- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07457112
EHealth Educational Intervention to Improve Self-Management and Coping Behaviors Among Cancer Patients (EHCancer)
A Controlled Evaluation of EHealth Interventions for Self-Management and Psychological Coping in Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cancer patients often experience complex physical and psychological challenges related to disease progression and treatment side effects. eHealth interventions offer accessible, personalized, and cost-effective tools that support patient engagement, self-efficacy, and coping.
This study applies a structured eHealth intervention grounded in Self-Determination Theory to enhance autonomy, competence, and relatedness among cancer patients. The intervention includes synchronous online sessions, digital educational materials, and ongoing communication via mobile platforms over six weeks. Outcomes are measured using validated self-management and coping scales before and after the intervention. The study contributes evidence on the effectiveness of digital health interventions within the Saudi Arabian healthcare context.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zagazig, Egypt, 44519
- Faculty of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female adult cancer patients
- Diagnosed with cancer and currently receiving chemotherapy
- Able to read and understand Arabic
- Own a mobile phone and able to use online applications (e.g., Zoom or similar platforms)
- Willing to participate in the eHealth educational program
- Provided informed consent to participate in the study
Exclusion Criteria:
- Patients with severe cognitive impairment or psychiatric disorders that interfere with participation
- Patients with critical health conditions preventing attendance in the intervention sessions
- Patients who participated in similar structured educational or coping programs during the study period
- Patients unwilling to complete baseline or follow-up assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Structured eHealth Intervention Group
Participants receive a structured eHealth educational intervention program delivered over six weeks in addition to routine care.
The program focuses on enhancing self-management skills and psychological coping strategies among cancer patients.
|
The intervention consists of structured online educational sessions delivered via video conferencing platforms, supported by digital educational materials including videos and informational resources.
The program incorporates scenario-based discussions, peer interaction, and continuous follow-up communication.
The content focuses on symptom self-management, emotional regulation, and adaptive coping strategies for cancer patients.
|
|
No Intervention: Routine Care Control Group
Participants receive routine care provided by the healthcare facility without additional eHealth educational intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Symptom-Management Self-Efficacy Score
Time Frame: Baseline and 6 weeks (immediately post-intervention)
|
Measured using the Symptom-Management Self-Efficacy Scale (SMSE) developed by Liang et al. (2015).
The scale consists of 27 items across three subscales: acquiring problem-solving (7 items), managing chemotherapy-related symptoms (15 items), and managing emotional and interpersonal disturbance (5 items).
Each item is scored on an 11-point scale ranging from 0 (not at all confident) to 10 (completely confident).
The total possible score ranges from 0 to 270.
Higher scores indicate greater perceived self-efficacy in symptom management.
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Baseline and 6 weeks (immediately post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Coping Behavior Score
Time Frame: Baseline and 6 weeks (post-intervention)
|
Measured using the Jalowiec Coping Scale developed by Jalowiec and Powers (1981).
The scale includes 40 items divided into two subscales: affective-oriented coping (25 items) and problem-oriented coping (15 items).
Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (always).
The total possible score ranges from 0 to 160.
Higher scores indicate greater use of coping strategies.
|
Baseline and 6 weeks (post-intervention)
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Correlation Between Self-Efficacy and Coping Scores
Time Frame: 6 weeks (post-intervention)
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Assessment of the correlation between total Symptom-Management Self-Efficacy Scale scores and total Jalowiec Coping Scale scores at post-intervention.
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6 weeks (post-intervention)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Neoplasms by Site
- Intestinal Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Hematologic Diseases
- Colonic Diseases
- Skin Diseases
- Breast Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Skin and Connective Tissue Diseases
- Hemic and Lymphatic Diseases
- Neoplasms
- Colonic Neoplasms
- Breast Neoplasms
- Lymphoma
- Multiple Myeloma
Other Study ID Numbers
- SU-ERC-2023-011-EH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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