Lifestyle Behavioural Intervention on Breast Cancer Survivors for the Treatment of Overweight/Obesity.

NCT ID: NCT06577545

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-07-31

Brief Summary

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The goal of this clinical trial is to compare a behavioural lifestyle intervention program (BL) to usual care (UC) in breast cancer survivors. The main questions it aims to answer are:

1. If the participants of the BL group will lose more weight than the UC group.
2. If the participants of the BL group will have more lifestyle benefits than the UC group.

Volunteers will participate in a 24-week behavioural program. This program aims to improve their nutrition and physical activity in order to lose at least 10% of their initial body weight.

Detailed Description

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Eligible participants should be female breast cancer survivors between the ages of 18 and 65, with a BMI between 25 and 40 kg/m2, and no active cancer therapy or ongoing treatment, except for hormonal or immune therapy.

The usual care (UC) group will receive WCRF cancer prevention recommendations. The behavioural lifestyle intervention program (BL) group will participate in a 24-week intervention targeting diet and physical activity to lose weight.

The program will be considered successful if participants lose at least 10% of their initial body weight. A secondary goal is to improve their nutrition and physical activity levels. The third and last goal is to improve their overall quality of life and their anxiety levels.

The behavioral program includes in-person online meetings, group online sessions, and digital counseling material. Considering that participants will be residing all around Greece, an internet videoconferencing technology will be required.

A qualitative study incorporating focus groups undertaken prior to this study to establish the methodology resulted in the utilization of synchronous and asynchronous media, as well as a combination of in-person and group sessions.

Conditions

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Breast Cancer Female Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Usual Care (UC)

Participants in Usual Care (UC) study arm will receive WCRF cancer prevention recommendations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Behavioural Lifestyle (BL)

24-week behavioural lifestyle intervention program.

Group Type ACTIVE_COMPARATOR

Behavioural Lifestyle (BL)

Intervention Type BEHAVIORAL

24-week behavioural lifestyle intervention

Interventions

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Behavioural Lifestyle (BL)

24-week behavioural lifestyle intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI between 25 and 40 kg/m2

Exclusion Criteria

* active cancer or any ongoing treatment except hormonal or immune therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Odysseas Androutsos

Professor of Nutrition and Clinical Dietetics, Department of Nutrition and Dietetics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Odysseas Androutsos, Professor

Role: STUDY_CHAIR

University of Thessaly

Locations

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University of Thessaly

Trikala, Thessaly, Greece

Site Status

Countries

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Greece

Central Contacts

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Odysseas Androutsos, Professor

Role: CONTACT

+30 24310 47108

Maria Perperidi, PhDc

Role: CONTACT

+306947272639

Facility Contacts

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Odysseas Androutsos, Professor

Role: primary

+30 24310 47108

Maria Perperidi, PhDc

Role: backup

+306947272639

References

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Perperidi M, Saliari D, Christakis C, Huybrechts I, Saloustros E, Theodorakis Y, Androutsos O. Identifying the effective behaviour change techniques in nutrition and physical activity interventions for the treatment of overweight/obesity in post-treatment breast cancer survivors: a systematic review. Cancer Causes Control. 2023 Aug;34(8):683-703. doi: 10.1007/s10552-023-01707-w. Epub 2023 May 6.

Reference Type BACKGROUND
PMID: 37149509 (View on PubMed)

Perperidi M, Saltaouras G, Konstandis A, De Craemer M, Saloustros E, Theodorakis Y, Androutsos O. Barriers and facilitators of healthy lifestyle and perspectives towards the development of weight loss programmes. Focus groups with post-treatment breast cancer survivors in Greece. J Nutr Sci. 2023 Nov 3;12:e111. doi: 10.1017/jns.2023.94. eCollection 2023.

Reference Type BACKGROUND
PMID: 37964978 (View on PubMed)

Saltaouras G, Perperidi M, Vantzou D, Vatsina K, Saloustros E, Theodorakis Y, Androutsos O. Determinants of lifestyle and body weight status among breast cancer survivors with overweight/obesity and perspectives towards the development of weight loss interventions: a qualitative study with health professionals from Greece. J Nutr Sci. 2024 Jan 23;13:e4. doi: 10.1017/jns.2023.117. eCollection 2024.

Reference Type BACKGROUND
PMID: 38282654 (View on PubMed)

Other Identifiers

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Behavioral Intervention in BCS

Identifier Type: -

Identifier Source: org_study_id

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