Clinical trial NCT03780023: CCRO044: Quality of Life Assessments Associated With a Physician Communication Intervention for Prostate Cancer Patients
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Adenocarcinoma
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men age 18 and over with a diagnosis of prostate adenocarcinoma that is not characterized by metastatic cancer or positive pelvic nodes.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in health-related quality of life
timeFrame: Baseline, 6 to 8 weeks
measure: Change in psychosocial health
timeFrame: Baseline, 6 to 8 weeks
measure: Change in physician-patient communication
timeFrame: Baseline, 6 to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Health
state: California
Study officials:
affiliation: University of California, Davis
name: Richard K Valicenti, MD
role: PRINCIPAL_INVESTIGATOR
References: