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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05780411
Other study ID # Cancer survivor syndrome
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date March 31, 2025

Study information

Verified date March 2023
Source Assiut University
Contact Roaa M Saleh, MD
Phone 00201010617778
Email roaasalh043@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date March 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Asses the risk factors of CSS Asses the risk factors of CSS in adult Egyptian patients with hematological neoplasm neoplasms (HN) 2 years
Secondary 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
Secondary Exploring coping strategies To explore coping strategies of adult Egyptian patients with hematological neoplasm neoplasms (HN) in CSS. 2 years
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