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

Rehabilitation Clinical Trial

— HAPPY  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04798495
• Other study ID #: HAPPY-1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: December 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rehabilitation
• Stem Cell Transplantation

Intervention

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.

Locations

Country	Name	City	State
Denmark	Dep. of Hem. Aarhus Universitetshospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Number of patients who accepted to participate in the study out of patients treated with non-myeloablative allogeneic haematopoietic stem cell transplantation	Baseline - 6-month follow-up
Primary	Attrition and reasons for drop out	Number of drop-outs of patients participating in the study	Baseline - 6-month follow-up
Primary	Exposure to physical exercise training per patient	The percentage of physical exercise training used by the patients when he/she was at the hospital and reason(s) for non-participation	Baseline - 6-month follow-up
Primary	Exposure to motivating interviewing per patient	The percentage of motivating interviewing used by the patients out all planned, and reason(s) for non-participation	Baseline - 6-month follow-up
Primary	Exposure to group sessions topics together with fellow patients and relatives per patient	The percentage of group sessions with different topics used by the patients out all planned, and reason(s) for non-participation	Baseline - 6-month follow-up
Primary	Exposure to nutritional counselling per patient	The percentage of nutritional counselling used by the patients out of planned, and reason(s) for non-participation	Baseline - 6-month follow-up
Primary	Exposure to digital physical exercise programme per patient	The percentage usage of the digital exercise programme out of possible/planned digital exercise trainings, and reason(s) for non-participation	Baseline - 6-month follow-up
Primary	Exposure to phone calls to patients staying at home	The percentage use of phone calls by patients while they stay at home, and reason(s) for unused	Baseline - 6-month follow-up
Primary	Exposure to individual dialogues	The percentage of individual dialogues with fixed subjects used by the patients out all planned, and reason(s) for non-participation	Baseline - 6-month follow-up
Primary	Adverse Events	The number of adverse events related to the intervention	Baseline-1-year follow-up
Secondary	Fidelity of physical exercise training	The percentage of physical exercise trainings delivered as planned, and reason(s) for cancellation	Baseline - 6-month follow-up
Secondary	Fidelity of motivating interviewing	The percentage of motivating interviewing delivered as planned, and reason(s) for cancellation	Baseline - 6-month follow-up
Secondary	Fidelity of individual dialogues	The percentage of individual dialogues with fixed subjects delivered as planned, and reason(s) for cancellation	Baseline - 6-month follow-up
Secondary	Fidelity of group sessions	The percentage of group sessions with different topics and exchange of experiences delivered as planned, and reason(s) for cancellation	Baseline - 6-month follow-up
Secondary	Fidelity of nutritional counselling	The percentage of nutritional counselling delivered out of planned, and reason(s) for cancellation	Baseline - 6-month follow-up
Secondary	Fidelity of the digital exercise programme	The percentage delivery of the digital exercise programme out of planned digital exercise trainings, and reason(s) for cancellation	Baseline - 6-month follow-up
Secondary	Fidelity of delivered phone calls	The percentage of delivered phone calls to patients at home, , and reason(s) for cancellation	Baseline - 6-month follow-up
Secondary	Practicability of questionnaires and physical tests	Percentage of questionnaires and physical tests performed out of possible questionnaires and physical tests, and reason(s) for delay or cancellation	Baseline-1-year follow-up