The Effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-10-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Breast Cancer Lung Cancer Prostate Cancer Bladder Cancer Cervix Cancer Cancer of Endometrium Cancer of Skin Non-Hodgkin Lymphoma Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group 1

Pre-test measures are assessed. The patient receives the SIPP twice during their RT period. The first time is before the first consultation with the radiotherapist and the second time is before the last consultation at the end of the RT period. At both time points, the SIPP is handed over to the radiotherapist at the start of the consultation. The radiotherapist screens the scores of the SIPP to get an overview of potential psychosocial problems and patient's needs of psychosocial care. Follow-up measures are directly after first consultation (T2) and at three (T3) and twelve months (T4) after first measurement.

Group Type EXPERIMENTAL

Questionnaire administration

Intervention Type OTHER

The patient receives the SIPP at two different time points during their RT period. The first time point is before the first consultation with the radiotherapist (before starting RT) and the second time point is before the last consultation with the radiotherapist at the end of the RT period. At both time points, the SIPP is handed over to the radiotherapist at the start of the consultation. The radiotherapist screens the scores of the SIPP to get an overview of potential psychosocial problems and patient's needs of psychosocial care.

Intervention group 2

No pre-test measures are assessed. The patient receives the SIPP twice during their RT period. The first time is before the first consultation with the radiotherapist and the second time is before the last consultation at the end of the RT period. At both time points, the SIPP is handed over to the radiotherapist at the start of the consultation. The radiotherapist screens the scores of the SIPP to get an overview of potential psychosocial problems and patient's needs of psychosocial care. Follow-up measures are directly after first consultation (T2) and at three (T3) and twelve months (T4) after first measurement.

Group Type EXPERIMENTAL

Questionnaire administration

Intervention Type OTHER

The patient receives the SIPP at two different time points during their RT period. The first time point is before the first consultation with the radiotherapist (before starting RT) and the second time point is before the last consultation with the radiotherapist at the end of the RT period. At both time points, the SIPP is handed over to the radiotherapist at the start of the consultation. The radiotherapist screens the scores of the SIPP to get an overview of potential psychosocial problems and patient's needs of psychosocial care.

Control group 1

Pre-test measures are assessed. Enhanced usual care. Follow-up measures are directly after first consultation (T2) and at three (T3) and twelve months (T4) after first measurement.

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group 2

No pre-test measures are assessed. Enhanced usual care. Follow-up measures are directly after first consultation (T2) and at three (T3) and twelve months (T4) after first measurement.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Questionnaire administration

The patient receives the SIPP at two different time points during their RT period. The first time point is before the first consultation with the radiotherapist (before starting RT) and the second time point is before the last consultation with the radiotherapist at the end of the RT period. At both time points, the SIPP is handed over to the radiotherapist at the start of the consultation. The radiotherapist screens the scores of the SIPP to get an overview of potential psychosocial problems and patient's needs of psychosocial care.

Intervention Type OTHER

Other Intervention Names

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Psychosocial assessment Screening

Eligibility Criteria

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Inclusion Criteria

* Breast Cancer
* Lung Cancer
* Prostate cancer
* Bladder Cancer
* Colorectal Cancer
* Cervix Cancer
* Cancer of endometrium
* Cancer of Skin
* Hodgkin Lymphoma
* Non-Hodgkin Lymphoma
* Must receive radiotherapy treatment (RT)
* 18 years of age or older

Exclusion Criteria

* Metastases
* Less than 10 fractions of radiotherapy treatment (RT)
* Unable to read, and speak Dutch
* Unable to complete questionnaires

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Netherlands Open University

Principal Investigators

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Lilian Lechner, PhD

Role: PRINCIPAL_INVESTIGATOR

Netherlands Open University, Faculty of Psychology

Gertrudis I Kempen, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University, Faculty of Health, Medicine, and life Sciences, Department of Health Care and Nursing Science, School for Public Health and Primary Care (CAPHRI)