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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interview

Behavioral

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.

survey instruments using Web-Based Data Collection System (WBDC) survey content

Behavioral

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.

Primary outcomes

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.

Secondary outcomes

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
Describe the quality of life of long-term survivors

Time frame: 10 years post treatment

of prostate cancer following treatment

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2002
Primary completion: 2022
Study completion: 2022
First posted: Dec 28, 2007
Registry last updated: Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed