Adherence to Exercise and Dietary Intervention in Cancer Patients

Not Applicable

Completed

• Conditions: Adherence; Gastrointestinal Cancer
• Interventions: Behavioral: Combined Exercise and Dietary Intervention (CEDI); Behavioral: Standard Care

• Registration Number: NCT05237921
• Lead Sponsor: Hospital Beatriz Ângelo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-15
• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-14
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with esophageal, gastric, pancreatic and rectal cancer
• Due to commence neo-adjuvant chemo/ radiotherapy (ChT)

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined Exercise and Dietary Intervention	Combined Exercise and Dietary Intervention (CEDI)	Behavioral Intervention
Control	Standard Care	Standard Care

Primary Outcome Measures

Name	Time	Method
Number of participants that adhere to a Combined Exercise and Dietary Intervention (CEDI)	8 weeks	The aim of this study was to assess intervention adherence defined as the number of participants willing to engage in CEDI.

Secondary Outcome Measures

Name	Time	Method
Number of participants that meet estimated dietary intake and exercise goals	8 weeks	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.

Trial Locations

Locations (1)

Hospital Beatriz Ângelo; 🇵🇹 Loures, Lisboa, Portugal