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Advanced CancerPhase 3FamCopeNCT01444157

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

A Phase 3 study testing Palliative homecare nursing in people with Advanced Cancer, run by Bispebjerg Hospital at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
Palliative homecare nursing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
3 sitesDenmark
Study dates
Oct 2011to Apr 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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)

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Frederiksberg Hopsital

    Copenhagen, Frederiksberg, 2000

  • Bispebjerg Hospital

    Copenhagen, NV, 2400

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

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

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.

Read the 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
Being tested
Palliative homecare nursing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palliative homecare nursingOther

    Also called Palliative care, Advanced cancer, Family nursing, Community 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.

Study groups in NCT01444157
Study groupRoleWhat they receive
Palliative homecare nursing groupExperimentalIn 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.
Receives: Other: Palliative homecare nursing
Standard homecare nursing groupNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, week 9, week 16 and week 24

Secondary outcomes (6)

  1. 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.

    Measured: Baseline, week 9, week 16 and week 24

  2. 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.

    Measured: Baseline, week 9, week 16 and week 24

  3. 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.

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

  4. 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.

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

  5. 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

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

  6. 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

    Measured: week 16 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionOct 2013
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01444157
Sponsor's protocol ID
FamCope2011
Acronym
FamCope
Status last verified
Jul 2014
First submitted
29 Sep 2011
Last updated
18 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palliative homecare nursing in people with Advanced Cancer, run by Bispebjerg Hospital at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient reported health related quality of life (time frame: Baseline, week 9, week 16 and week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01444157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.

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