CCRO044: Quality of Life Assessments Associated With a Physician Communication Intervention for Prostate Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-17

Study Completion Date

2020-05-04

Brief Summary

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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

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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.

Conditions

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Prostate Adenocarcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire

All patients will receive three questionnaires at four different time points during their radiation treatment. The time points are 1) before treatment, 2) during the first week of treatment, 3) at the end of treatment (6-8 weeks after treatment begins), and 4) one year after treatment ends.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard K Valicenti, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California Davis Health

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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1072827

Identifier Type: -

Identifier Source: org_study_id