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

Breast Cancer Clinical Trial

Official title:

The Effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in Cancer Patients Treated With Radiotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859768
• Other study ID #: MB254
• Secondary ID: Dutch Cancer Soc
• Status: Completed
• Phase: N/A
• First received: March 10, 2009
• Last updated: March 7, 2011
• Start date: April 2008
• Est. completion date: October 2010

Study information

• Verified date: March 2009
• Source: Netherlands Open University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Cancer of Endometrium
• Cancer of Skin
• Cervix Cancer
• Colorectal Cancer
• Lung Cancer
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma
• Prostate Cancer
• Skin Neoplasms
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Institute Verbeeten	Tilburg	Brabant

Sponsors (5)

Lead Sponsor	Collaborator
Netherlands Open University	Dutch Cancer Society, Institute Verbeeten, Maastricht University Medical Center, Maastro Clinic, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Is measured at three (T3) and twelve (T4) months after first measurement	No
Secondary	The secondary outcome measurements are patients' satisfaction with the radiotherapist-patient communication, psychosocial distress and quality of life.		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.	No