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

NCT02410291 | Completed Results

• 1 other identifier: Sunnybrook ID 123
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Latent Cancer (Prostate)

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month (patients will be followed until their treatment is complete)

Study Arms (2)

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.

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.

Interventions

Educational video OTHER

Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non- English speaking patients.
• Patients who refuse consent.
• Patients who are confused or who are cognitively unable to complete the questionnaire.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4K 3M8, Canada

Location

Related Publications (12)

• 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.

  PMID: 21425143 BACKGROUND

• 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.

  PMID: 24113055 BACKGROUND

• 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. doi: 10.1016/s0360-3016(98)00037-6.

  PMID: 9588921 BACKGROUND

• 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. doi: 10.1016/s0167-8140(99)00100-0.

  PMID: 10869739 BACKGROUND

• 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. doi: 10.1016/s0167-8140(98)00021-8.

  PMID: 9681892 BACKGROUND

• 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. doi: 10.1016/s0167-8140(01)00469-8.

  PMID: 12142088 BACKGROUND

• 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. doi: 10.1016/s0167-8140(02)00147-0.

  PMID: 12208568 BACKGROUND

• 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. doi: 10.1088/0031-9155/48/16/303.

  PMID: 12974577 BACKGROUND

• Fokdal 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.

  PMID: 15734208 BACKGROUND

• 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. doi: 10.1016/s0360-3016(03)00659-x.

  PMID: 12957271 BACKGROUND

• 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. doi: 10.1016/s0360-3016(03)00749-1.

  PMID: 14630262 BACKGROUND

• Dawdy 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.

  PMID: 27526692 DERIVED

Results Point of Contact

• Title: Krista Dawdy, Clinical Educator
• Organization: Sunnybrook Health Sciences Centre

krista.dawdy@sunnybrook.ca

416 480 6104

Study Officials

• Ewa Szumacher, FRCP(C), Med

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Educator, Radiation Therapy

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 7, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 20, 2017
• Results First Posted: February 20, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)