Shared Decision Making in Low Risk Prostate Cancer
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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 |
- 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.
- 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.
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | September 2014 (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 |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Low risk prostate cancer patients seen wthin the Claire & John Bertucci Center for Genitourinary Cancers multidisciplinary clinic at MGH.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01673581
| Contact: Jason Efstathiou, MD, DPhil | 6177241160 | jefstathiou@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Jason Efstathiou, MD, DPhil 617-724-1160 jefstathiou@partners.org | |
| Principal Investigator: Jason Efstathiou, MD, DPhil | |
| Principal Investigator: | Jason A. Efstathiou, MD, DPhil | Massachusetts General Hospital |
More Information
No publications provided
| 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: | April 11, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Low Risk |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Diseases, Male Genital Neoplasms, Male Neoplasms |
Neoplasms by Site Prostatic Diseases Urogenital Neoplasms |
ClinicalTrials.gov processed this record on February 27, 2015