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Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039100
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Iben Husted Nielsen, Rigshospitalet, Denmark

Brief Summary:

Background: Family caregivers are of great importance to patients undergoing treatment for cancer, but at the same time, caregivers themselves are in great risk of distress and high symptom burden which affects their quality of life and ability to support the patients. Within hematology the context of treatment from hospital to home has changed in the past years placing more responsibilities on caregivers. Finding new ways to support caregivers within the health care context is important. Psychosocial interventions can enhance emotional well-being, and peer to peer support model has been found to be effective for patients coping with cancer. There is a lack of knowledge and evidence of the feasibility and effects of a peer-to-peer support in caregivers within hematology.

Aims: The study aim to examine the feasibility and safety of Family Caregiver Ambassador Support in caregivers of newly diagnosed patients with hematological disease, and to examine if it has an effects on symptoms and psychological wellbeing in both family caregivers and ambassadors. It is hypothesized that the family caregiver peer to peer support model will reduce symptoms of burden, reduce concerns and improve emotional and social well-being in family caregivers.

Design and methods: The study is a one arm feasibility intervention trial with family caregivers (n=30) and family caregiver ambassadors (N=20). Family Caregivers will be recruited at the Department of Hematology, Rigshospitalet. Family Caregivers will be partnered with a family caregiver ambassador. The intervention will be carried out in a 12-week period and consist of telephone and/or e-mail contact and face to face meetings with one follow-up at three months. Both caregiver and ambassador data will be collected at baseline, post intervention and follow-up 3 months.

Implication: The study has the potential to be a new model of care incorporated in the clinical setting to strengthen the support system for caregivers and may likely be tailored to other cancer groups and caregivers.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Lymphoma Bone Marrow Transplantation Neoplasms Hematologic Diseases Leukemia, Myeloid Other: Family Caregiver Ambassador Support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease (FAM CARE) - a Feasibility Study
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Family Caregiver Ambassador Support
Intervention group: caregivers of newly diagnosed patients (n=30), former family caregivers as ambassadors (n=20)
Other: Family Caregiver Ambassador Support
Family Caregiver Ambassador Support, with former caregivers of patients treated for hematological malignancies, being ambassadors for caregivers of newly diagnosed patients for a period of 12 weeks




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: Up to 2 years ]
    Number of participants included from eligible family caregivers

  2. Adherence to intervention [ Time Frame: up to 24 weeks ]
    Number of weeks completed out of planned weeks of intervention

  3. Emotional reactions (quality of contacts) [ Time Frame: up to 24 weeks ]
    Registration on descriptive data on content of contacts with project team members (primary investigator/project psychologist/project nurse)

  4. Emotional reactions (numbers of contacts) [ Time Frame: up to 24 weeks ]
    Registration on numbers of contacts with project team members (primary investigator/project psychologist/project nurse)


Secondary Outcome Measures :
  1. Depression [ Time Frame: Change measures (baseline, 12 weeks, 24 weeks) ]
    Measured with the Hospital Anxiety and Depression Scale (HADS)

  2. Anxiety [ Time Frame: Change measures (baseline, 12 weeks, 24 weeks) ]
    Measured with the Hospital Anxiety and Depression Scale (HADS)

  3. Sleep [ Time Frame: Change measures (baseline, 12 weeks, 24 weeks) ]
    Measured with the Pittsburgh Sleep Quality Index (PSQI)

  4. Health-related quality of life [ Time Frame: Change measures (baseline, 12 weeks, 24 weeks) ]
    Measured with the Short form-36 (SF-36)

  5. Self-efficacy [ Time Frame: Change measures (baseline, 12 weeks, 24 weeks) ]
    Measured with the General Self-Efficacy Scale questionnaire. Scale ranges with total scores (higher scores indicating better self-efficacy)

  6. Caregiver roles and responsibilities [ Time Frame: Change measures (baseline, 12 weeks, 24 weeks) ]
    Measured with the Caregiver Roles and Responsibilities Scale (CRRS) questionnaire measuring cancer impact on the lives of caregivers, each subscale provided by total scores

  7. Number of contacts between family caregiver and ambassador [ Time Frame: Up to 12 weeks ]
    Measured by the total number of contacts during the planned weeks of intervention.

  8. Length of contacts between family caregiver and ambassador [ Time Frame: Up to 12 weeks ]
    Measured by the total time of contacts during the planned weeks of

  9. Thematic content of the contacts between family caregiver and ambassador [ Time Frame: Up to 12 weeks ]
    Measured by ambassadors registrations and descriptions of thematic content of the contacts with the family caregiver



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:   Yes
Criteria

Inclusion Criteria:

  • Eligible family caregivers (FC) are ≥ 18 years old and a family member or significant other of a patient with hematological malignancy in one of three categories: 1) acute: newly diagnosed with acute leukemia/high risk myelodysplastic syndrome (MDS) or lymphoma ≤ 4 weeks from diagnosis who will receive intensive chemotherapy (n=10), 2) chronic: diagnosed with myeloma or chronic leukemia/MDS or lymphoma to receive less intensive chemotherapy or palliation (n=10) and 3) complex course of treatment: to undergo a stem cell transplantation (n=10).
  • Eligible Family Caregiver Ambassadors (FCA) are ≥18 years old and a family caregiver of a survivor of a patient with hematological malignancy (in complete remission) and provides consent to participate in the ambassador training program. Informed written consent will be provided by all participants

Exclusion Criteria:

  • Participants (FC and FCA) will be excluded if they do not understand, read and speak Danish, if they have unstable medical disease or cognitive/psychiatric disorders

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): NCT04039100


Contacts
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Contact: Iben H Nielsen, ph.d. stud. 0045 26227757 iben.husted.nielsen@regionh.dk
Contact: Mary Jarden, ph.d. mary.jarden@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Østerbro, Denmark, 2100
Contact: Iben Husted Nielsen    0045 26227757    iben.husted.nielsen@regionh.dk   
Contact: Mary Jarden, ph.d.       mary.jarden@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Director: Mary Jarden, ph.d. Rigshospitalet, Denmark
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Responsible Party: Iben Husted Nielsen, Principal Investigator, Ph.D.student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04039100    
Other Study ID Numbers: FAM CARE
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
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 Iben Husted Nielsen, Rigshospitalet, Denmark:
Peer to Peer
Psychosocial Support
Caregivers
Additional relevant MeSH terms:
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Multiple Myeloma
Leukemia, Myeloid
Hematologic Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Leukemia