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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304924
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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))

Condition or disease Intervention/treatment Phase
Overweight or Obese Breast Cancer Patients Other: The personalized telephone based intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Motivating to Exercise and Diet, and Educating to Healthy Behaviors After Breast Cancer
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Personalised telephone-based health education

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

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.

No Intervention: Standard health educational program



Primary Outcome Measures :
  1. Fatigue [ Time Frame: up to 12 months ]
    will be assessed using the EORTC QLQ-C30 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304924


Contacts
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Contact: Ines VAZ LUIS, MD 0142114211 ext +33 INES-MARIA.VAZ-DUARTE-LUIS@gustaveroussy.fr
Contact: Stefan MICHIELS, MD 0142114211 ext +33 Stefan.michiels@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94805
Contact: Ines VAZ LUIS, MD    0142114211 ext +33    INES-MARIA.VAZ-DUARTE-LUIS@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT04304924    
Other Study ID Numbers: 2019-A02374-53
2019/2986 ( Other Identifier: CSET number )
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Overweight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight