NCT02867475

Brief Summary

Study 1: The investigator hypothesizes that the level of knowledge about the benefits of physical activity, physical activity level and physical fatigue level observed in cancer patients, would influence their beliefs about physical activity and their intention to engage in AP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
Last Updated

September 30, 2025

Status Verified

August 1, 2016

Enrollment Period

2.2 years

First QC Date

August 11, 2016

Last Update Submit

September 29, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • CaBES

    psychometric measures: Cancer Beliefs and Exercise Scale Questionnaire

    1 day

Secondary Outcomes (2)

  • Multidimensional Fatigue Inventory

    1 day

  • Dijon's Score

    1 day

Study Arms (1)

A

OTHER

Physical activity motivation

Other: Physical activity motivation

Interventions

Physical activity motivationOTHER

Physical activity motivation

A

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PS 0-3
  • Patients with breast cancer undergoing chemotherapy treatment
  • neoadjuvant, adjuvant, metastatic, any histological type, any stage breast cancer
  • Sedentary Patients (physical activity score of Dijon less than or equal to 20)

You may not qualify if:

  • Patients with PS greater than 3
  • Patients with cognitive disorders not allowing them to understand the questionnaires and study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Antoine LACASSAGNE

Nice, 06189, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Véronique MARI, md

    Centre Antoine Lacassagne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

October 1, 2013

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

September 30, 2025

Record last verified: 2016-08

Locations

FR(1)