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CompletedNCT01661816KALICOUUpdated Mar 13, 2026

Breast Cancer and Quality of Life

An observational study in Breast Cancer, sponsored by Centre Oscar Lambret. Completed at 4 sites in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by Centre Oscar Lambret · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
171
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
  • everyday issues
  • couple
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 171 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Centre Oscar Lambret is the lead sponsor of 127 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no life partner
  • inclusion criteria failure
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
171 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Behavioralinterview

    psychological, emotional, family and social parameters

06

What researchers measure

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

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

07

Study locations

4 sites
  • François Baclesse Center
    Caen, France
  • Oscar Lambret Center
    Lille, 59 020, France
  • Gustave Roussy Institut
    Paris, 75 005, France
  • Hospital
    Valenciennes, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01661816
Lead sponsor
Centre Oscar Lambret
Responsible party
Sponsor
First posted
Aug 10, 2012
Start date
Apr 2007
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Mar 13, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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