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

November 2, 2021 updated by: Aarhus University Hospital

Return to Everyday Life After Non-myeloablative Allogeneic Haematopoietic Stem Cell Transplantation; Feasibility and Participants' Perspectives of a Targeted Multimodal Interdisciplinary Rehabilitation Programme (HAPPY)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Dep. of Hem. Aarhus Universitetshospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HAPPY
Single arm longitudinal design.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Baseline - 6-month follow-up
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
Time Frame: Baseline - 6-month follow-up
Number of drop-outs of patients participating in the study
Baseline - 6-month follow-up
Exposure to physical exercise training per patient
Time Frame: Baseline - 6-month follow-up
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
Time Frame: Baseline - 6-month follow-up
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
Time Frame: Baseline - 6-month follow-up
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
Time Frame: Baseline - 6-month follow-up
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
Time Frame: Baseline - 6-month follow-up
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
Time Frame: Baseline - 6-month follow-up
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
Time Frame: Baseline - 6-month follow-up
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
Time Frame: Baseline-1-year follow-up
The number of adverse events related to the intervention
Baseline-1-year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fidelity of physical exercise training
Time Frame: Baseline - 6-month follow-up
The percentage of physical exercise trainings delivered as planned, and reason(s) for cancellation
Baseline - 6-month follow-up
Fidelity of motivating interviewing
Time Frame: Baseline - 6-month follow-up
The percentage of motivating interviewing delivered as planned, and reason(s) for cancellation
Baseline - 6-month follow-up
Fidelity of individual dialogues
Time Frame: Baseline - 6-month follow-up
The percentage of individual dialogues with fixed subjects delivered as planned, and reason(s) for cancellation
Baseline - 6-month follow-up
Fidelity of group sessions
Time Frame: Baseline - 6-month follow-up
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
Fidelity of nutritional counselling
Time Frame: Baseline - 6-month follow-up
The percentage of nutritional counselling delivered out of planned, and reason(s) for cancellation
Baseline - 6-month follow-up
Fidelity of the digital exercise programme
Time Frame: Baseline - 6-month follow-up
The percentage delivery of the digital exercise programme out of planned digital exercise trainings, and reason(s) for cancellation
Baseline - 6-month follow-up
Fidelity of delivered phone calls
Time Frame: Baseline - 6-month follow-up
The percentage of delivered phone calls to patients at home, , and reason(s) for cancellation
Baseline - 6-month follow-up
Practicability of questionnaires and physical tests
Time Frame: Baseline-1-year follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aarhus University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Astrid Lindman, Aarhus Universitetshospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HAPPY-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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