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

This study has been completed.
Sponsor:
Collaborators:
Dutch Cancer Society
Maastricht University Medical Center
Institute Verbeeten
Maastro Clinic, The Netherlands
Information provided by:
Netherlands Open University
ClinicalTrials.gov Identifier:
NCT00859768
First received: March 10, 2009
Last updated: March 7, 2011
Last verified: March 2009
  Purpose

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).


Condition Intervention
Breast Cancer
Lung Cancer
Prostate Cancer
Bladder Cancer
Cervix Cancer
Cancer of Endometrium
Cancer of Skin
Non-Hodgkin Lymphoma
Colorectal Cancer
Other: Questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in Cancer Patients Treated With Radiotherapy.

Resource links provided by NLM:


Further study details as provided by Netherlands Open University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 568
Study Start Date: April 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Psychosocial assessment
  • Screening
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:
  • Psychosocial assessment
  • Screening
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859768

Locations
Netherlands
Institute Verbeeten
Tilburg, Brabant, Netherlands, 5042 SB
Sponsors and Collaborators
Netherlands Open University
Dutch Cancer Society
Maastricht University Medical Center
Institute Verbeeten
Maastro Clinic, The Netherlands
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)
  More Information

No publications provided by Netherlands Open University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lilian Lechner, PhD, Netherlands Open University
ClinicalTrials.gov Identifier: NCT00859768     History of Changes
Other Study ID Numbers: MB254, Dutch Cancer Society
Study First Received: March 10, 2009
Last Updated: March 7, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Netherlands Open University:
Cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Breast Neoplasms
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Skin Neoplasms
Uterine Cervical Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Lymphoma
Lymphoma, Non-Hodgkin
Prostatic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Uterine Cervical Diseases
Intestinal Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014