Recruitment

Recruitment Status
Active, not recruiting

Summary

Conditions
  • Rehabilitation
  • Stem Cell Transplantation
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Background 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 associat...

Background 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 help this group of patients return to everyday life. Purpose The overall aim is to develop and evaluate the feasibility of a targeted multimodal interdisciplinary rehabilitation programme by involving patients undergoing NMA-HSCT. Method Three studies were planned in accordance with the theoretical framework of Complex Interventions. Study I 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 A feasibility study using a single arm pre-test post-test design. 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, VO2max, muscle power, body-composition, days at hospital, return to work and survival. A 6-month multimodal interdisciplinary rehabilitation programme was tested. The investigators used motivating interviewing technique, individual supervised physical exercise training, relaxation exercises, nutritional counselling and lessons for patients and relatives in small groups. To reach patients at home, the team phoned patients, who were also given tablets with access to the project's homepage and an interactive physical exercise programme. Feasibility parameters were acceptability, practicality, safety and programme adherence. Study III 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 programme's influence on handling everyday life, during and after NMA-HSCT. Perspectives The project contributes with knowledge about the feasibility of a rehabilitation programme targeted at a vulnerable group of chronic cancer patients with rare diseases. The study 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.

Tracking Information

NCT #
NCT04798495
Collaborators
Not Provided
Investigators
Principal Investigator: Astrid Lindman Aarhus Universitetshospital