Latent Cancer (Prostate) Clinical Trial
Official title:
Empowering Patients Through Education- Online, Written, and Personal Education Resource for Prostate Cancer Patients Who Need Radiation Therapy to Ensure Patient Preparedness (Compliance and Understanding) for Their Simulation and Treatment
Rectal toxicity limits dose escalated intensity modulated radiotherapy (IMRT) for prostate cancer. The dose volume constraints that predict for rectal toxicity require minimizing prostate motion and rectum and bladder filling of IMRT .5-15 . The volumetric changes and internal organ motion during prostate IMRT increases risk of PSA failure in patients with large rectums at the planning CT scans. Patient preparation for IMRT planning is crucial .The literature is limited regarding the effectiveness of educational intervention with behavioral reinforcement for patients, and a gap if exists literacy level is considered. Patients often cannot comprehend verbal or written instructions and have difficulties following through with recommended regimens.23 Using multimedia such as Internet, audio-visual media such as DVD and even the telephone can enhance patients' knowledge and understanding about importance of preparation for IMRT for prostate ca. Thomas's study showed that in patients undergoing radiotherapy and chemotherapy, the video group had lower anxiety scores compared with the non video group. At SOCC patients have been provided with verbal information about bladder and rectum preparation for prostate planning CT scan and IMRT. Patients should have a "fullish" bladder and empty rectum at the time of CT simulation. If the rectal diameter is > 4cm, the patient will be asked to empty his stool/gas and re-scanned. The 3- months review of patients preparedness for prostate IMRT showed that only 13/55 patients were adequately prepared but 42/55 (76%) of patients needed to be re-scanned due to inadequate bladder (21/42, 50%) or rectum filling 28/42, 67%) . Also, 2/13 (15%) patients were still not prepared at the second resimulation despite that they received a phone call with the instructions. The investigators plan to investigate if a multimedia education strategy will decrease costly resimulation rate for patients with prostate cancer.
An estimated 23,600 men will be diagnosed with prostate cancer in Canada in 2014. This
represents 24% of all new cancer cases in men in 2014. The SOCC treats 1000 patients with
prostate cancer annually. Patients who fail to follow instructions for the initial prostate
planning CT scan need to return to be rescanned at a later date. Additional CTs can increase
patients' parking and transportation costs and may increase their anxiety. Rescanning may
also cause stress to radiation therapists due to unsuccessful planning, increase costs to
the cancer centre for the additional time of radiation therapists and increase the planning
CT wait time for other patients. Thus improving patients' preparedness for the prostate
planning CT scan will reduce costs for patients and the hospital, reduce anxiety and stress
for both patients and practitioners, reduce CT scan wait times, maximize the accuracy of
prostate IMRT. In a study of 220 patients receiving chemotherapy or radiotherapy, Thomas
used video education and the Hospital Anxiety and Depression Scale (HAD) and found a
significant correlation between satisfaction and reduced overall treatment related anxiety
in the video group22.
Purpose To determine the effectiveness of the introduction of a video on patient
preparedness for patients receiving a CT Scan for radiotherapy to the prostate.
Methods The project will consist of three phases: video production, experiment and data
collection, and analysis and dissemination.
1. Video production - The investigators will produce the instructional video, test the
video, and revise based on initial feedback. Christopher Townsend and Sunnybrook Media
will produce the video using the script written by Agnes Ryzynski, with input from team
members. The script will highlight the importance of rectal and bladder preparation
prior and during the planning CT scans. Images will be presented showing both normal
and abnormal preparation examples, instructing patients how to prepare for the planning
CT scan. The video will be tested by patients and radiation oncologists, nurses and
radiation therapists prior to launch.
2. Experiment and data collection - The investigators will use a control experimental
group design. The RA will recruit sixty participants at their pre-planning appointment
date or via telephone. The RA will present the study rationale; those who agree to
participate will sign the study consent, and be assigned a study entry number.
Participants will be randomly assigned to either the control group or the experimental
group. The sample size was calculated based on the observed proportion of patients
needed to be rescanned: 0.76 (42/55). To have a treatment group with a proportion of
0.38 who needed to be rescanned, a 50% decrease, the investigators will need at least
25 patients in each group to have a power of 0.8, given a 0.05 significance level. To
account for study attrition (no more than 20% loss of participants), the investigators
will require 30 subjects per group to observe a large treatment effect (e.g. 50%
decreases in the proportion of rescanning).
3. Data analysis and dissemination - A statistical analysis will be conducted on the
patient preparedness data. The investigators will conduct quantitative analysis of the
evaluations form using a Likert scale. Patients' evaluations will also contain open
ended questions to capture patients' comments about their experiences during the study.
The investigators will analyze the details about patients' and radiation therapists'
satisfaction and patients' knowledge about the video content.
Confidentiality Patient confidentiality will be assured. All patients will have assigned a
study number and their names will not be disclosed at any time. All study data will be kept
in a locked cabinet, that only the investigators have access to.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care