NCT05780411

Brief Summary

General objective: to improve care for haematological cancer survivors. This study will (i) Estimate the incidence of cancer survivor syndrome (CSS) in adult Egyptian patients with haematological neoplasms (HN). (ii) Asses the risk factors of CSS in patients with HN. (iii) Study the effect of CSS on quality of life in patients with HN. (iv) To explore coping strategies of patients with HN having CSS

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

March 10, 2023

Last Update Submit

March 10, 2023

Conditions

Cancer Survivors

Outcome Measures

Primary Outcomes (1)

  • The incidence of cancer survivor syndrome (CSS)

    Estimate the incidence of cancer survivor syndrome (CSS) in adult Egyptian patients with hematological neoplasm neoplasms (HN)

    2 years

Secondary Outcomes (3)

  • Asses the risk factors of CSS

    2 years

  • Study the effect of CSS on quality of life

    2 years

  • Exploring coping strategies

    2 years

Study Arms (2)

Myloid group

Patients diagnosed as Multiple Myeloma, treated, and not in relapse

Other: questionnaire

Lymphoid group

Patients diagnosed as having lymphoma, treated, and not in relapse

Other: questionnaire

Interventions

questionnaireOTHER

The symptom related checklist questionnaire, Quality of life questionnaire, Coping strategies questionnaire, Distress thermometer

Lymphoid groupMyloid group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer survivor syndrome patients with haematological malignancy divided into two groups: Group 1: Myeloid neoplasms. Group 2: Lymphoid neoplasms in remission. The questionnaires will be collected from January 2023 to January 2025 in the Department of Hematology from Assiut University Hospital. This study will be approved from the Committee on Human Experimentation of Assiut University

You may qualify if:

  • Age will be more than or equal 18 years old regardless with six.
  • Patients have been clinically diagnosed with haematological cancers.
  • Being Native Egyptian patients.

You may not qualify if:

  • History of psychiatric disorders. b) Having other concomitant haematological diseases or solid neoplasm or relapse or other chronic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (3)

  • Hann D, Winter K, Jacobsen P. Measurement of depressive symptoms in cancer patients: evaluation of the Center for Epidemiological Studies Depression Scale (CES-D). J Psychosom Res. 1999 May;46(5):437-43. doi: 10.1016/s0022-3999(99)00004-5.

    PMID: 10404478BACKGROUND

  • Albrecht TA, Rosenzweig M. Management of Cancer Related Distress in Patients with a Hematological Malignancy. J Hosp Palliat Nurs. 2012 Oct 1;14(7):462-468. doi: 10.1097/NJH.0b013e318268d04e.

    PMID: 23002383BACKGROUND

  • Grassi L, Spiegel D, Riba M. Advancing psychosocial care in cancer patients. F1000Res. 2017 Dec 4;6:2083. doi: 10.12688/f1000research.11902.1. eCollection 2017.

    PMID: 29259774BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Safaa AA Khaled, MD, PhD

    Professor, Department of Internal Medicine, Assiut University

    STUDY DIRECTOR

  • Zain E Ahmed, MD, PhD

    Professor, Department of Internal Medicine, Assiut University

    STUDY CHAIR

  • Roaa M Saleh, MD

    Resident Doctor, Department of Internal Medicine, Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roaa M Saleh, MD

CONTACT

00201010617778roaasalh043@gmail.com

Zain E Ahmed, MD, PhD

CONTACT

01115596820Drzain73@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 22, 2023

Study Start

April 1, 2023

Primary Completion

January 31, 2025

Study Completion

March 31, 2025

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)