Clinical trial NCT04798495: Feasibility of a Rehabilitation Programme Targeted Patients Treated With Non-myeloablative Stem Cell Transplantation
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stem Cell Transplantation
Rehabilitation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 (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.

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 project's 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 programme's 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.

Eligibility criteria: Inclusion Criteria:

* Patients were accepted for NMA-HSCT
* ≥ 18 years
* able to read and understand Danish and to follow the study protocol.

Exclusion Criteria:

* psychological diagnosis
* contra-indications for progressive exercise training
* inability to walk or stand
* instable bone lesions
* severe neurological deficiencies
* severe cardiac or cardio vascular diseases, severe pulmonary global insufficiency.

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline - 6-month follow-up
measure: Attrition and reasons for drop out
timeFrame: Baseline - 6-month follow-up
measure: Exposure to physical exercise training per patient
timeFrame: Baseline - 6-month follow-up
measure: Exposure to motivating interviewing per patient
timeFrame: Baseline - 6-month follow-up
measure: Exposure to group sessions topics together with fellow patients and relatives per patient
timeFrame: Baseline - 6-month follow-up
measure: Exposure to nutritional counselling per patient
timeFrame: Baseline - 6-month follow-up
measure: Exposure to digital physical exercise programme per patient
timeFrame: Baseline - 6-month follow-up
measure: Exposure to phone calls to patients staying at home
timeFrame: Baseline - 6-month follow-up
measure: Exposure to individual dialogues
timeFrame: Baseline - 6-month follow-up
measure: Adverse Events
timeFrame: Baseline-1-year follow-up
Secondary outcomes:
measure: Fidelity of physical exercise training
timeFrame: Baseline - 6-month follow-up
measure: Fidelity of motivating interviewing
timeFrame: Baseline - 6-month follow-up
measure: Fidelity of individual dialogues
timeFrame: Baseline - 6-month follow-up
measure: Fidelity of group sessions
timeFrame: Baseline - 6-month follow-up
measure: Fidelity of nutritional counselling
timeFrame: Baseline - 6-month follow-up
measure: Fidelity of the digital exercise programme
timeFrame: Baseline - 6-month follow-up
measure: Fidelity of delivered phone calls
timeFrame: Baseline - 6-month follow-up
measure: Practicability of questionnaires and physical tests
timeFrame: Baseline-1-year follow-up
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dep. of Hem. Aarhus Universitetshospital
Study officials:
affiliation: Aarhus University Hospital
name: Astrid Lindman
role: PRINCIPAL_INVESTIGATOR
References: