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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Other: Palliative homecare nursing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Frederiksberg
    • Copenhagen, Frederiksberg, Denmark, 2000
      • Frederiksberg Hopsital
  • NV
    • Copenhagen, NV, Denmark, 2400
      • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Quality of life; Palliative care; Advanced cancer; Family nursing; Community nursing; Coping; Needs assessment; Family satisfaction; Hospital readmission
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Danish Cancer Society; The Novo Nordic Foundation; Lundbeck Foundation; Sygekassernes Helsefond; Danish Nurses Organisation; Danish Regions
• Investigators: Study Director: Susan Rydahl Hansen, Cand.cur, PhD, Research Unit of Clinical Nursing, Bispebjerg Hospital; Principal Investigator: Anne Birgitte Hjuler Ammari, Cand.scient.san, Research Unit of Clinical Nursing, Bispebjeg Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (Estimate): September 30, 2011

Study Record Updates

• Last Update Posted (Estimate): July 18, 2014
• Last Update Submitted That Met QC Criteria: July 17, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: FamCope2011