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Shared Decision Making in Low Risk Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01673581
Recruitment Status : Active, not recruiting
First Posted : August 28, 2012
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Efstathiou, Massachusetts General Hospital

Tracking Information
First Submitted Date August 15, 2012
First Posted Date August 28, 2012
Last Update Posted Date August 26, 2019
Study Start Date August 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2012)
Patient knowledge regarding the available treatment options for low-risk prostate cancer and their potential side effects. [ Time Frame: 2 years ]
Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
Original Primary Outcome Measures
 (submitted: August 23, 2012)
To assess patient knowledge regarding the available treatment options for low-risk prostate cancer and their potential side effects. [ Time Frame: 2 years ]
Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
Change History Complete list of historical versions of study NCT01673581 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 4, 2012)
  • Decisional conflict and informed decision making experienced by patients. [ Time Frame: 2 years ]
    Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
  • Patient health related worry. [ Time Frame: 2 years ]
    Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
  • Patient views on cancer control for their treatment choice. [ Time Frame: 2 years ]
    Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
  • Patient satisfaction with their treatment choice. [ Time Frame: 2 years ]
    Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
Original Secondary Outcome Measures
 (submitted: August 23, 2012)
  • To assess decisional conflict and informed decision making experienced by patients. [ Time Frame: 2 years ]
    Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
  • To assess patient health related worry. [ Time Frame: 2 years ]
    Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
  • To assess patient views on cancer control for their treatment choice. [ Time Frame: 2 years ]
    Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
  • To assess patient satisfaction with their treatment choice. [ Time Frame: 2 years ]
    Investigators will assess the impact of an informational website developed specifically to assist low-risk prostate cancer patients with knowledge of their disease and treatment options. This will be measured by patient responses to questionnaires compiled from validated sources.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Shared Decision Making in Low Risk Prostate Cancer
Official Title Shared Decision Making: A Study Assessing the Benefit of a Web Based Aid Presenting Treatment Options for Patients With Low Risk Prostate Cancer
Brief Summary This study will evaluate the usefulness of an informational website designed to educate patients with prostate cancer about their options for treatment. The investigators hope that this website will assist patients with making informed decisions about their care and improving their satisfaction with the treatments they choose.
Detailed Description

Investigators will first ask patients to answer a series of questions to assess their wishes regarding treatment, knowledge about their disease and discussion with the physicians at initial patient visit. This initial survey should take approximately 20 minutes. Once patients have selected a treatment path investigators will contact them again and ask them to fill out a short 10-minute survey online or by mail. Investigators will contact patients by phone 2 weeks after their initial visit to see if they have made a decision. If not, investigators will contact patients by phone every 2 weeks or at an interval that works for the patient's schedule. Finally, 3 months after the initial visit today investigators will contact patients for the last time and again ask you to fill out a short 10-minute survey online or by mail.

Once patients have completed the final survey there are no future surveys planned. Investigators may contact patients by phone in the future to ask them to participate in another study.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Low risk prostate cancer patients seen wthin the Claire & John Bertucci Center for Genitourinary Cancers multidisciplinary clinic at MGH.
Condition Prostate Cancer
Intervention Other: Survey
Study Groups/Cohorts Low risk prostate cancer
Intervention: Other: Survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: March 14, 2016)
141
Original Estimated Enrollment
 (submitted: August 23, 2012)
150
Study Completion Date Not Provided
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma
  • Internet access
  • Able to read and understand English

Exclusion Criteria:

  • Evidence of nodal metastases
  • Evidence of distant metastases
  • Prior surgery, chemotherapy, pelvic radiation or prostate brachytherapy for prostate cancer
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01673581
Other Study ID Numbers 11-463
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jason Efstathiou, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jason A. Efstathiou, MD, DPhil Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2019