search
Back to results

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

Primary Purpose

Breast Cancer, Lung Cancer, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Questionnaire administration
Sponsored by
Netherlands Open University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute Verbeeten

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Intervention group 1

Intervention group 2

Control group 1

Control group 2

Arm Description

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.

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.

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 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.

Outcomes

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.

Secondary Outcome Measures

The secondary outcome measurements are patients' satisfaction with the radiotherapist-patient communication, psychosocial distress and quality of life.

Full Information

First Posted
March 10, 2009
Last Updated
March 7, 2011
Sponsor
Netherlands Open University
Collaborators
Dutch Cancer Society, Maastricht University Medical Center, Institute Verbeeten, Maastro Clinic, The Netherlands
search

1. Study Identification

Unique Protocol Identification Number
NCT00859768
Brief Title
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

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Netherlands Open University
Collaborators
Dutch Cancer Society, Maastricht University Medical Center, Institute Verbeeten, Maastro Clinic, The Netherlands

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer, Prostate Cancer, Bladder Cancer, Cervix Cancer, Cancer of Endometrium, Cancer of Skin, Non-Hodgkin Lymphoma, Colorectal Cancer
Keywords
Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group 1
Arm Type
No Intervention
Arm Description
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.
Arm Title
Control group 2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaire administration
Other Intervention Name(s)
Psychosocial assessment, Screening
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilian Lechner, PhD
Organizational Affiliation
Netherlands Open University, Faculty of Psychology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gertrudis I Kempen, PhD
Organizational 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)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute Verbeeten
City
Tilburg
State/Province
Brabant
ZIP/Postal Code
5042 SB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22067707
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.
Results Reference
derived
PubMed Identifier
19508716
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs