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Clinical Trials/NCT01673581
NCT01673581
Unknown
N/A

Shared Decision Making: A Study Assessing the Benefit of a Web Based Aid Presenting Treatment Options for Patients With Low Risk Prostate Cancer

Massachusetts General Hospital1 site in 1 country141 target enrollmentAugust 2012
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Massachusetts General Hospital
Enrollment
141
Locations
1
Primary Endpoint
Patient knowledge regarding the available treatment options for low-risk prostate cancer and their potential side effects.
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
December 2015
Last Updated
6 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jason Efstathiou

Principal Investigator

Massachusetts General Hospital

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Patient views on cancer control for their treatment choice.(2 years)
  • Decisional conflict and informed decision making experienced by patients.(2 years)
  • Patient health related worry.(2 years)
  • Patient satisfaction with their treatment choice.(2 years)

Study Sites (1)

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