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

March 7, 2011 updated by: Netherlands Open University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

568

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Brabant
      • Tilburg, Brabant, Netherlands, 5042 SB
        • Institute Verbeeten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other Names:
  • Screening
  • Psychosocial assessment
Experimental: 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.
Other: 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.
Other Names:
  • Screening
  • Psychosocial assessment
No Intervention: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary effect outcome measurement is the number and type of referred patients with psychosocial problems to psychosocial caregivers and type of referrals with respect to psychosocial problems.
Time Frame: Is measured at three (T3) and twelve (T4) months after first measurement
Is measured at three (T3) and twelve (T4) months after first measurement

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary outcome measurements are patients' satisfaction with the radiotherapist-patient communication, psychosocial distress and quality of life.
Time Frame: Patients' satisfaction with the radiotherapist-patient communication is measured after first consultation with radiotherapist (T2) and psychosocial distress and quality of life is measured at three (T3) and twelve months (T4) after first measurement.
Patients' satisfaction with the radiotherapist-patient communication is measured after first consultation with radiotherapist (T2) and psychosocial distress and quality of life is measured at three (T3) and twelve months (T4) after first measurement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Netherlands Open University

Collaborators

Maastricht University Medical Center
Dutch Cancer Society
Maastro Clinic, The Netherlands
Institute Verbeeten

Investigators

  • Principal Investigator: Lilian Lechner, PhD, Netherlands Open University, Faculty of Psychology
  • Principal Investigator: Gertrudis I Kempen, PhD, Maastricht University, Faculty of Health, Medicine, and life Sciences, Department of Health Care and Nursing Science, School for Public Health and Primary Care (CAPHRI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Estimate)

March 8, 2011

Last Update Submitted That Met QC Criteria

March 7, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB254
  • Dutch Cancer Society (Registry Identifier: 2008-4008)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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