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

Allograft Clinical Trial

— REACT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05258929
• Other study ID #: 2021-1101
• Secondary ID: 2021-A02882-39
• Status: Terminated
• Start date: March 1, 2022
• Est. completion date: June 4, 2022

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 4, 2022
• Est. primary completion date: June 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allograft
• Recurrence

Intervention

Other:
• Data collection (Prior and planned treatments, allograft)
MHLC questionnaire (Multidimensional Health Locus of Control) when a novel therapeutic strategy is set up

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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