CCRO044: Quality of Life Assessments Associated With a Physician Communication Intervention for Prostate Cancer Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/21/2018 |
| Start Date: | July 17, 2017 |
| End Date: | July 17, 2021 |
| Contact: | Kristy R Lundahl, MS |
| Email: | krlundahl@ucdavis.edu |
| Phone: | 720-270-9458 |
Pilot Study to Measure the Health-related Quality of Life Associated With a Physician Communication Intervention for Prostate Cancer Patients Undergoing Definitive or Post-operative Radiation Treatment.
A generic cancer health-related quality of life measure will be used to assess the impact of
the patient-specific radiation therapy plan review using the European Organisation for
Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30. Patient
psychosocial adjustment will be assessed by the Memorial Anxiety Scale for prostate cancer
and the EORTC QLQ-C30 subdomain. Physician communication will be assessed with the UC Davis
Physician Communication adapted from the Cologne Patient Questionnaire.
The study will characterize the above health-related quality of life (HRQL) scores (EORTC QLQ
C-30, the Memorial Anxiety Scale, and the UC Davis Physician Communication) prior to
initiation of radiation (baseline), during the first week of treatment, at the end of
radiation treatment (6-8 weeks following initiation of treatment), and 12 months after
treatment ends.
the patient-specific radiation therapy plan review using the European Organisation for
Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30. Patient
psychosocial adjustment will be assessed by the Memorial Anxiety Scale for prostate cancer
and the EORTC QLQ-C30 subdomain. Physician communication will be assessed with the UC Davis
Physician Communication adapted from the Cologne Patient Questionnaire.
The study will characterize the above health-related quality of life (HRQL) scores (EORTC QLQ
C-30, the Memorial Anxiety Scale, and the UC Davis Physician Communication) prior to
initiation of radiation (baseline), during the first week of treatment, at the end of
radiation treatment (6-8 weeks following initiation of treatment), and 12 months after
treatment ends.
The primary purpose of this pilot study is to assess the feasibility of administrating a
battery of HRQL measures after the planned intervention is administered. Because
distributional information on the proposed HRQL measure has not been previously collected in
prostate cancer patients, this pilot study will provide the necessary descriptive statistical
information for the planned endpoint measures (summary scores for the HRQL battery) to help
plan a randomized trial evaluating the efficacy of the patient-provider communication
intervention. Men who are receiving definitive or post-operative radiation therapy for
management of prostate cancer at the University of California (UC) Davis will be recruited.
The study will administer a validated quality of life instrument (EORTC QLQ-C30), a
previously validated psychosocial instrument (Memorial Anxiety Scale), and assessment of
physician-patient communication using a new UC Davis Physician Communication Assessment
adapted from the validated Cologne Patient Questionnaire. The study will administer these
questionnaires prior to initiation of radiation (baseline), during the first week of
treatment, at the end of radiation treatment (6-8 weeks following initiation of treatment),
and 12 months after treatment ends.
battery of HRQL measures after the planned intervention is administered. Because
distributional information on the proposed HRQL measure has not been previously collected in
prostate cancer patients, this pilot study will provide the necessary descriptive statistical
information for the planned endpoint measures (summary scores for the HRQL battery) to help
plan a randomized trial evaluating the efficacy of the patient-provider communication
intervention. Men who are receiving definitive or post-operative radiation therapy for
management of prostate cancer at the University of California (UC) Davis will be recruited.
The study will administer a validated quality of life instrument (EORTC QLQ-C30), a
previously validated psychosocial instrument (Memorial Anxiety Scale), and assessment of
physician-patient communication using a new UC Davis Physician Communication Assessment
adapted from the validated Cologne Patient Questionnaire. The study will administer these
questionnaires prior to initiation of radiation (baseline), during the first week of
treatment, at the end of radiation treatment (6-8 weeks following initiation of treatment),
and 12 months after treatment ends.
Inclusion Criteria:
1. Diagnosis of prostate adenocarcinoma over the age of 18 years
2. Low, intermediate or high risk as defined by D'Amico risk groups treated with dose
escalated conventional fractionated radiation therapy
3. Patient deemed clinically appropriate for definitive, adjuvant or salvage radiation.
4. Patient most provide study specific informed consent prior to study entry.
5. Androgen deprivation allowed
6. Pelvic lymph radiation therapy allowed for high risk disease
Exclusion Criteria:
1. Metastatic prostate cancer
2. Positive pelvic nodes
3. Patients treated with radiation for palliative intent
4. Prior radiation therapy to the pelvis
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