NCT01661816

Brief Summary

The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

4 active sites

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

April 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

August 2, 2012

Last Update Submit

March 12, 2026

Conditions

Keywords

breast cancereveryday issuescouple

Outcome Measures

Primary Outcomes (1)

  • quality of life at different time of medical follow up

    interviews with couples at different time frame depending on which group they are in

    6 months after diagnosis, 1 year after diagnosis, between 2 and 7 years after diagnosis, 7 years past diagnosis

Study Arms (5)

Within chemotherapy

30 couples, interviewed within chemotherapy (6 to 8 months after diagnosis)

Behavioral: interview

within Herceptin

30 couples, within herceptin treatment (the first year after diagnosis)

Behavioral: interview

within hormonotherapy

30 couples, within hormonotherapy (between 2 and 7 years after diagnosis)

Behavioral: interview

without hormonotherapy

30 couples, did not received hormonotherapy (1 year after diagnosis)

Behavioral: interview

end of treatment

30 couples, after end of treatments for patients who did received hormonotherapy (7 years after diagnosis)

Behavioral: interview

Interventions

interviewBEHAVIORAL

psychological, emotional, family and social parameters

Within chemotherapyend of treatmentwithin Herceptinwithin hormonotherapywithout hormonotherapy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patient with breast cancer, diagnosed before aged 45, having a life partner

You may qualify if:

  • age \< 45
  • non metastatic breast cancer
  • at least 6 months of relationship

You may not qualify if:

  • no life partner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

François Baclesse Center

Caen, France

Location

Oscar Lambret Center

Lille, 59 020, France

Location

Gustave Roussy Institut

Paris, 75 005, France

Location

Hospital

Valenciennes, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 10, 2012

Study Start

April 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations