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

NCT03780023 | Completed

• 1 other identifier: 1072827
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Change in health-related quality of life

  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.

  Baseline, 6 to 8 weeks

• Change in psychosocial health

  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.

  Baseline, 6 to 8 weeks

• Change in physician-patient communication

  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."

  Baseline, 6 to 8 weeks

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This is a prostate cancer protocol.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Health

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Richard K Valicenti, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 19, 2018
• Study Start: July 17, 2017
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

US (1)