Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04039100
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2019-07-29
Brief Title:
Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease FAM CARE - a Feasibility Study
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n30 and family caregiver ambassadors N20 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 andor 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
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 n30 and family caregiver ambassadors N20 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 andor 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
Detailed Description:
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 n30 and family caregiver ambassadors FCAn20
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 ie 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 andor email contact based on the FCs 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
Recruited FCAs will receive a six-hour group education and training program prior to interacting with FC The training program include important and relevant actions and information on the role as ambassador communication skills with emphasis on active listening and discussion about volunteering and how to maintain appropriate boundaries to ensure that FCA are aware of their role as listeners who share their experiences only when solicited by the FC The training will be organized by IHN and a project nurse and carried out by IHN the project nurse and a project psychologist To secure the safety of FCA during the intervention they will be offered to attend support meetings organized by IHN and the project psychologist to process and share their experiences with being an ambassador Support meetings will be held every second month and FCA can request individual supervision from the project psychologist during the intervention Any severe adverse events will be documented and acted upon
Outcome measures and data collection Data are collected by patient reported outcome measures PROM as self-reported questionnaires completed by FC electronically prior to intervention post intervention 12-weeks and at 3-month follow-up PROM is completed by FCA prior to intervention and at post intervention 12 weeks Socio-demographic data are collected by questionnaire At the end of the 3-months follow-up focus group interviews with FC and FCA will be conducted on their experiences
Design and Methods This study is a one arm feasibility 12-week intervention trial including family caregivers FC n30 and family caregiver ambassadors FCAn20
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 ie 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 andor email contact based on the FCs 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
Recruited FCAs will receive a six-hour group education and training program prior to interacting with FC The training program include important and relevant actions and information on the role as ambassador communication skills with emphasis on active listening and discussion about volunteering and how to maintain appropriate boundaries to ensure that FCA are aware of their role as listeners who share their experiences only when solicited by the FC The training will be organized by IHN and a project nurse and carried out by IHN the project nurse and a project psychologist To secure the safety of FCA during the intervention they will be offered to attend support meetings organized by IHN and the project psychologist to process and share their experiences with being an ambassador Support meetings will be held every second month and FCA can request individual supervision from the project psychologist during the intervention Any severe adverse events will be documented and acted upon
Outcome measures and data collection Data are collected by patient reported outcome measures PROM as self-reported questionnaires completed by FC electronically prior to intervention post intervention 12-weeks and at 3-month follow-up PROM is completed by FCA prior to intervention and at post intervention 12 weeks Socio-demographic data are collected by questionnaire At the end of the 3-months follow-up focus group interviews with FC and FCA will be conducted on their experiences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None