nursing group

No Intervention group

Description:

Patients continue to receive the standard homecare nursing. They can contact municipality services for visitation to homecare nursing if they feel that additional homecare is needed or if they do not yet receive this service and feel they need homecare nursing.