Clinical trial NCT05780411: Cancer Survivorship in Hematologic Malignancies
Official title: A Comprehensive Study of Cancer Survivor Syndrome in Adult Egyptian Patients With Hematological Neoplasms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Survivors
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of cancer survivor syndrome (CSS)
timeFrame: 2 years
Secondary outcomes:
measure: Asses the risk factors of CSS
timeFrame: 2 years
measure: Study the effect of CSS on quality of life
timeFrame: 2 years
measure: Exploring coping strategies
timeFrame: 2 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Professor, Department of Internal Medicine, Assiut University
name: Safaa AA Khaled, MD, PhD
role: STUDY_DIRECTOR
affiliation: Professor, Department of Internal Medicine, Assiut University
name: Zain E Ahmed, MD, PhD
role: STUDY_CHAIR
affiliation: Resident Doctor, Department of Internal Medicine, Assiut University
name: Roaa M Saleh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.