Clinical trial · Interventional
Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors
Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter randomized controlled study will appraise the effectiveness and cost-utility of an e-health ecosystem with integrated and stepped psychosocial services that will be compared with the usual psychosocial care. The study is developed in the acute survival phase among breast cancer survivors. The outcomes of both interventions will be compared in terms of the amount of waiting time to receive psychosocial care and changes in several psychosocial variables. Finally, a comparative economic analysis will be conducted in other relevant psychosocial and health parameters. The e-health platform is expected to outperform usual care in the aforementioned indicators, while reaching high acceptability and usability by survivors, and additionally reducing costs for health providers.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Emotional Disorder | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online integrated and stepped psychosocial care | Behavioral | — | UNRESOLVED |
| Usual psychosocial care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Online integrated and stepped psychosocial care
- description
- A group of breast cancer survivors will be randomly allocated (1:1 allocation) to the online integrated and stepped psychosocial care group
- interventionNames
- Behavioral: Online integrated and stepped psychosocial care
- type
- EXPERIMENTAL
- label
- Usual psychosocial care
- description
- A group of breast cancer survivors will be randomly allocated (1:1 allocation) to the usual psychosocial care group
- interventionNames
- Behavioral: Usual psychosocial care
Primary outcomes (5)
- measure
- Change in Emotional Distress (HADS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged between 18 and 70 years with BC, within 6 weeks after diagnosis. * Having online access and a user-level knowledge of Internet. * Understanding of Spanish language. Exclusion Criteria: * Major depressive episode. * Significant autolytic ideation. * Showing symptoms of psychosis or substance abuse. * Intellectual disability. * Having a mobile phone with an old release of Android operating system, which is not compatible with the platform.
References
Publications (1)
- DERIVEDOchoa-Arnedo C, Medina JC, Flix-Valle A, Anastasiadou D. E-health ecosystem with integrated and stepped psychosocial services for breast cancer survivors: study protocol of a multicentre randomised controlled trial. BMJ Open. 2021 Mar 8;11(3):e041548. doi: 10.1136/bmjopen-2020-041548. PMID 34006024