CancerNCT06702982
Virtual Support, Real Impact: Effectiveness of Tele-nursing in Alleviating Chemotherapy Symptoms Among Cancer Patients
A study testing tele-nursing educational program in people with Cancer and Chemotherapy Effect, run by Helwan University at 1 site in Egypt.
Trial summary
This quasi-experimental study evaluated a tele-nursing educational program's impact on improving the quality of life and managing chemotherapy-related symptoms in 74 adult cancer patients at Mansoura University Hospital in Egypt. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cancer, Chemotherapy Effect, Quality of Life (QOL)
- What is being tested?
- tele-nursing educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Aug 2024
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Diagnosed with cancer and receiving treatment at an outpatient chemotherapy center
- Age from 20 less than 60 years.
- Accept to participate in the study.
- Had smart phones linked with internet
- Educated and able to use Zoom and Telegram applications
Who cannot join
- • Having active, serious physical disease
- Patients with mental disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Support, Real Impact: the Effectiveness of Tele-nursing in Alleviating Chemotherapy Symptoms Among Cancer Patients; a Quasi-experimental Study
This quasi-experimental study evaluated a tele-nursing educational program's impact on improving the quality of life and managing chemotherapy-related symptoms in 74 adult cancer patients at Mansoura University Hospital in Egypt. Delivered via Telegram, the program involved weekly educational sessions, aiming to enhance symptom management and quality of life.
Read the detailed description
The study aimed to assess the effectiveness of a tele-nursing educational program in managing chemotherapy-related and cancer-related symptoms and improving the quality of life among adult cancer patients. Conducted at the Oncology Center at Mansoura University Hospital in Egypt, the study recruited 74 participants who completed structured interviews detailing their demographics, medical history, symptom severity (using the MDASI-A tool), and quality of life (using the QOL-ACD tool). The intervention, delivered via a Telegram group, included weekly educational sessions focused on managing chemotherapy symptoms. The sessions featured educational content and feedback, with outcomes measured through changes in symptom severity and quality of life scores before and after the intervention. This approach highlighted the program's potential to enhance patients' overall well-being and symptom management.
- Conditions
- Cancer, Chemotherapy Effect, Quality of Life (QOL)
- Being tested
- tele-nursing educational program
- Keywords
- chemotherpay, tele-nursing, quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tele-nursing educational programBehavioural
The intervention administered in this study was a tele-nursing educational program aimed at improving cancer patients' management of chemotherapy-related symptoms and enhancing their quality of life. The program was delivered via a Telegram group, which provided a platform for regular interaction between the patients and nursing staff. The educational content was designed to address common chemotherapy-related symptoms, such as nausea, fatigue, pain, and loss of appetite, and to provide guidance on managing these symptoms effectively.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled participants | Experimental | The intervention administered in this study was a tele-nursing educational program aimed at improving cancer patients' management of chemotherapy-related symptoms and enhancing their quality of life. The program was delivered via a Telegram group, which provided a platform for regular interaction between the patients and nursing staff. The educational content was designed to address common chemotherapy-related symptoms, such as nausea, fatigue, pain, and loss of appetite, and to provide guidance on managing these symptoms effectively. Receives: Behavioral: tele-nursing educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer-related and treatment-related symptoms
The M.D. Anderson Symptom Inventory Arabic Version (MDASI-A), adapted from Nejmi et al. (2010), was utilized to assess the severity of cancer-related and treatment-related symptoms in a manner accessible to Arabic-speaking patients. Designed in straightforward Arabic, the tool evaluates both the intensity of 13 core symptoms commonly experienced by cancer patients and their interference with daily functioning. This makes the MDASI-A comprehensive while remaining brief enough to avoid imposing a burden on respondents.
The MDASI-A employs a 0-2 numerical scale (Never = 0, Sometimes = 1, Always = 2), ensuring its usability even among less-educated individuals. It is also adaptable for telephone, computer, and other electronic methods of administration. Scores were converted to percentages to classify symptom intensity into three categories: low (<50%), average (50% to <75%), and high (≥75%) based on the method proposed by Daisuke and Makoto (2022).
Measured: 3 months
Secondary outcomes (1)
Quality of life for Cancer Patients
The Quality of Life Questionnaire for Cancer Patients Treated with Anticancer Drugs (QOL-ACD), adopted from Kurihara et al. (1999), was employed to assess the quality of life (QOL) among patients undergoing anticancer treatment. This questionnaire comprises 22 items distributed across five domains: six items for daily activities, five for physical condition, five for mental and psychological status, five for social activities, and one for general QOL (evaluated via a face scale). Each item was rated on a 5-point scale, with scores ranging from 1 (lowest QOL) to 5 (highest QOL), yielding a total score between 22 and 110; higher scores indicate better QOL.
Patients' responses were classified into three categories based on their scores: good (≤75%), average (50%-<75%), and low (>50%), according to the scoring framework by Saad and Elsayed (2021). Negative statements were reverse scored to align with the Likert scale format, ensuring consistency in the evaluation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa El Din Moustafa Hamed Abd Elaleem, Helwan University
- Investigators
- Alaa El Din M Abd Elaleem, PhD, Principal investigator, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702982
- Sponsor's protocol ID
- NURRSC23071035
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Support, Real Impact: the Effectiveness of Tele-nursing in Alleviating Chemotherapy Symptoms Among Cancer Patients; a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT06702982
- Acronym / sponsor ID
- NURRSC23071035
- Conditions
- Cancer, Chemotherapy Effect, Quality of Life (QOL)
- Keywords
- chemotherpay, tele-nursing, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 25 Nov 2024 (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.
This quasi-experimental study evaluated a tele-nursing educational program's impact on improving the quality of life and managing chemotherapy-related symptoms in 74 adult cancer patients at Mansoura University Hospital in Egypt. Delivered via Telegram, the program involved weekly educational sessions, aiming to enhance symptom management and quality of life.
Detailed description
The study aimed to assess the effectiveness of a tele-nursing educational program in managing chemotherapy-related and cancer-related symptoms and improving the quality of life among adult cancer patients. Conducted at the Oncology Center at Mansoura University Hospital in Egypt, the study recruited 74 participants who completed structured interviews detailing their demographics, medical history, symptom severity (using the MDASI-A tool), and quality of life (using the QOL-ACD tool). The intervention, delivered via a Telegram group, included weekly educational sessions focused on managing chemotherapy symptoms. The sessions featured educational content and feedback, with outcomes measured through changes in symptom severity and quality of life scores before and after the intervention. This approach highlighted the program's potential to enhance patients' overall well-being and symptom management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled participants | Experimental | Behavioral: tele-nursing educational programThe intervention administered in this study was a tele-nursing educational program aimed at improving cancer patients' management of chemotherapy-related symptoms and enhancing their quality of life. The program was delivered via a Telegram group, which provided a platform for regular interaction between the patients and nursing staff. The educational content was designed to address common chemotherapy-related symptoms, such as nausea, fatigue, pain, and loss of appetite, and to provide guidance on managing these symptoms effectively. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Diagnosed with cancer and receiving treatment at an outpatient chemotherapy center
Key exclusion criteria (2 listed)
- • Having active, serious physical disease
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 |
|---|---|---|
| tele-nursing educational programThe intervention administered in this study was a tele-nursing educational program aimed at improving cancer patients' management of chemotherapy-related symptoms and enhancing their quality of life. The program was delivered via a Telegram group, which provided a platform for regular interaction between the patients and nursing staff. The educational content was designed to address common chemotherapy-related symptoms, such as nausea, fatigue, pain, and loss of appetite, and to provide guidance on managing these symptoms effectively. | Behavioural | Enrolled participants |
Primary outcome
cancer-related and treatment-related symptoms
Time frame: 3 months
The M.D. Anderson Symptom Inventory Arabic Version (MDASI-A), adapted from Nejmi et al. (2010), was utilized to assess the severity of cancer-related and treatment-related symptoms in a manner accessible to Arabic-speaking patients. Designed in straightforward Arabic, the tool evaluates both the intensity of 13 core symptoms commonly experienced by cancer patients and their interference with daily functioning. This makes the MDASI-A comprehensive while remaining brief enough to avoid imposing a burden on respondents. The MDASI-A employs a 0-2 numerical scale (Never = 0, Sometimes = 1, Always = 2), ensuring its usability even among less-educated individuals. It is also adaptable for telephone, computer, and other electronic methods of administration. Scores were converted to percentages to classify symptom intensity into three categories: low (<50%), average (50% to <75%), and high (≥75%) based on the method proposed by Daisuke and Makoto (2022).
1 secondary outcome
Quality of life for Cancer Patients
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- 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.
Alaa El Din M Abd Elaleem, PhD principal investigator
Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tele-nursing educational program in people with Cancer and Chemotherapy Effect, run by Helwan 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 25 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cancer-related and treatment-related symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2024.