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Psychosocial Support to Facilitate the Return to Employment of Women With Breast Cancer (APAPI)

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ClinicalTrials.gov Identifier: NCT01780064
Recruitment Status : Active, not recruiting
First Posted : January 30, 2013
Last Update Posted : July 29, 2016
Sponsor:
Collaborator:
University Hospital, Lille
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:
The purpose of this study is to compare the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: interviews with a psychologist Behavioral: Questionnaires Not Applicable

Detailed Description:

For the group "intervention", patients have four interviews with a psychologist (at cure one of chemotherapy treatment, at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy).

In the 2 arms, patients receive 4 sets of questionnaires (baseline, month 12, month 18 and month 24)


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Active Early Individualized Psychosocial Accompaniment to Facilitate the Return to Employment of Women With Breast Cancer
Study Start Date : February 2013
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Standard group
routine monitoring with questionnaires
Behavioral: Questionnaires
Questionnaires
Active Comparator: Interviews with psychologist
Patients have interviews with a psychologist (at cure one of chemotherapy treatment,at cure six of chemotherapy treatment, at last radiotherapy session, and three months after the end of radiotherapy) and questionnaires
Behavioral: interviews with a psychologist
interviews with a psychologist
Behavioral: Questionnaires
Questionnaires



Primary Outcome Measures :
  1. Comparison of the effect of early individualized psychosocial assets versus a standard support on social inequalities in the rate of return to work [ Time Frame: At 24 months ]

Secondary Outcome Measures :
  1. Comparison between the two modes of care, social inequalities and calculating the cost / benefit ratio of the two modes of care [ Time Frame: At 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women ≥ 18 with work at the time of diagnosis
  • Presenting a unilateral breast cancer exclusively local extension
  • Having received surgery
  • Reporting of adjuvant chemotherapy (+ / - trastuzumab)
  • Reporting to radiotherapy or not (If radiotherapy, it will be done on site investigator)
  • In work at the time of diagnosis (employees, traders and professionals)
  • Patient affiliated to a social security scheme
  • Consent signed by the patient before the implementation of any specific procedure to study

Exclusion Criteria:

  • Presence of in situ lesions, cancer recurrence, metastatic disease immediately, location bilateral
  • Inability physical, psychological, psychiatric or cognitive responses to the questionnaires and participate in interviews
  • Recognition previous ALD (due to another disease)
  • Patient under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780064


Locations
France
Centre Marie Curie
Arras, France, 62000
Centre Pierre Curie
Beuvry, France, 62880
Centre Léonard de Vinci
Dechy, France, 59187
Centre Oscar Lambret
Lille, France, 59020
Centre Hospitalier
Valenciennes, France, 59300
Nouvelle Clinique des Dentellières
Valenciennes, France, 59300
Hôpital Privé de Villeneuve d'Ascq
Villeneuve d'Ascq, France, 59657
Sponsors and Collaborators
Centre Oscar Lambret
University Hospital, Lille
Investigators
Study Director: Sophie FANTONI, MD, PhD CHRU / Université Lille 2
Study Director: Jacques BONNETERRE, MD, PhD Centre Oscar Lambret

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01780064     History of Changes
Other Study ID Numbers: APAPI-1202
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases