Clinical trial NCT05258929: RElapse After Allograft: Link Between LoCus of Control and QualiTy of Life
Official title: RElapse After Allograft: Link Between LoCus of Control and QualiTy of Life: REACT Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Allograft
Post-allograft Relapse
Keywords: hematology
allograft
relapse
psychological impact
locus of control
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hematological patients who underwent allograft and are being diagnosed with relapse (molecular or clinical relapse)

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Major patient who has been informed about the study;
* Allografted patient with molecular or clinical relapse.

Exclusion Criteria:

* Legal incapacity or limited capacity ; Medical or psychological incapacity or limited capacity;
* Not able to understand and complete surveys.

Primary outcomes:
measure: Correlation between the locus of control and the perception of the patient
timeFrame: 1 month
Secondary outcomes:
measure: Correlation between the quality-of-life and the locus of control
timeFrame: 1 month
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Denis Guyotat, PhD
role: PRINCIPAL_INVESTIGATOR
References: