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Improvement of Support to Caregivers of Cancer Patients in Basic Palliative Care at Home (PiH)

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ClinicalTrials.gov Identifier: NCT03548012
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborators:
Danish Cancer Society
The Municipality of Gentofte
The Municipality of Gladsaxe
The Municipality of Haderslev
The Municipality of Holbæk
The Municipality of Odense
The Municipality of Aalborg
The Municipality of Esbjerg
The Municipality of Hjørring
The Municipality of Næstved
The Municipality of Silkeborg
Information provided by (Responsible Party):
Mogens Groenvold, Bispebjerg Hospital

Brief Summary:
The aim of the project is to evaluate the use of the caregiver-led 'CSNAT intervention' to identify, prioritize and address support needs among caregivers of cancer patients who are starting in basic palliative care at home in Denmark

Condition or disease Intervention/treatment Phase
Palliative Care Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A stepped wedge cluster randomized controlled trial. All clusters (i.e., municipalities) will start as controls and will change to intervention at various times determined by randomization. In this way, all municipalities will contribute to control and intervention groups, thus accounting for variation between municipalities.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Testing a Caregiver-led Intervention to Improve Support to Caregivers of Cancer Patients in Palliative Care at Home: a Stepped Wedge (Cluster) Randomized Controlled Trial
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The Carer Support Needs Assessment Tool (CSNAT) intervention
('Standard' basic palliative care +) The Carer Support Needs Assessment Tool (CSNAT) intervention.
Behavioral: The Carer Support Needs Assessment Tool (CSNAT) intervention
The CSNAT intervention is a caregiver-led approach where the caregiver first identifies his/her needs of support in the CSNAT, which consists of 14 support domains. Then the practitioner facilitates the intervention where the caregiver prioritizes which domains to discuss. In the conversation, the caregiver's domain priorities and subsequently identified support needs are discussed with the practitioner to agree on actions/solutions and a shared action plan. The intervention will be offered each caregiver twice: the first time between 0 and 13 days after enrollment, and the second time between 15 and 27 days after enrollment.

No Intervention: Control
('Standard' basic palliative care). No intervention offered.



Primary Outcome Measures :
  1. Caregiver strain [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Caregiver strain is measured by the subscale 'Caregiver Strain' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a worse outcome, i.e. more caregiver strain.


Secondary Outcome Measures :
  1. Caregiver strain [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Caregiver strain is measured by the subscale 'Caregiver Strain' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a worse outcome, i.e. more caregiver strain.

  2. Positive caregiving appraisals [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Positive caregiving appraisals is measured by the subscale 'Positive caregiving appraisals' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a better outcome, i.e. more positive caregiving appraisals.

  3. Positive caregiving appraisals [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Positive caregiving appraisals is measured by the subscale 'Positive caregiving appraisals' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a better outcome, i.e. more positive caregiving appraisals.

  4. Caregiver distress [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Caregiver distress is measured by the subscale 'Caregiver distress' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a worse outcome, i.e. more caregiver distress

  5. Caregiver distress [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Caregiver distress is measured by the subscale 'Caregiver distress' in the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). Subscale score range: 1-5. A higher score represents a worse outcome, i.e. more caregiver distress

  6. Satisfaction with attention from health care professionals [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals

  7. Satisfaction with attention from health care professionals [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals

  8. Satisfaction with communication with health care professionals [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals

  9. Satisfaction with communication with health care professionals [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals

  10. Satisfaction with information from health care professionals [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Measured with selected items from the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals

  11. Satisfaction with information from health care professionals [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Measured with selected items from the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals

  12. Caregiving workload [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Measured with selected items from the subscale 'Caregiving workload' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more caregiving workload

  13. Caregiving workload [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Measured with selected items from the subscale 'Caregiving workload' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more caregiving workload

  14. Caregiver involvement [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Measured with item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement

  15. Caregiver involvement [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Measured with item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement

  16. Help from health care professionals [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Measured with two newly developed items which ask whether the health care professionals have talked with the caregiver about what burdens them, and whether the health care professionals have helped with these burdens. Item score range: 0-100. A higher score represents a worse outcome, i.e. less help from health care professionals

  17. Help from health care professionals [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Measured with two newly developed items which ask whether the health care professionals have talked with the caregiver about what burdens them, and whether the health care professionals have helped with these burdens. Item score range: 0-100. A higher score represents a worse outcome, i.e. less help from health care professionals

  18. Quality of life [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Measured by the two items assessing overall health and quality of life in the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Item score range: 0-100. A higher score represents a better outcome, i.e. better quality of life

  19. Quality of life [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Measured by the two items assessing overall health and quality of life in the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Item score range: 0-100. A higher score represents a better outcome, i.e. better quality of life

  20. Emotional functioning [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Measured by the four emotional functioning items in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) supplemented with three selected items from the EORTC Computerized Adaptive Test (CAT) emotional functioning item bank. Item/subscale score range: 0-100. A higher score represents a better outcome, i.e. better emotional functioning

  21. Emotional functioning [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Measured by the four emotional functioning items in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) supplemented with three selected items from the EORTC Computerized Adaptive Test (CAT) emotional functioning item bank. Item/subscale score range: 0-100. A higher score represents a better outcome, i.e. better emotional functioning

  22. Fatigue [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Measured by the three fatigue items in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) supplemented with three selected items from the EORTC Computerized Adaptive Test (CAT) fatigue item bank. Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more fatigue

  23. Fatigue [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Measured by the three fatigue items in EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) supplemented with three selected items from the EORTC Computerized Adaptive Test (CAT) fatigue item bank. Item/subscale score range: 0-100. A higher score represents a worse outcome, i.e. more fatigue

  24. Positive emotional functioning [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Measured by five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Item score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning

  25. Positive emotional functioning [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Measured by five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Item score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning

  26. Caregiver grief [ Time Frame: Measured six months after the patient's death ]
    Measured by the Prolonged Grief Scale-13 (PG-13). Symptom subscale score range: 9-45. A higher score represents a worse outcome, i.e. higher level of prolonged grief symptoms

  27. Acute hospitalizations [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Number of acute patient hospitalizations

  28. Acute hospitalizations [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Number of acute patient hospitalizations

  29. Hospice referrals (for in-patient care) [ Time Frame: Change from baseline (enrollment) to day 14 ]
    Number of patients referred to hospice in-patient care

  30. Hospice referrals (for in-patient care) [ Time Frame: Change from baseline (enrollment) to day 28 ]
    Number of patients referred to hospice in-patient care

  31. Survival time [ Time Frame: From enrollment to up to six months after the project recruitment period has closed ]
    Number of days the patient lives

  32. Place of death [ Time Frame: From enrollment to up to six months after the project recruitment period has closed ]
    The place in which the patient dies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient should have advanced cancer
  • The caregiver and patient should be able to read and understand Danish
  • The caregiver and patient should give written informed consent
  • The patient should be newly referred to basic palliative care (BPC) by home nurses in the municipality.

Exclusion Criteria:

  • The caregiver is viewed by the practitioners as being too distressed to be asked about participation
  • The caregiver has a known cognitive impairment precluding participation (based on the practitioners' clinical judgement)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548012


Contacts
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Contact: Mogens Grønvold, DMSc PhD MD +45 38635509 mold@sund.ku.dk
Contact: Lone R Nylandsted, PhD MD +45 3863 5869 lone.ross.nylandsted@regionh.dk

Locations
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Denmark
Aalborg Home Nursing Recruiting
Aalborg, Denmark, 9230
Contact: Bodil F Nielsen, RN    +45 9931 3980    bfn-aeh@aalborg.dk   
Esbjerg Home Nursing Recruiting
Esbjerg, Denmark, 6700
Contact: Anni K Sørensen, RN    +45 2055 4814    ans23@esbjergkommune.dk   
Gentofte Home Nursing Recruiting
Gentofte, Denmark, 2920
Contact: Lars B Hansen       laha@gentofte.dk   
Gladsaxe Home Nursing Recruiting
Gladsaxe, Denmark, 2800
Contact: Susanne Dyremose, RN    +45 5129 0242    SUSDYR@gladsaxe.dk   
Haderslev Home Nursing Recruiting
Haderslev, Denmark, 6200
Contact: Carin Demmer, RN    +45 7434 2841    cade@haderslev.dk   
Hjørring Home Nursing Recruiting
Hjørring, Denmark, 9800
Contact: Hanne Sørensen, RN    +45 5128 1976    hanne.soerensen@hjoerring.dk   
Holbæk Home Nursing Recruiting
Holbæk, Denmark, 4300
Contact: Mikael Skytte, RN    +45 7236 2038    msky@holb.dk   
Næstved Home Nursing Recruiting
Næstved, Denmark, 4700
Contact: Gitte Køtter, RN    +45 5588 1800    gikot@naestved.dk   
Odense Home Nursing Recruiting
Odense, Denmark, 5220
Contact: Line V Sjodsholm, RN       lvsjo@odense.dk   
Silkeborg Home Nursing Recruiting
Silkeborg, Denmark, 8600
Contact: Lene D Frost, RN    +45 2222 6805    Lene.frost@silkeborg.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Danish Cancer Society
The Municipality of Gentofte
The Municipality of Gladsaxe
The Municipality of Haderslev
The Municipality of Holbæk
The Municipality of Odense
The Municipality of Aalborg
The Municipality of Esbjerg
The Municipality of Hjørring
The Municipality of Næstved
The Municipality of Silkeborg
Investigators
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Principal Investigator: Mogens Grønvold, DMSc PhD MD Bispebjerg Hospital

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Responsible Party: Mogens Groenvold, Professor, DMSc, PhD, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03548012     History of Changes
Other Study ID Numbers: R173-A11289-17-S51
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mogens Groenvold, Bispebjerg Hospital:
Caregivers
Support Needs
Intervention
Randomised controlled trial