Clinical trial · Interventional
Integral Strategy to Supportive Care in Breast Cancer Patients
Integral Strategy to Supportive Care in Breast Cancer Patients Through Occupational Therapy and a M-health System: a Randomized Controlled Trial.
NCT02817724CI-TRIAL-00030038unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine if it is better an integral strategy, with a m-health system, when used in addition to a supervised treatment, versus the use of the m-health system alone, to improve the immediate and long-term Quality of Life of breast cancer survivors.
Conditions
Conditions (1)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BENECA System | Device | — | UNRESOLVED |
| Supervised-occupational therapy program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- m-Health group
- description
- BENECA System: The m-health group will use the BENECA app for 8 weeks.
- interventionNames
- Device: BENECA System
- type
- EXPERIMENTAL
- label
- Integral Group
- description
- BENECA System and Supervised-occupational therapy program: The integral groups will use the BENECA app and they will receive a face-to-face occupational therapy rehabilitation program for 8 weeks.
- interventionNames
- Device: BENECA System
- Other: Supervised-occupational therapy program
Primary outcomes (1)
- measure
- Quality of life (QLQ)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of stage I, II or IIIA breast cancer. * Overweight or obese, according to the Spanish Society for the Study of Obesity. * Basic ability to use mobile apps or living with someone who has this ability. * Medical clearance of participants. * Completion of adjuvant therapy except for hormone therapy. * Some functional or Range of Motion (ROM) limitations measures by goniometry and the DASH Questionnaire. * Have signed informed consent. Exclusion Criteria: * History of cancer recurrence. * Chronic disease or orthopedic issues that would interfere with the ability to participate in the rehabilitation program. * Uncontrolled hypertension (diastolic pressure \> 95mm Hg).
References
Publications (2)
- DERIVEDLozano-Lozano M, Galiano-Castillo N, Martin-Martin L, Pace-Bedetti N, Fernandez-Lao C, Arroyo-Morales M, Cantarero-Villanueva I. Monitoring Energy Balance in Breast Cancer Survivors Using a Mobile App: Reliability Study. JMIR Mhealth Uhealth. 2018 Mar 27;6(3):e67. doi: 10.2196/mhealth.9669. PMID 29588273
- DERIVEDLozano-Lozano M, Martin-Martin L, Galiano-Castillo N, Alvarez-Salvago F, Cantarero-Villanueva I, Fernandez-Lao C, Sanchez-Salado C, Arroyo-Morales M. Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial. BMC Med Inform Decis Mak. 2016 Nov 25;16(1):150. doi: 10.1186/s12911-016-0394-0. PMID 27887610