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

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.

Study Overview

• Status: Terminated
• Conditions: Allograft; Post-allograft Relapse
• Intervention / Treatment: Other: Data collection (Prior and planned treatments, allograft)

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 Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

• Study Contact: Name: Denis Guyotat, PhD; Phone Number: +33 04 77 91 70 00; Email: denis.guyotat@chu-st-etienne.fr
• Study Contact Backup: Name: Elisabeth Daguenet, PhD; Phone Number: +33 04 77 91 70 00; Email: elisabeth.daguenet@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU DE SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hematological patients who underwent allograft and are being diagnosed with relapse (molecular or clinical relapse)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Denis Guyotat, PhD, CHU DE SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 4, 2022
• Study Completion (Actual): June 4, 2022

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: relapse; allograft; hematology; psychological impact; locus of control
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 2021-1101; 2021-A02882-39 (Other Identifier: Agence Nationale de Sécurité des Médicaments et des produits de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No