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Completed

NCT Number: NCT03331068

French Validation of the Memorial Anxiety Scale for Patients With Prostate Cancer.

A specific scale allowing the measure of anxiety of patients with protate cancer has been designed and validated but the French version needs to be validated. This study aims at validating the French translation of this scale.

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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

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Institut Paoli Calmettes

Marseille, 13298, France

About this study

The psychological difficulties encountered by patients with prostate cancer are widely known. There are, however, problems in the identification of certain disorders that require appropriate psychological management. In order to diagnose patients with anxiety more finely, a prostate cancer-specific anxiety measurement scale (MAX-PC) was developed and validated. This scale includes three sub-dimensions: anxiety related to prostate cancer, anxiety related to the PSA assessment and fear of recurrence. This scale generally has good psychometric properties which are found in different populations and in different countries. The dimensions of the MAX-PC correlate with other anxiety measurement scales such as Beck or HADS, but do not show redundancy: it captures a specific anxiety related to the experience of patients with prostate cancer.

To date, this sclae is not validated in French, and its use in the frame of clinical trials or in routine practice require a first validation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with prostate cancer diagnosed within 12 months

Exclusion criteria

N/A

Treatment and study plan

online questionnaire of MAX-PC

Behavioral

Scale measuring of the anxiety specific of prostate cancer, French version.

Primary outcomes

  1. Total anxiety score assessed by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC scale)

    Time frame: At inclusion

    The scale is divided in 3 subscales: Prostate cancer Anxiety ; PSA anxiety and Fear of Recurrence. The total score of the scale ranges from 0 to 54, with 54 indicating maximum anxiety. Scores of the Prostate anxiety scale range from 0 to 33 ; with 33 indicating maximum anxiety. Scores of the PSA anxiety scale range from 0 to 9 ; with 9 indicating maximum anxiety. Score of the Fear of Recurrence scale range from 0 to 12; with 12 indicating maximum anxiety. The total score is the sum of the 3 subscales scores.

Secondary outcomes

  1. Quality of Life (QoL) scores assessed by the SF-12 scale

    Time frame: At inclusion

    12-item Short Form Health Survey (SF12), is a multipurpose generic measure oh health status. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.

    Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100 where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Higher values represent a better outcome.

  2. Anxiety score assessed by the HADS scale

    Time frame: At inclusion

    The scores for anxiety can range from 0 to 21, depending on the presence and severity of the symptom. Patients with a score higher than 7 are detected as having at least mild anxiety.

  3. Depression score assessed by the HADS scale

    Time frame: At inclusion

    The scores for depression can range from 0 to 21, depending on the presence and severity of the symptom. Patients with a score higher than 7 are detected as having at least mild depression.

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Memorial Anxiety Scale for Patients With Prostate Cancer: French Validation, Links With Quality Of Life and Future Temporal Perspective.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2017
Registry last updated
Nov 7, 2017

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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