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Assessing Quality of Life of Patients With Prostate Cancer

E

European Organisation for Research and Treatment of Cancer (EORTC)

Status

Completed

Conditions

Prostate Cancer

Treatments

Other: QoL assessment

Study type

Observational

Funder types

NETWORK

Identifiers

NCT00041301
EORTC-30011 (Other Identifier)
EORTC-15011-30011
EORTC-15011 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients.

PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer.

Full description

OBJECTIVES:

  • Assess the scale structure, psychometric validity, and reliability of quality of life measurements using the EORTC QLQ-C30 and the prostate cancer-specific QLQ-PR25 questionnaires in patients with stage I-IV prostate cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease (local or locally advanced disease vs metastatic disease).

Patients complete EORTC QLQ-C30 and prostate cancer-specific QLQ-PR25 questionnaires before therapy and at 3 months after the start of therapy. Patients in stratum II also complete questionnaires at 6 months after the start of therapy.

PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

Enrollment

625 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer

  • Stratum I:

    • Clinically localized primary prostate cancer

      • T1-T3, G1-G3, N0, M0
      • Plan to undergo a radical prostatectomy OR
    • Local or locally advanced primary prostate cancer

      • T1-T4, G1-G3, N0, M0
      • Plan to undergo radiotherapy with curative intent
  • Stratum II:

    • Metastatic prostate cancer

      • T1-T4, G1-G3, N1, M0-M1 OR

      • T1-T4, G1-G3, N0-1, M1

      • Plan to receive hormonal treatment

        • No anti-androgen monotherapy
  • No cerebral metastases

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Mentally fit to complete a questionnaire
  • Literate in the language of the questionnaires
  • No psychological, familial, sociological, or geographical condition that would preclude compliance
  • No other concurrent malignancy except basal cell skin cancer
  • No concurrent participation in other quality of life investigations that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • See Disease Characteristics
  • No prior neoadjuvant hormonal treatment
  • Planned adjuvant hormonal therapy (orchiectomy, luteinizing hormone-releasing hormone analogue, or maximal androgen blockade) is allowed for patients in stratum I

Radiotherapy:

  • See Disease Characteristics
  • No interstitial radiotherapy
  • More than 2 years since prior radiotherapy (stratum II)

Surgery:

  • See Disease Characteristics
  • More than 2 years since prior prostatectomy (stratum II)

Other:

  • No prior treatment for prostate carcinoma

Trial design

625 participants in 1 patient group

QoL in prostate cancer
Description:
The study sample will be composed of a consecutive series of prostate cancer patients, stratified by stage of disease, local and locally advanced versus advanced (metastatic) disease, and undergoing active anti-tumor therapy. In order to increase sample homogeneity, and to facilitate evaluation of the responsiveness of the quality of life instruments to changes in patients' health status and symptoms experience over time, the subsample of patients with local or locally advanced disease will be restricted to those undergoing surgery (radical prostatectomy) or radiation therapy, and the subsample of metastatic disease patients will be limited to those receiving hormonal therapy.
Treatment:
Other: QoL assessment

Trial contacts and locations

33

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Data sourced from clinicaltrials.gov

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