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

NCT04798495 | Completed

• 1 other identifier: HAPPY-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplantation; Rehabilitation

Outcome Measures

Primary Outcomes (10)

• 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

• Attrition and reasons for drop out

  Number of drop-outs of patients participating in the study

  Baseline - 6-month follow-up

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Adverse Events

  The number of adverse events related to the intervention

  Baseline-1-year follow-up

Secondary Outcomes (8)

• Fidelity of physical exercise training

  Baseline - 6-month follow-up

• Fidelity of motivating interviewing

  Baseline - 6-month follow-up

• Fidelity of individual dialogues

  Baseline - 6-month follow-up

• Fidelity of group sessions

  Baseline - 6-month follow-up

• Fidelity of nutritional counselling

  Baseline - 6-month follow-up

Study Arms (1)

HAPPY

EXPERIMENTAL

Single arm longitudinal design.

Other: Multimodal interdisciplinary rehabilitation programme (HAPPY)

Interventions

Multimodal interdisciplinary rehabilitation programme (HAPPY) OTHER

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.

HAPPY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Dep. of Hem. Aarhus Universitetshospital

Aarhus, Denmark

Location

Study Officials

• Astrid Lindman

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 15, 2021
• Study Start: September 1, 2018
• Primary Completion: January 15, 2021
• Study Completion: July 1, 2021
• Last Updated: November 10, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)