Latent Cancer (Prostate)NCT02410291
Impact on Instructional Video on Patients' Compliance With Preparation During CT Planning for Prostate Cancer
A study testing Educational video in people with Latent Cancer (Prostate), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Latent Cancer (Prostate)
- What is being tested?
- Educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- All patients who are referred for planning simulation for prostate cancer IMRT will be invited to participate
- Patients who speak and read English will be invited to participate.
- Have the ability to complete the questionnaire.
Who cannot join
- Non- English speaking patients.
- Patients who refuse consent.
- Patients who are confused or who are cognitively unable to complete the questionnaire.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4K 3M8
About this study
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.
Read the detailed description
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.
- 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.
- 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).
- 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.
- Conditions
- Latent Cancer (Prostate)
- Being tested
- Educational video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study. Receives: Other: Educational video |
| Control group | No intervention | Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients' satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists' satisfaction with patients' rectal preparation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Whom Had Proper Preparation After Education Intervention
patients will receive a questionnaire to assess their satisfaction of their appointment. CT scans will be assessed for compliance of preparation based on departmental guidelines and rescans required.
Measured: 1 month (patients will be followed until their treatment is complete)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Latent Cancer (Prostate)Studies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krista Dawdy, Sunnybrook Health Sciences Centre
- Investigators
- Ewa Szumacher, FRCP(C), Med, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410291
- Sponsor's protocol ID
- Sunnybrook ID 123
- Status last verified
- Dec 2016
- First submitted
- 30 Mar 2015
- Last updated
- 20 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alicikus ZA, Yamada Y, Zhang Z, Pei X, Hunt M, Kollmeier M, Cox B, Zelefsky MJ. Ten-year outcomes of high-dose, intensity-modulated radiotherapy for localized prostate cancer. Cancer. 2011 Apr 1;117(7):1429-37. doi: 10.1002/cncr.25467. Epub 2010 Nov 8.
PubMed 21425143Michalski JM, Yan Y, Watkins-Bruner D, Bosch WR, Winter K, Galvin JM, Bahary JP, Morton GC, Parliament MB, Sandler HM. Preliminary toxicity analysis of 3-dimensional conformal radiation therapy versus intensity modulated radiation therapy on the high-dose arm of the Radiation Therapy Oncology Group 0126 prostate cancer trial. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):932-8. doi: 10.1016/j.ijrobp.2013.07.041. Epub 2013 Oct 8.
PubMed 24113055Boersma LJ, van den Brink M, Bruce AM, Shouman T, Gras L, te Velde A, Lebesque JV. Estimation of the incidence of late bladder and rectum complications after high-dose (70-78 GY) conformal radiotherapy for prostate cancer, using dose-volume histograms. Int J Radiat Oncol Biol Phys. 1998 Apr 1;41(1):83-92. doi: 10.1016/s0360-3016(98)00037-6.
PubMed 9588921Zelefsky MJ, Fuks Z, Happersett L, Lee HJ, Ling CC, Burman CM, Hunt M, Wolfe T, Venkatraman ES, Jackson A, Skwarchuk M, Leibel SA. Clinical experience with intensity modulated radiation therapy (IMRT) in prostate cancer. Radiother Oncol. 2000 Jun;55(3):241-9. doi: 10.1016/s0167-8140(99)00100-0.
PubMed 10869739Fiorino C, Reni M, Bolognesi A, Cattaneo GM, Calandrino R. Intra- and inter-observer variability in contouring prostate and seminal vesicles: implications for conformal treatment planning. Radiother Oncol. 1998 Jun;47(3):285-92. doi: 10.1016/s0167-8140(98)00021-8.
PubMed 9681892Fiorino C, Vavassori V, Sanguineti G, Bianchi C, Cattaneo GM, Piazzolla A, Cozzarini C. Rectum contouring variability in patients treated for prostate cancer: impact on rectum dose-volume histograms and normal tissue complication probability. Radiother Oncol. 2002 Jun;63(3):249-55. doi: 10.1016/s0167-8140(01)00469-8.
PubMed 12142088Fiorino C, Cozzarini C, Vavassori V, Sanguineti G, Bianchi C, Cattaneo GM, Foppiano F, Magli A, Piazzolla A. Relationships between DVHs and late rectal bleeding after radiotherapy for prostate cancer: analysis of a large group of patients pooled from three institutions. Radiother Oncol. 2002 Jul;64(1):1-12. doi: 10.1016/s0167-8140(02)00147-0.
PubMed 12208568Fiorino C, Gianolini S, Nahum AE. A cylindrical model of the rectum: comparing dose-volume, dose-surface and dose-wall histograms in the radiotherapy of prostate cancer. Phys Med Biol. 2003 Aug 21;48(16):2603-16. doi: 10.1088/0031-9155/48/16/303.
PubMed 12974577Fokdal L, Honore H, Hoyer M, von der Maase H. Dose-volume histograms associated to long-term colorectal functions in patients receiving pelvic radiotherapy. Radiother Oncol. 2005 Feb;74(2):203-10. doi: 10.1016/j.radonc.2004.11.001. Epub 2004 Nov 25.
PubMed 15734208Foppiano F, Fiorino C, Frezza G, Greco C, Valdagni R; AIRO National Working Group on Prostate Radiotherapy. The impact of contouring uncertainty on rectal 3D dose-volume data: results of a dummy run in a multicenter trial (AIROPROS01-02). Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):573-9. doi: 10.1016/s0360-3016(03)00659-x.
PubMed 12957271Miralbell R, Taussky D, Rinaldi O, Lomax A, Canales S, Escude L, Nouet P, Ozsoy O, Rouzaud M. Influence of rectal volume changes during radiotherapy for prostate cancer: a predictive model for mild-to-moderate late rectal toxicity. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1280-4. doi: 10.1016/s0360-3016(03)00749-1.
PubMed 14630262Dawdy K, Bonin K, Russell S, Ryzynski A, Harth T, Townsend C, Liu S, Chu W, Cheung P, Chung H, Morton G, Vesprini D, Loblaw A, Cao X, Szumacher E. Developing and Evaluating Multimedia Patient Education Tools to Better Prepare Prostate-Cancer Patients for Radiotherapy Treatment (Randomized Study). J Cancer Educ. 2018 Jun;33(3):551-556. doi: 10.1007/s13187-016-1091-5.
PubMed 27526692
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02410291
- Acronym / sponsor ID
- Sunnybrook ID 123
- Conditions
- Latent Cancer (Prostate)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 20 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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.
- 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).
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Educational videoPatients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study. |
| Control group | No intervention | –Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients' satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists' satisfaction with patients' rectal preparation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- All patients who are referred for planning simulation for prostate cancer IMRT will be invited to participate
- Patients who speak and read English will be invited to participate.
- Have the ability to complete the questionnaire.
Key exclusion criteria (3 listed)
- Non- English speaking patients.
- Patients who refuse consent.
- Patients who are confused or who are cognitively unable to complete the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoPatients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video | Other | Experimental group |
Primary outcome
Number of Participants Whom Had Proper Preparation After Education Intervention
Time frame: 1 month (patients will be followed until their treatment is complete)
patients will receive a questionnaire to assess their satisfaction of their appointment. CT scans will be assessed for compliance of preparation based on departmental guidelines and rescans required.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21425143Alicikus ZA, Yamada Y, Zhang Z, Pei X, Hunt M, Kollmeier M, Cox B, Zelefsky MJ. Ten-year outcomes of high-dose, intensity-modulated radiotherapy for localized prostate cancer. Cancer. 2011 Apr 1;117(7):1429-37. doi: 10.1002/cncr.25467. Epub 2010 Nov 8.
- Background: PubMed 24113055Michalski JM, Yan Y, Watkins-Bruner D, Bosch WR, Winter K, Galvin JM, Bahary JP, Morton GC, Parliament MB, Sandler HM. Preliminary toxicity analysis of 3-dimensional conformal radiation therapy versus intensity modulated radiation therapy on the high-dose arm of the Radiation Therapy Oncology Group 0126 prostate cancer trial. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):932-8. doi: 10.1016/j.ijrobp.2013.07.041. Epub 2013 Oct 8.
- Background: PubMed 9588921Boersma LJ, van den Brink M, Bruce AM, Shouman T, Gras L, te Velde A, Lebesque JV. Estimation of the incidence of late bladder and rectum complications after high-dose (70-78 GY) conformal radiotherapy for prostate cancer, using dose-volume histograms. Int J Radiat Oncol Biol Phys. 1998 Apr 1;41(1):83-92. doi: 10.1016/s0360-3016(98)00037-6.
- Background: PubMed 10869739Zelefsky MJ, Fuks Z, Happersett L, Lee HJ, Ling CC, Burman CM, Hunt M, Wolfe T, Venkatraman ES, Jackson A, Skwarchuk M, Leibel SA. Clinical experience with intensity modulated radiation therapy (IMRT) in prostate cancer. Radiother Oncol. 2000 Jun;55(3):241-9. doi: 10.1016/s0167-8140(99)00100-0.
- Background: PubMed 9681892Fiorino C, Reni M, Bolognesi A, Cattaneo GM, Calandrino R. Intra- and inter-observer variability in contouring prostate and seminal vesicles: implications for conformal treatment planning. Radiother Oncol. 1998 Jun;47(3):285-92. doi: 10.1016/s0167-8140(98)00021-8.
- Background: PubMed 12142088Fiorino C, Vavassori V, Sanguineti G, Bianchi C, Cattaneo GM, Piazzolla A, Cozzarini C. Rectum contouring variability in patients treated for prostate cancer: impact on rectum dose-volume histograms and normal tissue complication probability. Radiother Oncol. 2002 Jun;63(3):249-55. doi: 10.1016/s0167-8140(01)00469-8.
- Background: PubMed 12208568Fiorino C, Cozzarini C, Vavassori V, Sanguineti G, Bianchi C, Cattaneo GM, Foppiano F, Magli A, Piazzolla A. Relationships between DVHs and late rectal bleeding after radiotherapy for prostate cancer: analysis of a large group of patients pooled from three institutions. Radiother Oncol. 2002 Jul;64(1):1-12. doi: 10.1016/s0167-8140(02)00147-0.
- Background: PubMed 12974577Fiorino C, Gianolini S, Nahum AE. A cylindrical model of the rectum: comparing dose-volume, dose-surface and dose-wall histograms in the radiotherapy of prostate cancer. Phys Med Biol. 2003 Aug 21;48(16):2603-16. doi: 10.1088/0031-9155/48/16/303.
- Background: PubMed 15734208Fokdal L, Honore H, Hoyer M, von der Maase H. Dose-volume histograms associated to long-term colorectal functions in patients receiving pelvic radiotherapy. Radiother Oncol. 2005 Feb;74(2):203-10. doi: 10.1016/j.radonc.2004.11.001. Epub 2004 Nov 25.
- Background: PubMed 12957271Foppiano F, Fiorino C, Frezza G, Greco C, Valdagni R; AIRO National Working Group on Prostate Radiotherapy. The impact of contouring uncertainty on rectal 3D dose-volume data: results of a dummy run in a multicenter trial (AIROPROS01-02). Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):573-9. doi: 10.1016/s0360-3016(03)00659-x.
- Background: PubMed 14630262Miralbell R, Taussky D, Rinaldi O, Lomax A, Canales S, Escude L, Nouet P, Ozsoy O, Rouzaud M. Influence of rectal volume changes during radiotherapy for prostate cancer: a predictive model for mild-to-moderate late rectal toxicity. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1280-4. doi: 10.1016/s0360-3016(03)00749-1.
- Derived from this study: PubMed 27526692Dawdy K, Bonin K, Russell S, Ryzynski A, Harth T, Townsend C, Liu S, Chu W, Cheung P, Chung H, Morton G, Vesprini D, Loblaw A, Cao X, Szumacher E. Developing and Evaluating Multimedia Patient Education Tools to Better Prepare Prostate-Cancer Patients for Radiotherapy Treatment (Randomized Study). J Cancer Educ. 2018 Jun;33(3):551-556. doi: 10.1007/s13187-016-1091-5.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Identify Genes/Pathways Responsible for Progression From Low Risk to Higher Risk Prostate Cancer
Prostate Cancer Stage I
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Szumacher, FRCP(C), Med principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Latent Cancer (Prostate), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Whom Had Proper Preparation After Education Intervention (time frame: 1 month (patients will be followed until their treatment is complete)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02410291, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.