Multiple Myeloma Clinical Trial
Official title:
Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease (FAM CARE) - a Feasibility Study
Verified date | February 2022 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | December 1, 2021 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen | Østerbro |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rate | Number of participants included from eligible family caregivers | Up to 2 years | |
Primary | Adherence to intervention | Number of weeks completed out of planned weeks of intervention | up to 24 weeks | |
Primary | 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 | |
Primary | 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 | Depression | Measured with the Hospital Anxiety and Depression Scale (HADS) | Change measures (baseline, 12 weeks, 24 weeks) | |
Secondary | Anxiety | Measured with the Hospital Anxiety and Depression Scale (HADS) | Change measures (baseline, 12 weeks, 24 weeks) | |
Secondary | Sleep | Measured with the Pittsburgh Sleep Quality Index (PSQI) | Change measures (baseline, 12 weeks, 24 weeks) | |
Secondary | Health-related quality of life | Measured with the Short form-36 (SF-36) | Change measures (baseline, 12 weeks, 24 weeks) | |
Secondary | Self-efficacy | Measured with the General Self-Efficacy Scale questionnaire. Scale ranges with total scores (higher scores indicating better self-efficacy) | Change measures (baseline, 12 weeks, 24 weeks) | |
Secondary | Caregiver roles and responsibilities | Measured with the Caregiver Roles and Responsibilities Scale (CRRS) questionnaire measuring cancer impact on the lives of caregivers, each subscale provided by total scores | Change measures (baseline, 12 weeks, 24 weeks) | |
Secondary | Number of contacts between family caregiver and ambassador | Measured by the total number of contacts during the planned weeks of intervention. | Up to 12 weeks | |
Secondary | Length of contacts between family caregiver and ambassador | Measured by the total time of contacts during the planned weeks of | Up to 12 weeks | |
Secondary | Thematic content of the contacts between family caregiver and ambassador | Measured by ambassadors registrations and descriptions of thematic content of the contacts with the family caregiver | Up to 12 weeks |
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