Prostate CancerNCT03331068
French Validation of the Memorial Anxiety Scale for Patients With Prostate Cancer.
An observational study of Prostate Cancer, run by Institut Paoli-Calmettes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- online questionnaire of MAX-PC
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2016to 1 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists in adult patients with prostate cancer diagnosed within 12 months.
Who may be able to join
- Patients with prostate cancer diagnosed within 12 months
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- online questionnaire of MAX-PC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online questionnaire of MAX-PCBehavioural
Scale measuring of the anxiety specific of prostate cancer, French version.
| Study group | Role | What they receive |
|---|---|---|
| Patients with prostate cancer | online questionnaire of MAX-PC Receives: Behavioral: online questionnaire of MAX-PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start26 Apr 2016
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenaelle GRAVIS, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331068
- Sponsor's protocol ID
- MAC-PROSTATE-IPC 2016-009
- Status last verified
- Nov 2017
- First submitted
- 2 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memorial Anxiety Scale for Patients With Prostate Cancer: French Validation, Links With Quality Of Life and Future Temporal Perspective.
- ClinicalTrials.gov ID
- NCT03331068
- Acronym / sponsor ID
- MAC-PROSTATE-IPC 2016-009
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with prostate cancer | – | Behavioral: online questionnaire of MAX-PConline questionnaire of MAX-PC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists in adult patients with prostate cancer diagnosed within 12 months.
Key inclusion criteria (1 listed)
- Patients with prostate cancer diagnosed within 12 months
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online questionnaire of MAX-PCScale measuring of the anxiety specific of prostate cancer, French version. | Behavioural | Patients with prostate cancer |
Primary outcome
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.
3 secondary outcomes
Quality of Life (QoL) scores assessed by the SF-12 scale
Time frame: At inclusion
Anxiety score assessed by the HADS scale
Time frame: At inclusion
Depression score assessed by the HADS scale
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwenaelle GRAVIS, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total anxiety score assessed by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC scale) (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.