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

NCT01444157 | Completed Phase 3 DMC

• 1 other identifier: FamCope2011
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patient reported symptoms and problems

  Baseline, week 9, week 16 and week 24

• Patients symptoms of anxiety and depression

  Baseline, week 9, week 16 and week 24

• Family members symptoms of anxiety and depression

  Baseline, week 9, week 16, week 24 and 12 months

• Family members health related quality of life

  Baseline, week 9, week 16, week 24 and 12 months

• Family satisfaction with the health care services provided to the patient

  Baseline, week 9, week 16, week 24 and 12 months

Study Arms (2)

Palliative homecare nursing group

EXPERIMENTAL

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

Standard homecare nursing group

NO INTERVENTION

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.

Interventions

Palliative homecare nursing 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.

Also known as: Palliative care, Advanced cancer, Family nursing, Community nursing, Coping, Quality of life, Needs assessment, Family satisfaction, Hospital readmission

Palliative homecare nursing group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• Terminal fase of disease
• Contact with specialised palliative care
• Incapable of co-operating with trial protocol
• Participant in another behavioral intervention study

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Danish Cancer Society: collaborator
• Lundbeck Foundation: collaborator
• Sygekassernes Helsefond: collaborator
• The Novo Nordic Foundation: collaborator
• Danish Nurses Organisation: collaborator
• Danish Regions: collaborator

Study Sites (3)

Frederiksberg Hopsital

Copenhagen, Frederiksberg, 2000, Denmark

Location

Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Palliative Care; Coping Skills; Quality of Life; Needs Assessment; Patient Readmission

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Hospitalization

Study Officials

• Susan Rydahl Hansen, Cand.cur, PhD

  Research Unit of Clinical Nursing, Bispebjerg Hospital

  STUDY DIRECTOR

• Anne Birgitte Hjuler Ammari, Cand.scient.san

  Research Unit of Clinical Nursing, Bispebjeg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: September 30, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

DK (3)