Phone coaching may ease fatigue after breast cancer
NCT ID NCT04304924
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a personalized telephone-based weight loss program could help reduce fatigue in overweight or obese breast cancer survivors. 220 participants who had finished active treatment for early-stage breast cancer were enrolled. The program provided motivational coaching on diet and exercise over one year, and fatigue was measured using a standard questionnaire.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- personalized telephone-based health education and weight loss coaching
- What this could lead to
- If successful, this could show that a simple phone coaching program helps reduce fatigue and improve quality of life for overweight breast cancer survivors.
- What could go wrong
- This is a completed study, but results may not apply to all breast cancer patients. The intervention relies on participant motivation, and fatigue is subjective, so benefits may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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220 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Gustave Roussy
Villejuif, Val de Marne, 94805, France
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