Cancer Survivorship in Hematologic Malignancies

A Comprehensive Study of Cancer Survivor Syndrome in Adult Egyptian Patients With Hematological Neoplasms

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Survivors
• Intervention / Treatment: Other: questionnaire

Detailed Description

According to the American Cancer Society the term cancer survivor refersto people who have no signs of cancer after finishing treatment, people receiving extended treatment over a longer period of time to control the cancer or reduce risk of its return, and people with advanced cancer. Most hematologic malignancies (HM) are incurable and typically follow unpredictable remitting-relapsing pathways associated with varying need for treatment, which may be distressing for patients. Distress symptoms and psychological disorders secondary to cancer have also been shown to have significant negative consequences for both the patient and the family.

Maladaptive coping and abnormal illness behavior have been associated with psychiatric conditions, with negative effects on adherence to treatment, health behavior, and quality of life (Grassi et al 2017). Moreover, an increased length of stay in the hospital and/or an increased time in rehabilitation have been found to be more common among patients showing psychiatric symptoms, especially depression, than those with normal adjustment to illness (Cordova et al 2017). Unfortunately, cancer-related distress is commonly underrecognized and subsequently undertreated especially for patients with HM in developing countries. Search in literature revealed several screening methods for the psychological consequences of cancer such as Distress Thermometer , Symptom related checklist questionnaire, Quality of life questionnaire, Coping strategies questionnaire. Also, guidelines for the management of psychological distress have been developed by several scientific cancer associations.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Roaa M Saleh, MD; Phone Number: 00201010617778; Email: roaasalh043@gmail.com
• Study Contact Backup: Name: Zain E Ahmed, MD, PhD; Phone Number: 01115596820; Email: Drzain73@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University
    • Contact: Roaa M Saleh, MD; Phone Number: 00201010617778; Email: roaasalh043@gmail.com
    • Contact: Zain E Ahmed, MD, PhD; Phone Number: 00201115596820; Email: Drzain73@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

• a. Inclusion criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Myloid group; Patients diagnosed as Multiple Myeloma, treated, and not in relapse	Other: questionnaire; The symptom related checklist questionnaire, Quality of life questionnaire, Coping strategies questionnaire, Distress thermometer
Lymphoid group; Patients diagnosed as having lymphoma, treated, and not in relapse	Other: questionnaire; The symptom related checklist questionnaire, Quality of life questionnaire, Coping strategies questionnaire, Distress thermometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asses the risk factors of CSS	Asses the risk factors of CSS in adult Egyptian patients with hematological neoplasm neoplasms (HN)	2 years
Study the effect of CSS on quality of life	Study the effect of CSS on quality of life in adult Egyptian patients with hematological neoplasm neoplasms (HN)	2 years
Exploring coping strategies	To explore coping strategies of adult Egyptian patients with hematological neoplasm neoplasms (HN) in CSS.	2 years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Safaa AA Khaled, MD, PhD, Professor, Department of Internal Medicine, Assiut University; Study Chair: Zain E Ahmed, MD, PhD, Professor, Department of Internal Medicine, Assiut University; Principal Investigator: Roaa M Saleh, MD, Resident Doctor, Department of Internal Medicine, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): January 31, 2025
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Cancer survivor syndrome

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