CompletedNot Applicable

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

France220 participantsStarted 2020-06-17

Plain-language 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))

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. 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,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fatigue

Timeframe: up to 12 months

Trial details

NCT IDNCT04304924

SponsorGustave Roussy, Cancer Campus, Grand Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-21

View on ClinicalTrials.gov More Overweight or Obese Breast Cancer Patients trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. 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,

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria