Trial · NCT07893327
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Health-Related Quality of Life | through study completion, an average of 1 year | Evaluate the effect of a regular physical exercise intervention compared with standard care on health-related quality of life in patients with breast cancer using EORTC QLQ-BR42 questionnaires. |
| Secondary | Change in physical activity level asseseed by IPAQ. | through study completion, an average of 1 year | Physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher levels of physical activity. |
| Secondary | Bioelectrical impedance analysis (BIA). | through study completion, an average of 1 year | Assess changes in nutritional status and body composition using bioelectrical impedance analysis (BIA). |
| Secondary | Change in Mediterranean Diet Adherence Screener (MEDAS) score | through study completion, an average of 1 year | Adherence to the Mediterranean dietary pattern will be evaluated using the MEDAS questionnaire. |
| Secondary | Change in dietary intake | through study completion, an average of 1 year | Assess dietary intake using a Food Frequency Questionnaire and a three-day dietary record. |
| Secondary | Change in sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI). | through study completion, an average of 1 year | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. |
| Secondary | Change in depressive symptoms assessed by Patient Health Questionnaire-9 (PHQ-9). | through study completion, an average of 1 year | Depressive symptom severity will be measured using the Patient Health Questionnaire-9. |
| Secondary | Change in anxiety symptoms assessed by IPIP-ANX. | through study completion, an average of 1 year | Anxiety symptoms will be assessed using the IPIP Anxiety scale. |
| Secondary | Change in perceived cognitive function assessed by FACT-Cog. | through study completion, an average of 1 year | Cognitive function will be assessed using the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) |
| Secondary | Genetic and epigenetic biomarkers measured by Illumina Infinium Methylation chips. | Baseline | Genetic and epigenetic biomarkers will be assessed at baseline through analysis of selected SNPs and DNA methylation profiles using commercially available panels related to cancer progression, lifestyle factors, metabolic regulation, hematopoietic alterations, and microbiota-associated pathways. |
| Secondary | Longitudinal Changes in Gut Microbiota Composition and Diversity Assessed by 16S rRNA Gene Sequencing | through study completion, an average of 1 year | Gut microbiota composition and microbial functional profiles will be characterized at baseline and throughout follow-up to assess changes associated with physical activity and lifestyle factors. |
| Secondary | Metabolomic and immunosenescence biomarker modulation | through study completion, an average of 1 year | Changes in metabolomic profiles and immunosenescence-associated molecular markers will be evaluated to characterize the biological effects of the intervention |
| Secondary | Progression-Free Survival (PFS) and Overall Survival (OS) | From date of randomization until the end of follow-up, assessed up to 52 weeks | PFS and OS by investigator assessment. |
| Secondary | Usability and Acceptability of the Digital Health Platform | Through study completion, an average of 1 year | Assess the usability, user experience, participant satisfaction, and adherence associated with the digital health platform implemented as a support tool for the study. |
| Secondary | Change in patient activation assessed by PAM-13. | Through study completion, an average of 1 year | Knowledge, skills, and confidence for self-management will be assessed, using the 13-item Patient Activation Measure (PAM-13). |
| Secondary | Longitudinal Changes in Clinical Laboratory Parameters Assessed by Routine Laboratory Tests | Through study completion, an average of 1 year | Assess changes over time in routine clinical laboratory parameters, including complete blood count, coagulation profile, blood biochemistry, lipid profile, and glycemic profile. |
| Secondary | Nutritional Biomarkers | Through study completion, an average of 1 year | Assess changes in nutritional biomarkers, including vitamins (A, B1, B6, B9, B12, C, D, and E), iron, ferritin, zinc, magnesium, selenium, sodium, potassium, chloride, calcium, phosphorus, copper, albumin, and prealbumin. |
| Secondary | Inflammatory Biomarkers | Through study completion, an average of 1 year | Assess changes in inflammatory biomarkers, including interleukin (IL)-1β, IL-6, IL-8, IL-10, tumor necrosis factor alpha (TNF-α), and C-reactive protein (CRP). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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