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

Study Overview
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Brief Summary
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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
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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.

Official Title
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RElapse After Allograft: Link Between LoCus of Control and QualiTy of Life: REACT Study

Conditions
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Allograft, Post-allograft Relapse

Intervention / Treatment
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* Other: Data collection (Prior and planned treatments, allograft)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hematological patients who underwent allograft<br>Patients who underwent allograft and then relapsed | Other: Data collection (Prior and planned treatments, allograft)<br>* MHLC questionnaire (Multidimensional Health Locus of Control) when a novel therapeutic strategy is set up<br>* Other names: Levenson Scale and QLQ-C30 at relapse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematology, allograft, relapse, psychological impact, locus of control