Impact on Instructional Video on Patients' Compliance With Preparation During CT Planning for Prostate Cancer

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02410291
• Other study ID #: Sunnybrook ID 123
• Status: Active, not recruiting
• Phase: N/A
• First received: March 30, 2015
• Last updated: May 31, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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 . 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older

2. All patients who are referred for planning simulation for prostate cancer IMRT will be invited to participate

3. Patients who speak and read English will be invited to participate.

4. Have the ability to complete the questionnaire.

Exclusion Criteria:

1. Non- English speaking patients.

2. Patients who refuse consent.

3. Patients who are confused or who are cognitively unable to complete the questionnaire.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Latent Cancer (Prostate)
• Prostatic Neoplasms

Intervention

Other:
• Educational video
Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video

Locations

Country	Name	City	State
Canada	Odette Cancer Centre, Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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. — View Citation

Boersma 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. — View Citation

Fiorino 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. — View Citation

Fiorino 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. — View Citation

Fiorino 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. — View Citation

Fiorino 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. — View Citation

Fokdal L, Honoré H, Høyer 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. Epub 2004 Nov 25. — View Citation

Foppiano 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. — View Citation

Michalski 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. — View Citation

Miralbell 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. — View Citation

Zelefsky 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved patient education	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.	1 month (patients will be followed until their treatment is complete)	No
Secondary	improved patient preparation for the CT planning scan	CT scans will be assessed for compliance of preparation based on departmental guidelines and rescans required.	1 month(patients will be followed until their treatment is complete)	No