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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331068
• Other study ID #: MAC-PROSTATE-IPC 2016-009
• Status: Completed
• Phase: N/A
• First received: October 2, 2017
• Last updated: November 3, 2017
• Start date: April 26, 2016
• Est. completion date: November 1, 2017

Study information

• Verified date: November 2017
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with prostate cancer diagnosed within 12 months

Exclusion Criteria:

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• online questionnaire of MAX-PC
Scale measuring of the anxiety specific of prostate cancer, French version.

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total anxiety score assessed by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC scale)	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.	At inclusion
Secondary	Quality of Life (QoL) scores assessed by the SF-12 scale	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.	At inclusion
Secondary	Anxiety score assessed by the HADS scale	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.	At inclusion
Secondary	Depression score assessed by the HADS scale	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.	At inclusion