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Behavioural Intervention
BC/WC Communication Tool for Cancer Decision Making in Older Adults
N/A
Recruiting
Led By Melisa L Wong, MD, MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with a solid tumor malignancy of any stage.
Age >= 65 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completed once at the end of study participation (approximately 18 months)
Awards & highlights
Study Summary
This trial will test a new communication tool for doctors to use with older adults who have advanced cancer. The goal is to see if it is feasible and accepted by both patients and doctors.
Who is the study for?
This trial is for older adults aged 65 or above with any stage of solid tumor cancer, who are about to make a treatment decision. They must be able to understand and consent to the study, have adequate mental capacity, and speak English. Oncologists participating need to treat at least 10 such patients annually and commit to the study's duration.Check my eligibility
What is being tested?
The trial tests a communication tool called BC/WC-GeriOnc designed for oncologists when discussing treatment options with elderly cancer patients. It aims to see if training doctors in this method is practical and well-received in real-world settings.See study design
What are the potential side effects?
Since this trial involves a communication tool rather than medication, there are no direct physical side effects expected from participation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a solid tumor cancer at any stage.
Select...
I am 65 years old or older.
Select...
I am willing to undergo a two-hour training session.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completed once at the end of study participation (approximately 18 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completed once at the end of study participation (approximately 18 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of audio-recorded decision-making discussions
Enrollment rate
Feasibility of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
+2 moreSecondary outcome measures
Acceptability of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
BC/WC-GeriOnc Intervention Adherence (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
BC/WC-GeriOnc Intervention Fidelity (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Lead-In (BC/WC-GeriOnc)Experimental Treatment1 Intervention
Lead-in phase oncologists will complete the BC/WC-GeriOnc communication tool training. Cancer treatment decision-making discussions will be recorded with 2 patients per oncologist and ask patients and oncologists to complete study questionnaires over one-month follow-up and one semi-structured interview about the decision-making process and communication.
Group II: Intervention (BC/WC-GeriOnc)Experimental Treatment1 Intervention
Intervention group oncologists will complete the BC/WC-GeriOnc communication tool training. Cancer treatment decision-making discussions will be recorded with 2 patients per oncologist to understand baseline oncologist practices and communication. Patients and oncologists will be asked to complete study questionnaires over a 2 month follow-up and 1 semi-structured interview. For each randomized oncologist, cancer treatment decision-making discussions will be recorded with 5 patients per oncologist. Both patients and oncologists will also be asked to complete study questionnaires over a 2 month follow-up and 1 semi-structured interview about the decision-making process and communication. Each patient will be given the option to select 1 caregiver to participate. Caregivers will be asked to complete study questionnaires and a semi-structured interview about their decision-making experience.
Group III: Waitlist ControlActive Control1 Intervention
Usual care will be provided to the patients, with optional training for the oncologists at study completion.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,459 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,829 Total Patients Enrolled
Mount Zion Health FundOTHER
12 Previous Clinical Trials
862 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My health status, organ function, or other illnesses do not affect my eligibility.You will need to meet with a medical oncologist in person or through a video call to discuss your treatment options.I have been diagnosed with a solid tumor cancer at any stage.I am 65 years old or older.You can speak, read, and write in English.I treat over 10 patients aged 65+ with solid tumors each year in an outpatient setting.I am willing to undergo a two-hour training session.I can understand and agree to the study's requirements.You must continue receiving treatment at a specific hospital affiliated with the study.You are a licensed medical oncology doctor who practices independently (fellows in training are not eligible).
Research Study Groups:
This trial has the following groups:- Group 1: Intervention (BC/WC-GeriOnc)
- Group 2: Waitlist Control
- Group 3: Lead-In (BC/WC-GeriOnc)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in this medical research program?
"Affirmative. Information on clinicaltrials.gov suggests that this medical trial is currently looking for participants, with the first posting being made on July 6th 2022 and last updated on November 18th of the same year. 96 patients are needed from 3 sites to complete recruitment goals."
Answered by AI
Are there still opportunities to participate in this scientific endeavor?
"This clinical trial is still open for recruitment, according to the information on clinicaltrials.gov - first posted on June 7th 2022 and last updated November 18th of that year."
Answered by AI
What aims does this experiment hope to fulfill?
"This medical experiment is timed at 3 months and seeks to gauge the efficacy of an audio-recorded decision making discussion. To further measure success, oncologists will complete Practitioner Opinion Surveys (15 items), Acceptability of Intervention Measure (4 items) and Intervention Appropriateness Measure (4 items). Each survey consists of a 5-point Likert scale from completely disagree to completely agree with higher scores indicating increased acceptability or appropriateness."
Answered by AI
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