Pain Treatment in Oncology Population. PaiNEd Study.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer
- Head and Neck Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Experimental design with two intervention groups and a control group. Effectiveness study. Intervention group 1: multimodal rehabilitation program + PNE Intervention group 2: multimodal rehabilitation program + traditional biomedical information Control group: Patient waiting list.Masking: Double (Participant, Care Provider)Masking Description: Participants who meet the inclusion criteria will be randomized into each of the groups using a random number generation program (EPIDAT 4.2, junta de Galicia). The sequence will be placed in an opaque envelope closed by a member outside the investigation and will be opened once the baseline assessment is completed, so the assessment staff will be masked for the randomization of the participants, thus reducing the risk of bias during the evaluation. The blinding of evaluators will be guaranteed by the fact that some members of the group are specialized in the treatment of cancer patients and others in their evaluation.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
People who have suffered cancer often do not find an adequate therapeutic response for the sequelae derived from its treatments. The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer surviv...
People who have suffered cancer often do not find an adequate therapeutic response for the sequelae derived from its treatments. The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) examine the reliability of the PaiNEd system to treat real patients; 3) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information. In this regard, there is a shortage of proposals for certain subgroups of patients who demand special attention. This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain, in which 15 cancer survivors will be studied to verify the reliability of the proposal. Secondly, a randomized controlled experimental study will be carried out in which 84 cancer survivors will be recruited and randomly assigned to the three study groups: a) physical recovery program + access to the PaiNEd system; b) physical recovery program + traditional biomedical recommendations; c) control group. The evaluation will be carried out at baseline (at the beginning of the study), at 8 weeks (time of completion of the intervention) and at 6 months of follow-up of the patients.
Tracking Information
- NCT #
- NCT04877860
- Collaborators
- Not Provided
- Investigators
- Not Provided
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