Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease (FAM CARE) - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
Aim: To investigate whether a Family Caregiver Support Model intervention (FAM-CARE) is feasible and safe, and the impact on the caregiving role and psychosocial wellbeing in family caregivers of newly diagnosed patients with hematological malignancies, and former caregivers (family caregiver ambassadors).
Design and Methods: This study is a one arm feasibility 12-week intervention trial including family caregivers (FC) (n=30) and family caregiver ambassadors (FCA)(n=20).
Recruitment: FC will be recruited at the Department of Hematology, Rigshospitalet (RH). Eligible family caregivers will receive oral and written information on the project from main investigator Iben Husted Nielsen (IHN) within four weeks from the patients' diagnosis. Due to ethical considerations and data protection guidelines patients of eligible caregivers will be approached by IHN with permission to contact their caregivers before approaching them. Family caregivers will be given information on the study and the opportunity to raise questions and concerns and time to consider before enrollment.
FCA will be recruited voluntarily from the Department of Hematology, RH and patient associations (LyLe, Myeloma). The FCA is screened by IHN to assess their appropriateness for the intervention with interview questions regarding their motivation, availability, and vulnerability. They will be asked to sign a confidentiality commitment. The FCA will be informed that they must provide transportation but will receive a monetary incentive for their participation. Further FCA will be asked to provide information regarding age, gender, interests, work, education and social conditions and family role in order to match with the FC. FC and FCA will be matched according to their preferences i.e. patient diagnosis, age, gender and other factors that might create a mutual understanding and ease communication. Given the preferences cannot be granted, the FC and FCA will be involved in the decision.
FAM CARE Intervention: The intervention consists of individual support provided by the FCA to the FC, with minimum four face-to-face meetings between the FC and FCA, and with ad hoc telephone and/or email contact based on the FC's individual needs, and one follow-up telephone contact at 3 months. The place of meeting and purpose of each face-to-face meeting is agreed upon by the FC and FCA. The FCA will follow one FC at a time, however at the end of the 12- week period the FCA can choose to follow a new FC. Upon the first meeting and expectation agreement will be discussed between the FC and FCA. During the intervention the FCA will document the frequency of meetings, duration, place, content and quality of the interactions between FC and FCA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Recruitment rate
时间窗: Up to 2 years
Number of participants included from eligible family caregivers
Adherence to intervention
时间窗: up to 24 weeks
Number of weeks completed out of planned weeks of intervention
Emotional reactions (numbers of contacts)
时间窗: up to 24 weeks
Registration on numbers of contacts with project team members (primary investigator/project psychologist/project nurse)
Emotional reactions (quality of contacts)
时间窗: up to 24 weeks
Registration on descriptive data on content of contacts with project team members (primary investigator/project psychologist/project nurse)
次要结局
- Anxiety(Change measures (baseline, 12 weeks, 24 weeks))
- Caregiver roles and responsibilities(Change measures (baseline, 12 weeks, 24 weeks))
- Self-efficacy(Change measures (baseline, 12 weeks, 24 weeks))
- Number of contacts between family caregiver and ambassador(Up to 12 weeks)
- Depression(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))
- Length of contacts between family caregiver and ambassador(Up to 12 weeks)
- Thematic content of the contacts between family caregiver and ambassador(Up to 12 weeks)
研究者
Iben Husted Nielsen
Principal Investigator, Ph.D.student
Rigshospitalet, Denmark