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

NCT ID: NCT01444157

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-04-30

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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Palliative homecare nursing group

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.

Group Type: EXPERIMENTAL

Palliative homecare nursing

Intervention Type: OTHER

The nurse helps the family assess the identified problems. Written coping strategies according to each problem is produced including actions of the patient, family member, nurse or others. At the same time the nurse keeps attention to the family members specific needs of knowledge and support when handling direct or indirect care, understanding and coping with the disease, treatment, physical, psychosocial and economical problems and the family members own physical and mental health. The nurse provides knowledge to the family on how to prevent and/or cope with problems that may occur or re-occur and/or accepts or adapt to unsolvable problems.

Standard homecare nursing group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Palliative homecare nursing

The nurse helps the family assess the identified problems. Written coping strategies according to each problem is produced including actions of the patient, family member, nurse or others. At the same time the nurse keeps attention to the family members specific needs of knowledge and support when handling direct or indirect care, understanding and coping with the disease, treatment, physical, psychosocial and economical problems and the family members own physical and mental health. The nurse provides knowledge to the family on how to prevent and/or cope with problems that may occur or re-occur and/or accepts or adapt to unsolvable problems.

Intervention Type: OTHER

Other Intervention Names

Palliative care; Advanced cancer; Family nursing; Community nursing; Coping; Quality of life; Needs assessment; Family satisfaction; Hospital readmission

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Cancer Society

OTHER

Sponsor Role: collaborator

Lundbeck Foundation

OTHER

Sponsor Role: collaborator

Sygekassernes Helsefond

OTHER

Sponsor Role: collaborator

The Novo Nordic Foundation

OTHER

Sponsor Role: collaborator

Danish Nurses Organisation

OTHER

Sponsor Role: collaborator

Danish Regions

UNKNOWN

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Birgitte Hjuler Ammari

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Rydahl Hansen, Cand.cur, PhD

Role: STUDY_DIRECTOR

Research Unit of Clinical Nursing, Bispebjerg Hospital

Anne Birgitte Hjuler Ammari, Cand.scient.san

Role: PRINCIPAL_INVESTIGATOR

Research Unit of Clinical Nursing, Bispebjeg Hospital

Locations

Frederiksberg Hopsital

Copenhagen, Frederiksberg, Denmark

Bispebjerg Hospital

Copenhagen, NV, Denmark

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

FamCope2011

Identifier Type: -

Identifier Source: org_study_id