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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331068
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Behavioral: online questionnaire of MAX-PC

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Memorial Anxiety Scale for Patients With Prostate Cancer: French Validation, Links With Quality Of Life and Future Temporal Perspective.
Actual Study Start Date : April 26, 2016
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with prostate cancer
online questionnaire of MAX-PC
Behavioral: online questionnaire of MAX-PC
Scale measuring of the anxiety specific of prostate cancer, French version.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists in adult patients with prostate cancer diagnosed within 12 months.
Criteria

Inclusion Criteria:

  • Patients with prostate cancer diagnosed within 12 months

Exclusion Criteria:

N/A


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331068


Locations
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France
Institut Paoli Calmettes
Marseille, France, 13298
Sponsors and Collaborators
Institut Paoli-Calmettes
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Gwenaelle GRAVIS, MD Institut Paoli-Calmettes
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03331068    
Other Study ID Numbers: MAC-PROSTATE-IPC 2016-009
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases