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

NCT04039100 | Completed DMC

• 1 other identifier: FAM CARE
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Lymphoma; Bone Marrow Transplantation; Neoplasms; Hematologic Diseases; Leukemia, Myeloid

Keywords

Peer to Peer; Psychosocial Support; Caregivers

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Number of participants included from eligible family caregivers

  Up to 2 years

• Adherence to intervention

  Number of weeks completed out of planned weeks of intervention

  up to 24 weeks

• Emotional reactions (quality of contacts)

  Registration on descriptive data on content of contacts with project team members (primary investigator/project psychologist/project nurse)

  up to 24 weeks

• Emotional reactions (numbers of contacts)

  Registration on numbers of contacts with project team members (primary investigator/project psychologist/project nurse)

  up to 24 weeks

Secondary Outcomes (9)

• Depression

  Change measures (baseline, 12 weeks, 24 weeks)

• Anxiety

  Change measures (baseline, 12 weeks, 24 weeks)

• Sleep

  Change measures (baseline, 12 weeks, 24 weeks)

• Health-related quality of life

  Change measures (baseline, 12 weeks, 24 weeks)

• Self-efficacy

  Change measures (baseline, 12 weeks, 24 weeks)

Study Arms (1)

Family Caregiver Ambassador Support

EXPERIMENTAL

Intervention group: caregivers of newly diagnosed patients (n=30), former family caregivers as ambassadors (n=20)

Other: Family Caregiver Ambassador Support

Interventions

Family Caregiver Ambassador Support OTHER

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

Family Caregiver Ambassador Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

Location

Related Publications (2)

• Noerskov KH, Nielsen IH, Rahbaek ES, Halbro S, Mortensen AO, Overgaard UM, Piil K, Jarden M. Implementation and Evaluation of Peer Ambassador Support to Patients Newly Diagnosed With Hematological Cancer and Their Caregivers. Nurs Res Pract. 2025 Apr 28;2025:4528051. doi: 10.1155/nrp/4528051. eCollection 2025.

  PMID: 40330711 DERIVED

• Husted Nielsen I, Piil K, Tolver A, Gronbaek K, Kjeldsen L, Jarden M. Family caregiver ambassador support for caregivers of patients with newly diagnosed hematological cancer: a feasibility study. Support Care Cancer. 2022 Aug;30(8):6923-6935. doi: 10.1007/s00520-022-07089-0. Epub 2022 May 11.

  PMID: 35543814 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma; Neoplasms; Hematologic Diseases; Leukemia, Myeloid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases; Leukemia

Study Officials

• Mary Jarden, ph.d.

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Ph.D.student

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: October 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)