Neoplasms Undergoing ChemotherapyBI-PORTNCT02075580
Totally Implantable Venous Access Devices: Quality of Life and Body Image
A study testing psychological support (interactive/cognitive strategies) in people with Neoplasms Undergoing Chemotherapy, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial summary
Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients modify body image and self-representation. Therefore, the purpose of this study is to evaluate the efficacy of psychological intervention on patients undergone this surgical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neoplasms Undergoing Chemotherapy
- What is being tested?
- psychological support (interactive/cognitive strategies)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Dec 2018
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neoplastic patients
- adults
- not visible demolitive interventions
- not psychopathological diagnosis
- language understanding
Who cannot join
- not neoplastic patients
- psychopathological diagnosis
- language misunderstanding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Totally Implantable Venous Access Devices (TIVAD): Impact on Quality of Life and Body Image
Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients modify body image and self-representation. Therefore, the purpose of this study is to evaluate the efficacy of psychological intervention on patients undergone this surgical practice.
- Conditions
- Neoplasms Undergoing Chemotherapy
- Being tested
- psychological support (interactive/cognitive strategies)
- Keywords
- cancer, quality of life, body-image, subcutaneous-implant
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological support (interactive/cognitive strategies)Behavioural
- cognitive/behavioural intervention (6 times starting from hospital admission, in 90 days; for arm of intervention)
- metacognitive techniques (6 times starting from hospital admission, in 90 days; for arm of intervention)
- psychoeducational intervention (6 times starting from hospital admission; for arm of intervention)
- questionnaires: EORTC questionnaires and a written structured interview (3 times: hospital admission,15 days after surgical intervention, 90 days after intervention; in both arms)
| Study group | Role | What they receive |
|---|---|---|
| psychological support | Experimental | Arm A will undergo psychological support and standard care prior and post TIVAD (Totally Implantable Venous Access Devices) insertion Arm B will undergo standard care prior and post TIVAD insertion Receives: Behavioral: psychological support (interactive/cognitive strategies) |
| standard care | No intervention | this arm does not receive psychological support before and after Totally Implantable Venous Access Devices positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generic and quality of life and body image
EORTC (European Organization for Research and Treatment of Cancer) questionnaire:
BR23 (Breast questionnaire, used just for BI scale, that is Body Image items)
Measured: 15 days
Secondary outcomes (1)
Satisfaction with care
EORTC (European Organization for Research and Treatment of Cancer) questionnaire: QLQ C30 (Quality of Life Questionnaire)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms Undergoing ChemotherapyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Guido Berlucchi
- Responsible party
- Principal investigator, Marco Scarpa, Istituto Oncologico Veneto IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075580
- Sponsor's protocol ID
- BI-PORT
- Acronym
- BI-PORT
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2014
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pinto E, Granziera E, Cagol M, Cappellato S, Alfieri R, Mari V, Meroni M, Zagonel V, Conte P, Pilati P, Castoro C, Cavallin F, Scarpa M. Totally Implantable Venous Access Devices: A Randomized Controlled Trial on the Effect of Psychological Support on Quality of Life and Body Image (BI-PORT). Front Psychol. 2021 Nov 12;12:703497. doi: 10.3389/fpsyg.2021.703497. eCollection 2021.
PubMed 34867586
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Totally Implantable Venous Access Devices (TIVAD): Impact on Quality of Life and Body Image
- ClinicalTrials.gov ID
- NCT02075580
- Acronym / sponsor ID
- BI-PORT / BI-PORT
- Conditions
- Neoplasms Undergoing Chemotherapy
- Keywords
- cancer, quality of life, body-image, subcutaneous-implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Collaborators
- Fondazione Guido Berlucchi
- Study start
- Sep 2013
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Mar 2014 (estimated)
- 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.
Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients modify body image and self-representation. Therefore, the purpose of this study is to evaluate the efficacy of psychological intervention on patients undergone this surgical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychological support | Experimental | Behavioral: psychological support (interactive/cognitive strategies)Arm A will undergo psychological support and standard care prior and post TIVAD (Totally Implantable Venous Access Devices) insertion Arm B will undergo standard care prior and post TIVAD insertion |
| standard care | No intervention | –this arm does not receive psychological support before and after Totally Implantable Venous Access Devices positioning |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- neoplastic patients
- adults
- not visible demolitive interventions
- not psychopathological diagnosis
- language understanding
Key exclusion criteria (3 listed)
- not neoplastic patients
- psychopathological diagnosis
- language misunderstanding
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 |
|---|---|---|
| psychological support (interactive/cognitive strategies)* cognitive/behavioural intervention (6 times starting from hospital admission, in 90 days; for arm of intervention) * metacognitive techniques (6 times starting from hospital admission, in 90 days; for arm of intervention) * psychoeducational intervention (6 times starting from hospital admission; for arm of intervention) * questionnaires: EORTC questionnaires and a written structured interview (3 times: hospital admission,15 days after surgical intervention, 90 days after intervention; in both arms) | Behavioural | psychological support |
Primary outcome
Generic and quality of life and body image
Time frame: 15 days
EORTC (European Organization for Research and Treatment of Cancer) questionnaire: BR23 (Breast questionnaire, used just for BI scale, that is Body Image items)
1 secondary outcome
Satisfaction with care
Time frame: 15 days
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 27 Feb 2019.
- Derived from this study: PubMed 34867586Pinto E, Granziera E, Cagol M, Cappellato S, Alfieri R, Mari V, Meroni M, Zagonel V, Conte P, Pilati P, Castoro C, Cavallin F, Scarpa M. Totally Implantable Venous Access Devices: A Randomized Controlled Trial on the Effect of Psychological Support on Quality of Life and Body Image (BI-PORT). Front Psychol. 2021 Nov 12;12:703497. doi: 10.3389/fpsyg.2021.703497. eCollection 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychological support (interactive/cognitive strategies) in people with Neoplasms Undergoing Chemotherapy, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
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 5 inclusion and 3 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 27 Feb 2019. 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 Italy. 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?
Generic and quality of life and body image (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02075580, which also lists 1 linked publication.
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 27 Feb 2019.