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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780023
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.


Condition or disease Intervention/treatment
Prostate Adenocarcinoma Other: Questionnaire

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.

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
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.
Actual Study Start Date : July 17, 2017
Actual Primary Completion Date : May 4, 2020
Actual Study Completion Date : May 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • Other: 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.


Primary Outcome Measures :
  1. Change in health-related quality of life [ Time Frame: Baseline, 6 to 8 weeks ]
    The mean change in scores on the EORTC QLQ-C30 scale from pre-treatment to post-treatment. This scale has functional, global health, and symptoms subscales/items all scored from 0 to 100. Higher scores on these subscales indicate high level of functioning, high quality of life, and high level of symptomatology, respectively.

  2. Change in psychosocial health [ Time Frame: Baseline, 6 to 8 weeks ]
    The mean change in scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.

  3. Change in physician-patient communication [ Time Frame: Baseline, 6 to 8 weeks ]
    The mean change in scores on the UC Davis Physician Communication Assessment from pre-treatment to post-treatment. This scale was adapted from the validated Cologne Patient Questionnaire, which has subscales measuring devotion, support, information, and shared decision-making. Participants indicate their level of agreement with each item, from "totally disagree" to "totally agree."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This is a prostate cancer protocol.
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780023


Locations
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United States, California
University of California Davis Health
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Richard K Valicenti, MD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03780023    
Other Study ID Numbers: 1072827
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No