Motivating to Exercise and Diet, and Educating to Healthy Behaviors After Breast Cancer

NCT04304924 | Completed

• 2 other identifiers: 2019-A02374-532019/2986
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of MEDEA is to compare the effect of a personalised telephone-based health education weight loss program based on motivational coaching, exercise and diet versus a standard health educational program control on fatigue of overweight or obese BC patients (as measured by the EORTC QLQ C30 (Aaronson et al. 1993; Sprangers et al. 1996))

Conditions

Overweight or Obese Breast Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Fatigue

  will be assessed using the EORTC QLQ-C30 questionnaire

  up to 12 months

Study Arms (2)

Personalised telephone-based health education

EXPERIMENTAL

The personalized telephone based intervention: 1. Provide Behavioral support to facilitate lifestyle change by a weight loss coach located at a centralized call center. Participants will be paired with an individual coach who will work with the participant through all phases of the 1-year weight loss program. The behavior change program will be based on Social Cognitive Theory, which hypothesizes that the interactions between environmental, personal and behavioral elements determine behavioral change (Bandura 1989); 2. Utilize a toolbox approach that will allow for tailoring the intervention to the individual participant. Examples of possible Toolbox solutions include: alternative dietary approaches, instructions for strength-training exercises.

Other: The personalized telephone based intervention

Standard health educational program

NO INTERVENTION

Interventions

The personalized telephone based intervention OTHER

The personalized telephone based intervention: 1. Provide Behavioral support to facilitate lifestyle change by a weight loss coach located at a centralized call center. Participants will be paired with an individual coach who will work with the participant through all phases of the 1-year weight loss program. The behavior change program will be based on Social Cognitive Theory, which hypothesizes that the interactions between environmental, personal and behavioral elements determine behavioral change (Bandura 1989); 2. Utilize a toolbox approach that will allow for tailoring the intervention to the individual participant. Examples of possible Toolbox solutions include: alternative dietary approaches, instructions for strength-training exercises.

Personalised telephone-based health education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• This study will be focused on an overweight/obese (BMI ≥25 kg/m2) population of patients with early BC. Particularly, patients will be eligible if they have:
• Documentation of Disease:
• Subjects must have histologically confirmed invasive BC and registration must occur within 12 months after the end of active treatment,
• Bilateral breast carcinoma is allowed,
• Patients must have Stage I toIII BC and no evidence of distant metastatic or locally recurrent disease,
• No history of invasive BC in 5 years prior to study registration other than the current diagnosis (prior Ductal Carcinoma in situ (DCIS) at any time does not make a patient ineligible).
• Documentation of overweight/obesity: Subjects must have a BMI ≥25 kg/m2 objectively assessed at the time of eligibility evaluation or reported in the medical records within 56 days prior to study registration. The most recent BMI obtained must be used for eligibility. If most recent BMI is \<25 then the patient is not eligible to enroll.
• Prior Treatment :
• All adjuvant or neoadjuvant CT, radiation, and surgery completed at least 21 days prior to registration to a maximum of 365 days after the end of treatment,
• Patients may have breast reconstruction during protocol participation, but definitive BC surgery must be completed at least 21 days prior to registration,
• Biologic therapy, hormonal therapy, and bisphosphonates are acceptable.
• Other:
• Age ≥ 18 years,
• ECOG Performance Status 0 or 1,
• Self-reported ability to walk at least 400 metres (at any pace),

You may not qualify if:

• Participation in another clinical study with an investigational product that has Fatigue as a known frequent adverse effects during the last 3 months and while on study treatment,
• Participating in another weight loss, physical activity or dietary intervention clinical trial. Participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial,
• Comorbid conditions, such as other malignancy, diabetes, inflammatory bowel disease, history of severe cardiovascular, respiratory or musculoskeletal disease that would preclude adherence to the study diet or physical activity program or significantly affect the physical status, or the ability to give an informed consent,
• Secondary overweight or obesity documented or suspected,
• Chronic consumption of corticosteroids,
• Self reported pregnancy or intent to become pregnant in the year after enrollement,
• Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

Related Publications (1)

• Di Meglio A, Martin E, Crane TE, Charles C, Barbier A, Raynard B, Mangin A, Tredan O, Bouleuc C, Cottu PH, Vanlemmens L, Segura-Djezzar C, Lesur A, Pistilli B, Joly F, Ginsbourger T, Coquet B, Pauporte I, Jacob G, Sirven A, Bonastre J, Ligibel JA, Michiels S, Vaz-Luis I. A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design. Trials. 2022 Mar 4;23(1):193. doi: 10.1186/s13063-022-06090-6.

  PMID: 35246219 DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial that compares two weight loss programs (control health education program vs. personalized telephone-based health education program) for overweight patients with early breast cancer

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: June 17, 2020
• Primary Completion: June 21, 2023
• Study Completion: May 22, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

FR (1)