Cancer SurvivorsNCT05780411
Cancer Survivorship in Hematologic Malignancies
An observational study of Cancer Survivors, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- questionnaire
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- a. Inclusion criteria:
- 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.
Who cannot join
- History of psychiatric disorders. b) Having other concomitant haematological diseases or solid neoplasm or relapse or other chronic disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University
Asyut, 71515
Roaa M Saleh, MD, 00201010617778, roaasalh043@gmail.com
Zain E Ahmed, MD, PhD, 00201115596820, Drzain73@yahoo.com
About this study
Official title: 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
Read the 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.
- Conditions
- Cancer Survivors
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
The symptom related checklist questionnaire, Quality of life questionnaire, Coping strategies questionnaire, Distress thermometer
| Study group | Role | What they receive |
|---|---|---|
| Myloid group | Patients diagnosed as Multiple Myeloma, treated, and not in relapse Receives: Other: questionnaire | |
| Lymphoid group | Patients diagnosed as having lymphoma, treated, and not in relapse Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of cancer survivor syndrome (CSS)
Estimate the incidence of cancer survivor syndrome (CSS) in adult Egyptian patients with hematological neoplasm neoplasms (HN)
Measured: 2 years
Secondary outcomes (3)
Asses the risk factors of CSS
Asses the risk factors of CSS in adult Egyptian patients with hematological neoplasm neoplasms (HN)
Measured: 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)
Measured: 2 years
Exploring coping strategies
To explore coping strategies of adult Egyptian patients with hematological neoplasm neoplasms (HN) in CSS.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roaa Mohammed Mohammed Saleh, Assiut University
- Investigators
- Safaa AA Khaled, MD, PhD, Study director, Professor, Department of Internal Medicine, Assiut UniversityZain E Ahmed, MD, PhD, Study chair, Professor, Department of Internal Medicine, Assiut UniversityRoaa M Saleh, MD, Principal investigator, Resident Doctor, Department of Internal Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780411
- Sponsor's protocol ID
- Cancer survivor syndrome
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 10404478Albrecht 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.
PubMed 23002383Grassi 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.
PubMed 29259774
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Study of Cancer Survivor Syndrome in Adult Egyptian Patients With Hematological Neoplasms
- ClinicalTrials.gov ID
- NCT05780411
- Acronym / sponsor ID
- Cancer survivor syndrome
- Conditions
- Cancer Survivors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myloid group | – | Other: questionnairePatients diagnosed as Multiple Myeloma, treated, and not in relapse |
| Lymphoid group | – | Other: questionnairePatients diagnosed as having lymphoma, treated, and not in relapse |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- a. Inclusion criteria:
Key exclusion criteria (1 listed)
- History of psychiatric disorders. b) Having other concomitant haematological diseases or solid neoplasm or relapse or other chronic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireThe symptom related checklist questionnaire, Quality of life questionnaire, Coping strategies questionnaire, Distress thermometer | Other | Lymphoid group, Myloid group |
Primary outcome
The incidence of cancer survivor syndrome (CSS)
Time frame: 2 years
Estimate the incidence of cancer survivor syndrome (CSS) in adult Egyptian patients with hematological neoplasm neoplasms (HN)
3 secondary outcomes
Asses the risk factors of CSS
Time frame: 2 years
Study the effect of CSS on quality of life
Time frame: 2 years
Exploring coping strategies
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Background: PubMed 10404478Hann 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.
- Background: PubMed 23002383Albrecht 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.
- Background: PubMed 29259774Grassi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safaa AA Khaled, MD, PhD study director
Professor, Department of Internal Medicine, Assiut University
Zain E Ahmed, MD, PhD study chair
Professor, Department of Internal Medicine, Assiut University
Roaa M Saleh, MD principal investigator
Resident Doctor, Department of Internal Medicine, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Survivors, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roaa M Saleh, MD (00201010617778, roaasalh043@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of cancer survivor syndrome (CSS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05780411, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.