Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582842
First received: December 21, 2007
Last updated: August 27, 2013
Last verified: August 2013

December 21, 2007
August 27, 2013
May 2002
May 2014   (final data collection date for primary outcome measure)
Assessment of temporal trends in HRQOL according to intervention group [ Time Frame: study time points 3, 6, 9, 12, 15, 18, 24, 36, and 48 following treatment)and between 60 and 96 months. ] [ Designated as safety issue: No ]
Assessment of temporal trends in HRQOL according to intervention group [ Time Frame: study time points 3, 6, 9, 12, 15, 18, 24, 36, and 48 following treatment). ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00582842 on ClinicalTrials.gov Archive Site
  • Assessment of scale score differences between treatment groups [ Time Frame: 3, 6, 9, 12, 15, 18, 24, 36, 48 months and between 60 and 96 months ] [ Designated as safety issue: No ]
  • Describe the quality of life of long-term survivors [ Time Frame: 10 years post treatment ] [ Designated as safety issue: No ]
    of prostate cancer following treatment
Assessment of scale score differences between treatment groups [ Time Frame: 3, 6, 9, 12, 15, 18, 24, 36, 48 months ] [ Designated as safety issue: No ]
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Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer
Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer

The purpose of this study is to assess quality-of-life of men with prostate cancer. "Quality-of-life" means how you feel about your life as a result of your disease and its treatment. The investigators hope that this questionnaire will help show how prostate cancer treatments affect quality-of-life. It will help doctors and future patients to make better treatment choices. Some men may wish to have a more demanding treatment with a higher risk of harmful effects. Others may prefer a treatment that will have the smallest effect on their quality-of-life.

This questionnaire will help us measure these effects and decide which is the best treatment for a given patient.

The intent of the protocol is to assess health-related quality-of-life (HRQOL) in men treated for localized prostate cancer with 1 of 6 established management alternatives: external (XRT)or interstitial radiotherapy (IRT), open radical prostatectomy (RP), laparoscopic radical prostatectomy (LRP), combined radiotherapy and brachytherapy (Combined RT) or watchful waiting (WW). HRQOL is an important aspect of any treatment for prostate cancer due to the beliefs by many that cancer control rates are similar across common modalities and HRQOL reduction from treatment is substantial (1-5). Therefore, HRQOL appears to occupy a central role in the decision making process related to treatment selection.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All eligible MSKCC patients (including patients from the regional network sites: Commack, Basking Ridge, Rockville Centre and Sleepy Hollow) will be approached by consenting professionals and invited to participate in the study.

Prostate Cancer
  • Behavioral: Interview
    The phone interview will consist of the following items from the follow up questionnaire; 14, 16, 20, 32, 33, 46, 47, 60, and 65. An additional component of this study would be dispensing the HRQOL tool to long-term survivors 10 years or greater after the completion of therapy. The long term QoL study will be a cross-sectional assessment measuring HRQOL in prostate cancer survivors, free of disease at least ten years post-treatment. Patients will complete a questionnaire by selfreport focusing on assessment of HRQOL.
  • Behavioral: survey instruments using Web-Based Data Collection System (WBDC) survey content
    The content of the WBDC questionnaire will be similar to the paper form, no alteration in the wording, the order, or the formate of the items will be done. In addition, at the time of each outpatient clinic visit to MSKCC, these subjects will be able to login to WBDC using a computer located in the patient waiting-area, and enter their responses to the different items of the questionnaire if their clinic visit corresponds to any of the study time points 3, 6, 9, 12, 15, 18, 24, 36, and 48 following treatment). An additional component of this study would be dispensing the HRQOL tool to long-term survivors 10 years or greater after the completion of therapy. The long term QoL study will be a cross-sectional assessment measuring HRQOL in prostate cancer survivors, free of disease at least ten years post-treatment. Patients will complete a questionnaire by selfreport focusing on assessment of HRQOL.
  • 1
    Men with prostate cancer
    Intervention: Behavioral: Interview
  • 2
    Men with prostate cancer
    Intervention: Behavioral: survey instruments using Web-Based Data Collection System (WBDC) survey content
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1800
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of localized, untreated prostate cancer (clinical stages T1-3, Nx, M0)
  • ability to read the English language

Exclusion criteria:

  • other cancer diagnosis for the past three years, except for non-melanoma skin cancer
  • prior chemotherapy within the last three years; radiation therapy to the pelvis or prior pelvic surgery within the past three years
  • prior neoadjuvant therapy, such as hormones (Bicalutamide use for less than or equal to 1 month would not constitute exclusion from study entry)

For the cross-sectional component of the study, all patients identified to be free of disease at least ten years post -treatment will be considered eligible. Patients must have no clinical evidence of local, regional or distant recurrences. Patients must have the ability to read and understand English. Patients who received hormonal therapy will be eligible for the cross-sectional component of the study, but the duration of the hormonal therapy must be six months or less. the investigators have identified a cohort of patients who fit these criteria from our databases.

Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582842
02-042
No
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Peter Scardino, M.D. Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP