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

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))

Study Overview

• Status: Unknown
• Conditions: Overweight or Obese Breast Cancer Patients
• Intervention / Treatment: Other: The personalized telephone based intervention

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan MICHIELS, MD; Phone Number: +33 0142114211; Email: Stefan.michiels@gustaveroussy.fr
• Study Contact Backup: Name: Ines VAZ LUIS, MD; Phone Number: +33 0142114211; Email: INES-MARIA.VAZ-DUARTE-LUIS@gustaveroussy.fr

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94805
      • Recruiting
      • Gustave Roussy
      • Contact: Ines VAZ LUIS, MD; Phone Number: +33 0142114211; Email: INES-MARIA.VAZ-DUARTE-LUIS@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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:

  1. Subjects must have histologically confirmed invasive BC and registration must occur within 12 months after the end of active treatment,
  2. Bilateral breast carcinoma is allowed,
  3. Patients must have Stage I toIII BC and no evidence of distant metastatic or locally recurrent disease,
  4. 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 :

  1. 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,
  2. Patients may have breast reconstruction during protocol participation, but definitive BC surgery must be completed at least 21 days prior to registration,
  3. Biologic therapy, hormonal therapy, and bisphosphonates are acceptable.

• Other:

  1. Age ≥ 18 years,
  2. ECOG Performance Status 0 or 1,
  3. Self-reported ability to walk at least 400 metres (at any pace),
  4. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol,
  5. Patients must be affiliated to a social security system or beneficiary of the same.

Exclusion Criteria:

1. 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,
2. 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,
3. 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,
4. Secondary overweight or obesity documented or suspected,
5. Chronic consumption of corticosteroids,
6. Self reported pregnancy or intent to become pregnant in the year after enrollement,
7. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalised telephone-based health education; The personalized telephone based intervention: 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);; 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; The personalized telephone based intervention: 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);; 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.
No Intervention: Standard health educational program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	will be assessed using the EORTC QLQ-C30 questionnaire	up to 12 months

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Body Weight; Breast Neoplasms; Overweight
• Other Study ID Numbers: 2019-A02374-53; 2019/2986 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No