Evaluation of an e-health intervention for cancer patients support

Evaluation of an e-health intervention for cancer patients support: a randomised pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN00735390

Enrollment

Registered

2011-11-14

Start date

2011-12-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast and colorectal cancer Cancer Malignant neoplasm of breast

Interventions

Intervention group: Patients will complete a Web-based chemotherapy-associated toxicity questionnaire twice a day. The questionnaire is based on the Common Terminology Criteria for Adverse Events (CTC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Feasibility and safety of a new e-health system (Oncomed) for the support of cancer patients during chemotherapy treatment	—

Secondary

Measure	Time frame
1. Effect of Oncomed on chemotherapy-associated toxicity control: 1.1. Number of toxicity-associated interventions 1.2. Toxicity evolution in each patient 1.3. Number of treatment withdrawals due to elevate toxicity 2. Quality of life (EORTC QLQ-C30 questionnaire at baseline and after 3 and 6 chemotherapy cycles) 3. Impact of Oncomed on health service use: 3.1. Number and duration of hospital admissions 3.2. Number of emergency department visits 3.3. Number of specialist care visits 3.4. Number of Outpatient Chemotherapy Unit visits 3.5. Number of primary care visits 3.6. Number of telephone calls 4. Cost analysis 5. Patient and professional satisfaction with the tele-oncology system through qualitative analysis (in-depth interviews and discussion groups)	—

Measure

Time frame

1. Effect of Oncomed on chemotherapy-associated toxicity control: 1.1. Number of toxicity-associated interventions 1.2. Toxicity evolution in each patient 1.3. Number of treatment withdrawals due to elevate toxicity 2. Quality of life (EORTC QLQ-C30 questionnaire at baseline and after 3 and 6 chemotherapy cycles) 3. Impact of Oncomed on health service use: 3.1. Number and duration of hospital admissions 3.2. Number of emergency department visits 3.3. Number of specialist care visits 3.4. Number of Outpatient Chemotherapy Unit visits 3.5. Number of primary care visits 3.6. Number of telephone calls 4. Cost analysis 5. Patient and professional satisfaction with the tele-oncology system through qualitative analysis (in-depth interviews and discussion groups)

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026