Breast Cancer Clinical Trial
Official title:
The Effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in Cancer Patients Treated With Radiotherapy.
The purpose of this study is to evaluate the effectiveness and feasibility of the Screening Inventory of Psychosocial Problems (SIPP) in consultation settings with respect to early recognition and treatment of psychosocial distress, communication between patients and physicians, and psychological distress and quality of life in cancer patients treated with radiotherapy (RT).
Background: The Screening Inventory of Psychosocial Problems (SIPP) is a short, validated
self-administered questionnaire to identify psychosocial problems in cancer patients. The
one page 24-item questionnaire assesses physical complaints, psychological complaints, and
social and sexual problems. There is very little known about the effectiveness of using the
SIPP in consultation settings.
Aim: The aim of this study is to test the hypothesis that using the SIPP may prevent
underdiagnosis of early symptoms reflecting psychosocial problems, should facilitate
communication between physicians and patients about psychosocial distress and may contribute
to adequate referral to relevant psychosocial caregivers.
Methods: A Cluster Randomized Controlled Trail (CRCT) is developed using a Solomon
four-group design (two intervention and two control groups) to evaluate the effects of using
the SIPP. Radiotherapists instead of patients are at random allocated to experimental or
control groups. All included patients are randomized into the groups with and without
pre-measurement. Psychosocial distress, quality of life, patients' satisfaction about
communication with their radiotherapist during first consultation and the number and type of
referred patients to psychosocial caregivers are assessed. Self-administered assessments are
conducted at four times: pre-test before first consultation (T1), and post-tests directly
following the first consultation (T2), three months (T3) and one year after (T4) the first
measurement. Medical information are gathered from patients' medical records. Furthermore, a
process evaluation is carried out.
Relevance: Using the SIPP may lead to a reduction of psychosocial problems and better
quality of life, both on the short and long term. If the SIPP proves to be effective, the
results of this project may contribute to motivate health care workers to use the SIPP as a
standard method for early detection of psychosocial distress in oncology departments in the
Netherlands and abroad.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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