Evaluation of an e-health intervention for cancer patients support
- Conditions
- Breast and colorectal cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN00735390
- Lead Sponsor
- Quality Agency for the Spanish Health System (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Patients with breast or colorectal cancer of any gender
2. Starting a new chemotherapy regime with Capecitabine or CAPOX (Capecitabine plus Oxaliplatin)
3. Willing to use tele-health technologies
4. Capable of communicating and reading in Spanish
1. Paediatric patients (younger than14 years of age)
2. Refusal to participate in the study
3. Patients taking part in another clinical trial
4. Those unable to use Information and Communication Technologies (ICTs)
5. Cognitive impairment
6. Physical disabilities preventing participants from using the e-health system
7. Patients with other tumour locations in addition to those specified under the inclusion criteria
8. Patients undergoing radiotherapy treatment
9. Those with life expectancy less than 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility and safety of a new e-health system (Oncomed) for the support of cancer patients during chemotherapy treatment
- Secondary Outcome Measures
Name Time Method 1. Effect of Oncomed on chemotherapy-associated toxicity control: <br>1.1. Number of toxicity-associated interventions<br>1.2. Toxicity evolution in each patient<br>1.3. Number of treatment withdrawals due to elevate toxicity<br>2. Quality of life (EORTC QLQ-C30 questionnaire at baseline and after 3 and 6 chemotherapy cycles)<br>3. Impact of Oncomed on health service use:<br>3.1. Number and duration of hospital admissions<br>3.2. Number of emergency department visits<br>3.3. Number of specialist care visits<br>3.4. Number of Outpatient Chemotherapy Unit visits<br>3.5. Number of primary care visits<br>3.6. Number of telephone calls<br>4. Cost analysis<br>5. Patient and professional satisfaction with the tele-oncology system through qualitative analysis (in-depth interviews and discussion groups)