Weight Management in Obese Cancer Patients During Curative Active Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut d'Investigació Biomèdica de Bellvitge
About this trial
This is a feasibility study intervention to fifty cancer patients with obesity and with newly diagnosed stage II-IV solid tumors undergoing curative treatment recruited at the Catalan Institute of Oncology (ICO) in L'Hospitalet, Spain.
The investigators hypothesize that weight management during cancer treatment could enhance health outcomes for this population. The feasibility of a multimodal weight loss management program will be assesses, including a personalized hypocaloric and high-protein diet combined with a supervised exercise home-program and behavioural support.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (age 18+) with pathologically confirmed malignant solid tumors, stage II-IV, elected for oncological treatment (chemo, radio, or both) with curative intend.
Expected oncological treatment time ≥ 3 months.
BMI ≥ 30 kg/m²
Resident in the Barcelona area up to the completion of cancer treatment.
Disqualifiers
Patients with melanoma and brain tumours.
Surgery as the only treatment.
Pregnancy or breastfeeding
Another active malignancy
Trial design
Design model
Single group
Treatments tested in this trial
Multimodal weight management program
BehavioralThis intervention consists of three components: * Nutritional Counseling: * A personalized hypocaloric and high-protein diet is prescribed, based on individual energy requirements with a 20% caloric reduction. * The protein intake target is 1.5 g/kg/day to promote fat loss while maintaining muscle mass. * Exercise Program * Home-based, supervised aerobic and resistance training sessions conducted 3 times per week. * Each 60-minute session includes: 5 minutes flexibility, 25 minutes aerobic training, 25 minutes resistance training, and 5 minutes balance exercises. * Behavioral Support * Patients receive training in problem-solving strategies, motivation, and emotional self-regulation to improve adherence to both dietary and exercise goals. * Health professionals delivering the intervention are trained in behavior change techniques by a clinical psychologist.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Cancer patients with obesity with active curative treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Accrual
Feasibility will be evaluated based on participant accrual, measured by the weekly enrollment rate and the total duration required to achieve the target sample size.
Time frame
From baseline to end of cancer treatment (3 to 9 months)2
Retention
Feasibility will be assessed based on participant retention, monitored through attendance records signed at each visit. Investigators will calculate the retention rate, dropout rate, time to dropout, and reasons for discontinuation.
Time frame
From baseline to end of cancer treatment (3 to 9 months)3
Fidelity of the programme delivery
Feasibility based on fidelity of the intervention will be assessed using a patient-completed checklist after each dietetic and physiotherapy session. Items will be scored as: +1: session content delivered as intended, 0: content omitted, -1: content delivered in a way that deviates from protocol. Fidelity scores will be aggregated, and if overall fidelity drops below 80%, retraining may be considered. Additionally, patients will complete a final evaluation form at the end of the program assessing intervention load, frequency, delivery format, behavioral support, and perceived value (e.g., effort, satisfaction, willingness to repeat).
Time frame
From baseline to end of cancer treatment (3 to 9 months)4
Nutritional adherence
Feasibility based on adherence will be evaluated using a 24-hour dietary recall to assess energy and protein intake. At the end of the intervention period, dietary adherence will also be defined as a 10-20% reduction in baseline calorie intake, along with maintenance or an increase in protein intake.
Time frame
From baseline to end of cancer treatment (3 to 9 months)Secondary outcomes
1
Change in Body Weight and Body Composition
Assessed by bioelectrical impedance analysis (BIA, InBody S10) at each dietetic visit. Measures include total weight change (kg), fat mass (kg), and preservation of muscle mass. In patients with available imaging, body composition will be analyzed using CT scan at the L3 vertebral level.
Time frame
Baseline to end of treatment (approx. 3 to 9 months)2
Change in Eating Self-Efficacy
Eating self-efficacy will be assessed using the scenario-based Dieting Self-Efficacy Scale (DIET-SE), consisting of 11 items evaluating confidence in managing challenges to dietary self-control. Responses to each item are assessed on a Likert-type rating scale ranging from 0 (not at all confident) to 4 (very con-fident).
Time frame
Baseline to the end of intervention (approx. 3 to 9 months)3
Change in physical activity self-efficacy
Exercise self-efficacy will be assessed using the modified Physical Activity Self-Efficacy Scale. A five-point Likert scale ranging from not at all confident (1) to very confident (5) will be used, higher scores indicating greater self-efficacy. Assessments will be conducted at baseline and at the end of the intervention.
Time frame
Baseline to the end of intervention (approx. 3 to 9 months)4
Change in Autonomous Motivation
Autonomous motivation will be assessed using an adapted and abbreviated version of the Treatment Self-Regulation Questionnaire (TSRQ). This scale includes four items rated on a 5-point Likert scale ranging from 1 ("not at all true") to 5 ("very true"). Higher scores indicate greater autonomous motivation toward behavior change. One-to-one psychological support may be offered to participants with low scores to enhance engagement.
Time frame
Baseline to the end of intervention (approx. 3 to 9 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut d'Investigació Biomèdica de Bellvitge
Lead sponsor
World Cancer Research Fund International
Collaborator
Institut Català d'Oncologia
Collaborator
Source ClinicalTrials.gov