Clinical trial NCT00859768: The Effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in Cancer Patients
Official title: The Effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in Cancer Patients Treated With Radiotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Prostate Cancer
Bladder Cancer
Cervix Cancer
Cancer of Endometrium
Cancer of Skin
Non-Hodgkin Lymphoma
Colorectal Cancer
Keywords: Cancer
Lead sponsor: Netherlands Open University
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: Maastricht University Medical Center
name: Institute Verbeeten
name: Maastro Clinic, The Netherlands
First posted: 2009-03-11
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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 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

Primary outcomes:
measure: 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.
timeFrame: Is measured at three (T3) and twelve (T4) months after first measurement
Secondary outcomes:
measure: The secondary outcome measurements are patients' satisfaction with the radiotherapist-patient communication, psychosocial distress and quality of life.
timeFrame: 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.
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: Institute Verbeeten
state: Brabant
Study officials:
affiliation: Netherlands Open University, Faculty of Psychology
name: Lilian Lechner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University, Faculty of Health, Medicine, and life Sciences, Department of Health Care and Nursing Science, School for Public Health and Primary Care (CAPHRI)
name: Gertrudis I Kempen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braeken AP, Kempen GI, Eekers D, van Gils FC, Houben RM, Lechner L. The usefulness and feasibility of a screening instrument to identify psychosocial problems in patients receiving curative radiotherapy: a process evaluation. BMC Cancer. 2011 Nov 8;11:479. doi: 10.1186/1471-2407-11-479.
citation: Braeken AP, Lechner L, van Gils FC, Houben RM, Eekers D, Ambergen T, Kempen G. The effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in cancer patients treated with radiotherapy: design of a cluster randomised controlled trial. BMC Cancer. 2009 Jun 9;9:177. doi: 10.1186/1471-2407-9-177.