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

NCT05258929 | Terminated

• 2 other identifiers: 2021-11012021-A02882-39
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Allograft; Post-allograft Relapse

Keywords

hematology; allograft; relapse; psychological impact; locus of control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between the quality-of-life and the locus of control

  1 month

Study Arms (1)

Hematological patients who underwent allograft

Patients who underwent allograft and then relapsed

Other: Data collection (Prior and planned treatments, allograft)

Interventions

Data collection (Prior and planned treatments, allograft) OTHER

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

Also known as: Levenson Scale and QLQ-C30 at relapse

Hematological patients who underwent allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Recurrence

Interventions

Data Collection; Lead; Transplantation, Homologous

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Metals, Heavy; Elements; Inorganic Chemicals; Metals; Transplantation; Surgical Procedures, Operative

Study Officials

• Denis Guyotat, PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 28, 2022
• Study Start: March 1, 2022
• Primary Completion: June 4, 2022
• Study Completion: June 4, 2022
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)