Stem Cell TransplantationHAPPYNCT04798495
Feasibility of a Rehabilitation Programme Targeted Patients Treated With Non-myeloablative Stem Cell Transplantation
A study testing Multimodal interdisciplinary rehabilitation programme (HAPPY) in people with Stem Cell Transplantation and Rehabilitation, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplantation, Rehabilitation
- What is being tested?
- Multimodal interdisciplinary rehabilitation programme (HAPPY)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were accepted for NMA-HSCT
- ≥ 18 years
- able to read and understand Danish and to follow the study protocol.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- Stem Cell Transplantation, Rehabilitation
- Being tested
- Multimodal interdisciplinary rehabilitation programme (HAPPY)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| HAPPY | Experimental | Single arm longitudinal design. Receives: Other: Multimodal interdisciplinary rehabilitation programme (HAPPY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of patients who accepted to participate in the study out of patients treated with non-myeloablative allogeneic haematopoietic stem cell transplantation
Measured: Baseline - 6-month follow-up
Attrition and reasons for drop out
Number of drop-outs of patients participating in the study
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline - 6-month follow-up
Adverse Events
The number of adverse events related to the intervention
Measured: Baseline-1-year follow-up
Secondary outcomes (8)
Fidelity of physical exercise training
The percentage of physical exercise trainings delivered as planned, and reason(s) for cancellation
Measured: Baseline - 6-month follow-up
Fidelity of motivating interviewing
The percentage of motivating interviewing delivered as planned, and reason(s) for cancellation
Measured: Baseline - 6-month follow-up
Fidelity of individual dialogues
The percentage of individual dialogues with fixed subjects delivered as planned, and reason(s) for cancellation
Measured: Baseline - 6-month follow-up
Fidelity of group sessions
The percentage of group sessions with different topics and exchange of experiences delivered as planned, and reason(s) for cancellation
Measured: Baseline - 6-month follow-up
Fidelity of nutritional counselling
The percentage of nutritional counselling delivered out of planned, and reason(s) for cancellation
Measured: Baseline - 6-month follow-up
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
Measured: Baseline - 6-month follow-up
Fidelity of delivered phone calls
The percentage of delivered phone calls to patients at home, , and reason(s) for cancellation
Measured: Baseline - 6-month follow-up
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
Measured: Baseline-1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Sep 2018
- Primary completion15 Jan 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Astrid Lindman, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798495
- Sponsor's protocol ID
- HAPPY-1
- Acronym
- HAPPY
- Status last verified
- Dec 2020
- First submitted
- 23 Feb 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04798495
- Acronym / sponsor ID
- HAPPY / HAPPY-1
- Conditions
- Stem Cell Transplantation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAPPY | Experimental | Other: Multimodal interdisciplinary rehabilitation programme (HAPPY)Single arm longitudinal design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients were accepted for NMA-HSCT
- ≥ 18 years
- able to read and understand Danish and to follow the study protocol.
Key exclusion criteria (6 listed)
- psychological diagnosis
- contra-indications for progressive exercise training
- inability to walk or stand
- instable bone lesions
- severe neurological deficiencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | HAPPY |
Primary outcome
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
Attrition and reasons for drop out
Time frame: Baseline - 6-month follow-up
Number of drop-outs of patients participating in the study
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
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
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
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
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
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
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
Adverse Events
Time frame: Baseline-1-year follow-up
The number of adverse events related to the intervention
8 secondary outcomes
Fidelity of physical exercise training
Time frame: Baseline - 6-month follow-up
Fidelity of motivating interviewing
Time frame: Baseline - 6-month follow-up
Fidelity of individual dialogues
Time frame: Baseline - 6-month follow-up
Fidelity of group sessions
Time frame: Baseline - 6-month follow-up
Fidelity of nutritional counselling
Time frame: Baseline - 6-month follow-up
Fidelity of the digital exercise programme
Time frame: Baseline - 6-month follow-up
Fidelity of delivered phone calls
Time frame: Baseline - 6-month follow-up
Practicability of questionnaires and physical tests
Time frame: Baseline-1-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid Lindman principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal interdisciplinary rehabilitation programme (HAPPY) in people with Stem Cell Transplantation and Rehabilitation, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline - 6-month follow-up). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.