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Completed

NCT Number: NCT03780023

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

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.

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Key information

Conditions

Prostate Adenocarcinoma

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of California Davis Health

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of prostate adenocarcinoma over the age of 18 years
  • Low, intermediate or high risk as defined by D'Amico risk groups treated with dose escalated conventional fractionated radiation therapy
  • Patient deemed clinically appropriate for definitive, adjuvant or salvage radiation.
  • Patient most provide study specific informed consent prior to study entry.
  • Androgen deprivation allowed
  • Pelvic lymph radiation therapy allowed for high risk disease

Exclusion criteria

  • Metastatic prostate cancer
  • Positive pelvic nodes
  • Patients treated with radiation for palliative intent
  • Prior radiation therapy to the pelvis

Treatment and study plan

Questionnaire

Other

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 outcomes

  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."

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2018
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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