Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001131741
Ethics application status
Approved
Date submitted
9/07/2022
Date registered
17/08/2022
Date last updated
17/08/2022
Date data sharing statement initially provided
17/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of the Prostactive intervention for self-management of symptoms in men with prostate cancer in treatment.
Scientific title
Effectiveness of the Prostactive intervention for self-management of symptoms in men with prostate cancer in treatment.
Secondary ID [1] 307694 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 326957 0
symptoms self-management 326958 0
health promotion/education 327214 0
Condition category
Condition code
Cancer 324141 324141 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will receive an educational intervention that consists of 4 sessions in which it will be explained what prostate cancer consists of and the different types of treatments; in the second session we will talk about urinary and sexual symptoms and how to manage them; In the third session, sexual and cognitive symptoms will be discussed, and in the fourth, the importance of social support will be explained.

Training mode: It will be carried out through individual face-to-face sessions in which a flip-chart presentations and short videos will be used: what radiotherapy consists of; how to perform Keguel exercises and videos related to the experience of men during radiotherapy treatment. Each one in one session.

Frequency and duration of program administration: each session will last between 30 and 40 minutes each week.

The strategy used to comply with the intervention will be through the signature of the participant at the end of the intervention.
Intervention code [1] 323990 0
Treatment: Other
Comparator / control treatment
- The usual care provided in the institution that consists of follow-up by the nurse through weekly controls in which general recommendations are provided on the management of bladder catheter in case of patients in postoperative prostatectomy, diet, complications, care during and after the procedures (surgery and radiotherapy), medication management. This information is delivered to the family member in person and through institutional booklets.
Control group
Active

Outcomes
Primary outcome [1] 331956 0
Functional Evaluation of Cancer Therapy for Prostate Cancer Patients – FACT-P
Timepoint [1] 331956 0
4 weeks after completing treatment
Secondary outcome [1] 411729 0
General scale of self-efficacy.
Timepoint [1] 411729 0
4 weeks after completing treatment
Secondary outcome [2] 411730 0
The expanded prostate cancer index composite
Timepoint [2] 411730 0
4 weeks after completing treatment

Eligibility
Key inclusion criteria
Men who have been diagnosed with localized prostate cancer who are being treated with radiotherapy in the first six weeks, post-operative radical prostatectomy and/or adjuvant therapy.
Men with prostate cancer with Karnofsky activity level of 60% or higher.
Patients with localized and locally advanced CP in stages T1 to T3b.
Phone access.
Men who wish to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Adults with a history of brain injury, dementia, or psychiatric illness that interfere with proper assessment of symptom self-management and functional performance outcomes.
Present recurrence or progression of prostate cancer to a more advanced stage since the physical and cognitive symptoms are different from those expected in treatment phases with curative intent.
Being treated for another type of cancer because the symptoms are related to the type of treatment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The collected data will initially be typed in Excel, and later exported to the SPSS statistics version 22 program. Each group (experimental and control) will be performed descriptive statistics on variables with measures of central tendency and dispersion such as mean, standard deviation, interquartile ranges. The comparison of the groups (experiment and control) will be carried out with parametric tests, as long as they satisfy the criteria of homoscedasticity and normality. If this is not the case, non-parametric tests will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment outside Australia
Country [1] 24884 0
Colombia
State/province [1] 24884 0
Bogotá D.C

Funding & Sponsors
Funding source category [1] 311806 0
Government body
Name [1] 311806 0
Minciencias
Country [1] 311806 0
Colombia
Primary sponsor type
University
Name
Universidad Nacional de Colombia
Address
Carrera 45 N° 26-85 (Teusaquillo - Bogotá)
Country
Colombia
Secondary sponsor category [1] 313432 0
Individual
Name [1] 313432 0
Lina Rocío Corredor Parra
Address [1] 313432 0
Universidad Nacional de Colombia
Carrera 45 N° 26-85 (Teusaquillo - Bogotá)
Country [1] 313432 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311250 0
Comité de Ética en Investigación de la Facultad de Enfermería Universidad Nacional de Colombia
Ethics committee address [1] 311250 0
Ethics committee country [1] 311250 0
Colombia
Date submitted for ethics approval [1] 311250 0
10/11/2021
Approval date [1] 311250 0
03/12/2021
Ethics approval number [1] 311250 0
AVAL 027-21

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120458 0
Mrs Lina Rocío Corredor Parra
Address 120458 0
Universidad Nacional de Colombia
Carrera 45 N° 26-85 (Teusaquillo - Bogotá)
Country 120458 0
Colombia
Phone 120458 0
+5713165000
Fax 120458 0
Email 120458 0
[email protected]
Contact person for public queries
Name 120459 0
Lina Rocío Corredor Parra
Address 120459 0
Universidad Nacional de Colombia
Carrera 45 N° 26-85 (Teusaquillo - Bogotá)
Country 120459 0
Colombia
Phone 120459 0
+5713165000
Fax 120459 0
Email 120459 0
[email protected]
Contact person for scientific queries
Name 120460 0
Lina Rocío Corredor Parra
Address 120460 0
Universidad Nacional de Colombia
Carrera 45 N° 26-85 (Teusaquillo - Bogotá)
Country 120460 0
Colombia
Phone 120460 0
+5713007538408
Fax 120460 0
Email 120460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.