Lifestyle Behavioural Intervention on Breast Cancer Survi... | NCT06577545

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

NCT06577545

Sponsor

University of Thessaly

Status

Not yet recruiting

Last Update Posted

Aug 29, 2024Actual

Enrollment

92Estimated

Phase

Not Applicable

Conditions

Breast Cancer Female
Overweight and Obesity

Interventions

Behavioural Lifestyle (BL)

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2026Estimated

Primary Completion Date

Jun 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Aug 27, 2024

First Submission Date that Met QC Criteria

Aug 27, 2024

First Posted Date

Aug 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2024

Last Update Posted Date

Aug 29, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Odysseas Androutsos, Professor of Nutrition and Clinical Dietetics, Department of Nutrition and Dietetics, University of ThessalyPrincipal Investigator

Lead Sponsor

University of ThessalyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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:

If the participants of the BL group will lose more weight than the UC group.
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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Care (UC)	No Intervention	Participants in Usual Care (UC) study arm will receive WCRF cancer prevention recommendations.
Behavioural Lifestyle (BL)	Active Comparator	24-week behavioural lifestyle intervention program.	Behavioral: Behavioural Lifestyle (BL)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Behavioural Lifestyle (BL)	Behavioral	24-week behavioural lifestyle intervention	Behavioural Lifestyle (BL)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
body weight change	% of the initial body weight change	From enrollment to the end of treatment at 24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI between 25 and 40 kg/m2

Exclusion Criteria:

active cancer or any ongoing treatment except hormonal or immune therapy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

This study includes only biological female participants

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Odysseas Androutsos, Professor	Contact	+30 24310 47108		oandroutsos@uth.gr
Maria Perperidi, PhDc	Contact	+306947272639		mperperidi@uth.gr

Overall Officials

Name	Affiliation	Role
Odysseas Androutsos, Professor	University of Thessaly	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Thessaly		Trikala	Thessaly	42132	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37149509	Background	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.
37964978

ID	Term
D050177	Overweight
D009765	Obesity
D009043	Motor Activity

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight