The Effectiveness of the Screening Inventory of Psychosocial Problems (SIPP) in Cancer Patients
2 other identifiers
interventional
568
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 10, 2009
CompletedFirst Posted
Study publicly available on registry
March 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedMarch 8, 2011
March 1, 2009
2.5 years
March 10, 2009
March 7, 2011
Conditions
Keywords
Outcome Measures
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.
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.
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.
Study Arms (4)
Intervention group 1
EXPERIMENTALPre-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.
Intervention group 2
EXPERIMENTALNo 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.
Control group 1
NO INTERVENTIONPre-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.
Control group 2
NO INTERVENTIONNo 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
- years of age or older
You may not qualify if:
- Metastases
- Less than 10 fractions of radiotherapy treatment (RT)
- Unable to read, and speak Dutch
- Unable to complete questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Netherlands Open Universitylead
- Dutch Cancer Societycollaborator
- Maastricht University Medical Centercollaborator
- Institute Verbeetencollaborator
- Maastro Clinic, The Netherlandscollaborator
Study Sites (1)
Institute Verbeeten
Tilburg, North Brabant, 5042 SB, Netherlands
Related Publications (2)
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.
PMID: 22067707DERIVEDBraeken 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.
PMID: 19508716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 10, 2009
First Posted
March 11, 2009
Study Start
April 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
March 8, 2011
Record last verified: 2009-03