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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Lung Cancer, Prostate Cancer, Bladder Cancer, Cervix Cancer, Cancer of Endometrium, Cancer of Skin, Non-Hodgkin Lymphoma, Colorectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome 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.

Outcome Time Frame:

Is measured at three (T3) and twelve (T4) months after first measurement

Safety Issue:

No

Principal Investigator

Lilian Lechner, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Netherlands Open University, Faculty of Psychology

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MB254

NCT ID:

NCT00859768

Start Date:

April 2008

Completion Date:

October 2010

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Prostate Cancer
  • Bladder Cancer
  • Cervix Cancer
  • Cancer of Endometrium
  • Cancer of Skin
  • Non-Hodgkin Lymphoma
  • Colorectal Cancer
  • Cancer
  • Urinary Bladder Neoplasms
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Skin Neoplasms
  • Uterine Cervical Neoplasms
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Prostatic Neoplasms

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