AllograftREACTNCT05258929
RElapse After Allograft: Link Between LoCus of Control and QualiTy of Life
An observational study of Allograft and Post-allograft Relapse, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Allogeneic hematopoietic transplantation (AlloHCT) is a robust therapeutic that is used as a consolidation strategy in a number of haematological cancers. It provides durable responses as compared to chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allograft, Post-allograft Relapse
- What is being tested?
- Data collection (Prior and planned treatments, allograft)
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 4 Jun 2022
- Phase
- Observational
- 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
Study population: Hematological patients who underwent allograft and are being diagnosed with relapse (molecular or clinical relapse)
Who may be able to join
- Major patient who has been informed about the study;
- Allografted patient with molecular or clinical relapse.
Who cannot join
- Legal incapacity or limited capacity ; Medical or psychological incapacity or limited capacity;
- Not able to understand and complete surveys.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RElapse After Allograft: Link Between LoCus of Control and QualiTy of Life: REACT Study
Allogeneic hematopoietic transplantation (AlloHCT) is a robust therapeutic that is used as a consolidation strategy in a number of haematological cancers. It provides durable responses as compared to chemotherapy alone. Despite the potential of the graft-versus-tumor effect that is driven by AlloHCT, relapse after AlloHCT remains common. Yet, the psychological impact of relapse after allograft is poorly appreciated.
Read the detailed description
For patients with hematological cancers of poor prognosis (acute myeloid leukemia, myelodysplastic syndromes…), proceeding to allogeneic hematopoietic transplantation (AlloHCT) is the definitive curative approach. While AlloHCT is an invasive procedure, patients experience social isolation and distressing symptoms when hospitalized. Indeed, patients often report high levels of anxiety and/or depression during hospitalization and upon discharge. A number of risk factors have been linked to psychological morbidity and their impact on post-AlloHCT relapse have been less investigated. Of note, the health locus of control may play a significant role in determining patients' health-related behaviors. The health locus of control is defined as the set of beliefs a person has about his or her personal influence on health, including an internal locus of control (i.e. personal actions or thoughts can affect outcomes) and an external locus of control (i.e. outcome is believed to be determined by powerful others: God, health professionals, chance…). In this context, the aim of the study REACT is to identify the types of locus of control in relapsed patients after AlloHCT and the possible association with current disease perception as well as further therapeutic strategies.
- Conditions
- Allograft, Post-allograft Relapse
- Being tested
- Data collection (Prior and planned treatments, allograft)
- Keywords
- hematology, allograft, relapse, psychological impact, locus of control
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection (Prior and planned treatments, allograft)Other
Also called Levenson Scale and QLQ-C30 at relapse
MHLC questionnaire (Multidimensional Health Locus of Control) when a novel therapeutic strategy is set up
| Study group | Role | What they receive |
|---|---|---|
| Hematological patients who underwent allograft | Patients who underwent allograft and then relapsed Receives: Other: Data collection (Prior and planned treatments, allograft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the locus of control and the perception of the patient
Multidimensional Health Locus of Control questionnaire with regards to the locus of control. The survey contains 18-items with 6-items for each of its three subscales: Internal, Chance and Powerful Others. Each item is scored on a 6-point, Likert-type, scale from 1 (Strongly Disagree) to 6 (Strongly Agree). Scores for each subscale reflect the total score for the corresponding 6 items, with subscales having a minimum score of 6 and maximum score of 36.
Measured: 1 month
Secondary outcomes (1)
Correlation between the quality-of-life and the locus of control
QLQ-C30 questionnaire with regards to the locus of control. The maximum score is 126, the minimum score is 30. More the score is, worst the health state is.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Mar 2022
- Primary completion4 Jun 2022
- Study completion4 Jun 2022
Why it stopped: low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllograftStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Guyotat, PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258929
- Sponsor's protocol ID
- 2021-1101
- Other IDs
- 2021-A02882-39
- Acronym
- REACT
- Status last verified
- Mar 2024
- First submitted
- 7 Feb 2022
- Last updated
- 4 Mar 2024
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RElapse After Allograft: Link Between LoCus of Control and QualiTy of Life: REACT Study
- ClinicalTrials.gov ID
- NCT05258929
- Acronym / sponsor ID
- REACT / 2021-1101
- Conditions
- Allograft, Post-allograft Relapse
- Keywords
- hematology, allograft, relapse, psychological impact, locus of control
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low inclusion rate
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 4 Jun 2022 (actual)
- Study completion
- 4 Jun 2022 (actual)
- First posted
- 28 Feb 2022 (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.
Allogeneic hematopoietic transplantation (AlloHCT) is a robust therapeutic that is used as a consolidation strategy in a number of haematological cancers. It provides durable responses as compared to chemotherapy alone. Despite the potential of the graft-versus-tumor effect that is driven by AlloHCT, relapse after AlloHCT remains common. Yet, the psychological impact of relapse after allograft is poorly appreciated.
Detailed description
For patients with hematological cancers of poor prognosis (acute myeloid leukemia, myelodysplastic syndromes…), proceeding to allogeneic hematopoietic transplantation (AlloHCT) is the definitive curative approach. While AlloHCT is an invasive procedure, patients experience social isolation and distressing symptoms when hospitalized. Indeed, patients often report high levels of anxiety and/or depression during hospitalization and upon discharge. A number of risk factors have been linked to psychological morbidity and their impact on post-AlloHCT relapse have been less investigated. Of note, the health locus of control may play a significant role in determining patients' health-related behaviors. The health locus of control is defined as the set of beliefs a person has about his or her personal influence on health, including an internal locus of control (i.e. personal actions or thoughts can affect outcomes) and an external locus of control (i.e. outcome is believed to be determined by powerful others: God, health professionals, chance…). In this context, the aim of the study REACT is to identify the types of locus of control in relapsed patients after AlloHCT and the possible association with current disease perception as well as further therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematological patients who underwent allograft | – | Other: Data collection (Prior and planned treatments, allograft)Patients who underwent allograft and then relapsed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hematological patients who underwent allograft and are being diagnosed with relapse (molecular or clinical relapse)
Key inclusion criteria (2 listed)
- Major patient who has been informed about the study;
- Allografted patient with molecular or clinical relapse.
Key exclusion criteria (2 listed)
- Legal incapacity or limited capacity ; Medical or psychological incapacity or limited capacity;
- Not able to understand and complete surveys.
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 |
|---|---|---|
| Data collection (Prior and planned treatments, allograft)Also: Levenson Scale and QLQ-C30 at relapseMHLC questionnaire (Multidimensional Health Locus of Control) when a novel therapeutic strategy is set up | Other | Hematological patients who underwent allograft |
Primary outcome
Correlation between the locus of control and the perception of the patient
Time frame: 1 month
Multidimensional Health Locus of Control questionnaire with regards to the locus of control. The survey contains 18-items with 6-items for each of its three subscales: Internal, Chance and Powerful Others. Each item is scored on a 6-point, Likert-type, scale from 1 (Strongly Disagree) to 6 (Strongly Agree). Scores for each subscale reflect the total score for the corresponding 6 items, with subscales having a minimum score of 6 and maximum score of 36.
1 secondary outcome
Correlation between the quality-of-life and the locus of control
Time frame: 1 month
Results and safety
The study was stopped early (reason given: low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- 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.
Denis Guyotat, PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allograft and Post-allograft Relapse, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 4 Mar 2024. 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 France. 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 was stopped early (reason given: low inclusion rate). Results are not available in the source record.
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?
Correlation between the locus of control and the perception of the patient (time frame: 1 month). 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 4 Mar 2024.