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Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment


Inclusion Criteria:



- Non-metastatic breast cancer (in situ or invesive)

- End of active treatments (surgery, chemotherapy and radiotherapy)

- No recurrence nor palliative care

- Min. 18 years

- Able to speak French

- Willing to be randomized to study intervention group

- Accept to give their written informed consent

Exclusion Criteria:

- No cognitive dysfunction

- No severe or uncontrolled psychiatric illness

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Physical wellbeing: emotion regulation ability (heart rate, relaxation, quality of life,...)

Outcome Description:

Questionnaires: Quality of life questionnaires: "EORTC QLQ-C30" and "EORTC-BR23" Edmonton symptom evaluation scale Way of life questionnaire

Outcome Time Frame:

Change from baseline in heart rate and relaxation ability at 6 (T2) and 12 months (T3)

Safety Issue:

No

Principal Investigator

Darius Razavi, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Université Libre de Bruxelles, Institut Jules Bordet

Authority:

Belgium: Jules Bordet Institute

Study ID:

Groupe support 22-007

NCT ID:

NCT01797354

Start Date:

July 2011

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • patients at the end of treatment
  • Breast Neoplasms

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