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NCT Number: NCT00859768

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

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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Key information

Conditions

Breast Cancer Bladder Cancer Breast Diseases Breast Neoplasms Cancer of Endometrium Cancer of Skin Cervix Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Non-Hodgkin Lymphoma Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute Verbeeten

Tilburg, North Brabant, 5042 SB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

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.

Other names: Psychosocial assessment, Screening

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Netherlands Open University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 11, 2009
Registry last updated
Mar 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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