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

Advanced Cancer Clinical Trial

— FamCope  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444157
• Other study ID #: FamCope2011
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2011
• Last updated: July 17, 2014
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	NV
Denmark	Frederiksberg Hopsital	Copenhagen	Frederiksberg
Denmark	Rigshospitalet	Copenhagen

Sponsors (7)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Danish Cancer Society, Danish Nurses Organisation, Danish Regions, Lundbeck Foundation, Sygekassernes Helsefond, The Novo Nordic Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Patient reported symptoms and problems	The change in mean scores from baseline to each follow up as measured in the EORTC QLQ-C30 questionnaire scale score in relation to its functional scales and symptom scales/items.	Baseline, week 9, week 16 and week 24	No
Secondary	Patients symptoms of anxiety and depression	The change in mean scores from baseline to each follow up according to the HADS questionnaire (Hospital Anxiety and Depression Scale) Scores are self-reported.	Baseline, week 9, week 16 and week 24	No
Secondary	Family members symptoms of anxiety and depression	The change in mean scores from baseline to each follow up according to the HADS questionnaire. Scores are self-reported.	Baseline, week 9, week 16, week 24 and 12 months	No
Secondary	Family members health related quality of life	The change in mean scores from baseline to each follow up. Scores are self-reported and measured in the SF36 v1 questionnaire.	Baseline, week 9, week 16, week 24 and 12 months	No
Secondary	Family satisfaction with the health care services provided to the patient	The change in mean scores from baseline to each follow up. Scores are self-reported and measured in the FAMCARE questionnaire	Baseline, week 9, week 16, week 24 and 12 months	No
Secondary	Acute readmission to hospital	The change in mean number of acute readmissions and mean period of hospitalizations (measured in days) from inclusion to the study to week 16 and 24. Readmissions must be related to the patients cancer disease	week 16 and 24	No