RElapse After Allograft: Link Between LoCus of Control and QualiTy of Life

NCT ID: NCT05258929

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-06-04

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.

Conditions

Allograft; Post-allograft Relapse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Hematological patients who underwent allograft

Patients who underwent allograft and then relapsed

Data collection (Prior and planned treatments, allograft)

Intervention Type: OTHER

MHLC questionnaire (Multidimensional Health Locus of Control) when a novel therapeutic strategy is set up

Interventions

Data collection (Prior and planned treatments, allograft)

MHLC questionnaire (Multidimensional Health Locus of Control) when a novel therapeutic strategy is set up

Intervention Type: OTHER

Other Intervention Names

Levenson Scale and QLQ-C30 at relapse

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis Guyotat, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2021-A02882-39

Identifier Type: OTHER

Identifier Source: secondary_id

2021-1101

Identifier Type: -

Identifier Source: org_study_id