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Shared Decision Making in Low Risk Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jason Efstathiou, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01673581
First received: August 15, 2012
Last updated: March 14, 2016
Last verified: March 2016
History of Changes
  Purpose
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.

Condition Intervention
Prostate Cancer
 Other: Survey

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Patient knowledge regarding the available treatment options for low-risk prostate cancer and their potential side effects. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Decisional conflict and informed decision making experienced by patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Enrollment: 141
Study Start Date: August 2012
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Low risk prostate cancer Other: Survey

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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673581

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jason A. Efstathiou, MD, DPhil Massachusetts General Hospital
  More Information

Responsible Party: Jason Efstathiou, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01673581     History of Changes
Other Study ID Numbers: 11-463 
Study First Received: August 15, 2012
Last Updated: March 14, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Low Risk

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 23, 2016