Bladder Cancer, Breast Cancer, Cancer of Endometrium, Cancer of Skin, Cervix Cancer, Colorectal Cancer, Lung Cancer, Non-Hodgkin Lymphoma, Prostate Cancer
Conditions
Keywords
Cancer
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.
Interventions
OTHERQuestionnaire administration
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.
Sponsors
Dutch Cancer Society
Maastricht University Medical Center
Institute Verbeeten
Maastro Clinic, The Netherlands
Netherlands Open University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
Netherlands
Outcome results
None listed