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| ID | Type | Description | Link |
|---|---|---|---|
| 0261_B | Other Identifier | Hospital Beatriz Ângelo |
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Intervention programs in cancer patients have been proposed with the aim of improving outcome. Bearing in mind that compliance is a limiting factor to the benefit provided from exercise and diet, assessing adherence to these interventions is paramount before pursuing further studies. Therefore the purpose of this study was to study the adherence of gastrointestinal cancer patients to a Combined Exercise and Dietary Intervention (CEDI) during neo-adjuvant chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Exercise and Dietary Intervention | Experimental | Behavioral Intervention |
|
| Control | Other | Standard Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Exercise and Dietary Intervention (CEDI) | Behavioral | Intervention aimed at conveying a supervised combined moderate aerobic and resistance training, once a week with a duration of 40-60 minutes plus daily home exercise, personalized according to patients' age and functional status. Dietary intervention aimed at a one-on-one nutritional counseling. In the first visit a dietary plan is designed and one daily oral nutritional supplement (Forticare®, Nutricia) is given to meet the European Society of Parenteral and Enteral Nutrition (ESPEN) recommended intake. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that adhere to a Combined Exercise and Dietary Intervention (CEDI) | The aim of this study was to assess intervention adherence defined as the number of participants willing to engage in CEDI. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that meet estimated dietary intake and exercise goals | We will assess the number of participants able to achieve their estimated dietary goals, namely 25-30kcal/day and 1-1.5g protein day and at least attending to 50% of planed exercise sessions. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Cravo | Hospital da Luz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Beatriz Ângelo | Loures | Lisbon District | 2674-514 | Portugal |
Study protocol with statistical analysis plan will be uploaded to trials.gov.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2018 | Jan 31, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D002100 | Cachexia |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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|
| Standard Care | Behavioral | Standard Care |
|
| D005767 |
| Gastrointestinal Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006298 |
| Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |