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

Centre Oscar Lambret

Status: Terminated

Conditions: Breast Cancer

Treatments: Behavioral: interviews with a psychologist; Behavioral: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT01780064

APAPI-1202

Details and patient eligibility

About

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

Full 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)

Enrollment: 128 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups, including a placebo group

Standard group

Placebo Comparator group

Description:

routine monitoring with questionnaires

Treatment:

Behavioral: Questionnaires

Interviews with psychologist

Active Comparator group

Description:

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

Treatment:

Behavioral: Questionnaires

Behavioral: interviews with a psychologist