Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798495
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2021-02-23
Brief Title:
Feasibility of a Rehabilitation Programme Targeted Patients Treated With Non-myeloablative Stem Cell Transplantation
Sponsor:
Aarhus University Hospital
Organization:
University of Aarhus
Study Overview
Official Title:
Return to Everyday Life After Non-myeloablative Allogeneic Haematopoietic Stem Cell Transplantation Feasibility and Participants Perspectives of a Targeted Multimodal Interdisciplinary Rehabilitation Programme HAPPY
Status:
COMPLETED
Status Verified Date:
2020-12
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:
HAPPY
Brief Summary:
Non-myeloablative allogeneic haematopoietic stem cell transplantation NMA-HSCT is associated with innumerable complications and side-effects and a high treatment-related mortality Maintaining quality of life physical and psychosocial functioning and participation in society is therefore challenging for patients undergoing treatment with NMA-HSCT This situation creates an urgent need for rehabilitation for patients to return to a meaningful everyday life and for knowledge about how to best help this group of patients return to everyday life
The project aims to develop and examine the feasibility and safety of a multimodal interdisciplinary rehabilitation programme targeted patients undergoing treatment with NMA-HSCT
Three studies are planned Study I is a qualitative interview study to get a profound insight into patients experiences and challenges after NMA-HSCT
Study II has a single arm longitudinal design with both a feasibility and an outcome component Patients N30 are consecutively recruited at the Department of Haematology Aarhus University Hospital Denmark and enrolled in the 6-month HAPPY programme as soon as the decision about NMA-HSCT is final Data is collected pre-NMA-HSCT at 3-month 6-month and 12-month after NMA-HSCT
Study III is a qualitative interview study where patients who participated in the rehabilitation programme evaluate the programmes influence on their return to everyday life
The project contributes with knowledge about the feasibility of a rehabilitation programme targeted at a vulnerable group of chronic cancer patients with rare diseases We will document the impact of an interdisciplinary intervention anchored in the hospital setting but aimed at reaching patients at home If the intervention enhances quality of life patient activation and functioning it may not only reduce the number of hospitalizations and use of healthcare services but may also allow more patients to maintain contact with the labour market and resume participation in society
The project aims to develop and examine the feasibility and safety of a multimodal interdisciplinary rehabilitation programme targeted patients undergoing treatment with NMA-HSCT
Three studies are planned Study I is a qualitative interview study to get a profound insight into patients experiences and challenges after NMA-HSCT
Study II has a single arm longitudinal design with both a feasibility and an outcome component Patients N30 are consecutively recruited at the Department of Haematology Aarhus University Hospital Denmark and enrolled in the 6-month HAPPY programme as soon as the decision about NMA-HSCT is final Data is collected pre-NMA-HSCT at 3-month 6-month and 12-month after NMA-HSCT
Study III is a qualitative interview study where patients who participated in the rehabilitation programme evaluate the programmes influence on their return to everyday life
The project contributes with knowledge about the feasibility of a rehabilitation programme targeted at a vulnerable group of chronic cancer patients with rare diseases We will document the impact of an interdisciplinary intervention anchored in the hospital setting but aimed at reaching patients at home If the intervention enhances quality of life patient activation and functioning it may not only reduce the number of hospitalizations and use of healthcare services but may also allow more patients to maintain contact with the labour market and resume participation in society
Detailed Description:
Rehabilitation is becoming increasingly important in the face of growing diversity and intensity of cancer treatment and so is treatment with haematopoietic stem cell transplantation from a donor Non-myeloablative allogeneic haematopoietic stem cell transplantation NMA-HSCT is associated with innumerable complications and side-effects and a high treatment-related mortality Maintaining quality of life physical and psychosocial functioning and participation in society is therefore challenging for patients undergoing treatment with NMA-HSCT This situation creates an urgent need for rehabilitation for patients to return to a meaningful everyday life and for knowledge about how to best support this group of patients return to everyday life
The overall aim is to develop and evaluate the feasibility of a targeted multimodal interdisciplinary rehabilitation programme by involving patients undergoing NMA-HSCT
Three studies were planned in accordance with the theoretical framework of Complex Interventions
Study I is a qualitative focus group interview study using the Interpretive Description methodology The purpose was to explore the experiences and perspectives of NMA-HSCT patients regarding their challenges and needs during their return to everyday life after HSCT transplantation
Study II has a single arm longitudinal design with both a feasibility component and an outcome component
The aim was to develop and to assess feasibility of the multimodal interdisciplinary rehabilitation programme HAPPY in patients with haematological cancers undergoing NMA-HSCT Furthermore to report health related quality of life Patient Activation Measurement cardiorespiratory capacity VO2peak muscle extension power lean body mass days at hospital return to work and survival A 6-month multimodal interdisciplinary rehabilitation programme was tested The programme consisted of motivating interviewing technique individual supervised physical exercise training relaxation exercises nutritional counselling and group sessions a combination of topics and exchange of experiences with patients and relatives To reach patients at home the team phoned patients who were also given tablets with access to the projects homepage and a digital physical exercise programme Feasibility parameters were acceptability exposure fidelity practicality safety
Study III is a qualitative interview study using the Interpretive Description methodology The aim was to explore patients experiences and perspectives on relevance and meaning of participating in the multimodal interdisciplinary rehabilitation programme HAPPY and the programmes influence on handling everyday life during and after NMA-HSCT
The project contributes with knowledge about the feasibility of a rehabilitation programme targeted at a vulnerable group of chronic cancer patients with rare diseases We will document the impact of an interdisciplinary intervention anchored in the hospital setting but aimed at reaching patients at home If the intervention enhances health related quality of life patient activation and functioning it may not only reduce the number of hospitalizations and use of healthcare services but may also allow more patients to maintain contact with the labour market and resume participation in society
The overall aim is to develop and evaluate the feasibility of a targeted multimodal interdisciplinary rehabilitation programme by involving patients undergoing NMA-HSCT
Three studies were planned in accordance with the theoretical framework of Complex Interventions
Study I is a qualitative focus group interview study using the Interpretive Description methodology The purpose was to explore the experiences and perspectives of NMA-HSCT patients regarding their challenges and needs during their return to everyday life after HSCT transplantation
Study II has a single arm longitudinal design with both a feasibility component and an outcome component
The aim was to develop and to assess feasibility of the multimodal interdisciplinary rehabilitation programme HAPPY in patients with haematological cancers undergoing NMA-HSCT Furthermore to report health related quality of life Patient Activation Measurement cardiorespiratory capacity VO2peak muscle extension power lean body mass days at hospital return to work and survival A 6-month multimodal interdisciplinary rehabilitation programme was tested The programme consisted of motivating interviewing technique individual supervised physical exercise training relaxation exercises nutritional counselling and group sessions a combination of topics and exchange of experiences with patients and relatives To reach patients at home the team phoned patients who were also given tablets with access to the projects homepage and a digital physical exercise programme Feasibility parameters were acceptability exposure fidelity practicality safety
Study III is a qualitative interview study using the Interpretive Description methodology The aim was to explore patients experiences and perspectives on relevance and meaning of participating in the multimodal interdisciplinary rehabilitation programme HAPPY and the programmes influence on handling everyday life during and after NMA-HSCT
The project contributes with knowledge about the feasibility of a rehabilitation programme targeted at a vulnerable group of chronic cancer patients with rare diseases We will document the impact of an interdisciplinary intervention anchored in the hospital setting but aimed at reaching patients at home If the intervention enhances health related quality of life patient activation and functioning it may not only reduce the number of hospitalizations and use of healthcare services but may also allow more patients to maintain contact with the labour market and resume participation in society
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