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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13298
    • Institut Paoli Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The study population consists in adult patients with prostate cancer diagnosed within 12 months.

Description

Inclusion Criteria:

• Patients with prostate cancer diagnosed within 12 months

Exclusion Criteria:

N/A

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2016
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (ACTUAL): November 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MAC-PROSTATE-IPC 2016-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No