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Feasibility of a Rehabilitation Programme Targeted Patients Treated With Non-myeloablative Stem Cell Transplantation

NCT04798495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-11-10

No results posted yet for this study

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 (N=30) 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 programme's 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.

Conditions

  • Stem Cell Transplantation
  • Rehabilitation

Interventions

OTHER

Multimodal interdisciplinary rehabilitation programme (HAPPY)

A 6-month multimodal interdisciplinary rehabilitation programme abbreviated HAPPY was tested. The programme consisted of motivating interviewing technique, individual dialogues with fixed subjects, 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 project's homepage and a digital physical exercise programme.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Astrid Lindman · Aarhus University Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2021-01-15
Completion
2021-07-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798495 on ClinicalTrials.gov