CancerPhase 4PAINCT01949974

Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients

A Phase 4 study testing Standard Palliative Chemotherapy and Integral Attention Program (PAI) in people with Cancer, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 3 sites in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this clinical trial is to compare a non-pharmaceutical intervention (Integral Attention Program or PAI) versus standard palliative chemotherapy treatment plus PAI in patients with advanced cancer who have already received at least a first course of chemotherapy but had proven therapeutic failure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
What is being tested?: Standard Palliative Chemotherapy and Integral Attention Program (PAI)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 3 sitesSpain
Study dates: Jun 2013to Jun 2016
Phase: Phase 4
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women ≥18 years of age.
Patients potentially eligible to receive a new chemotherapy cycle and whose clinical condition, according to the oncologist, does not identify any therapeutic strategy clearly superior to another, in the light of scientific evidence.
Patients with advanced cancers that have been treated with chemotherapy but who have not displayed complete response to treatment or who, after treatment response, are now in a situation of recurrence or disease progression
Patients who have previously received at least one chemotherapy cycle of the following tumors:
Cancer of the digestive and gastrointestinal tract
Head and Neck Cancer

Show all 13Show fewer

Lung cancer
Urologic cancers
Gynecologic cancers
Central nervous system cancer
Melanoma
Patients who can potentially comply with study and/or monitoring procedures and to accept and sign the informed consent form.
Patients whose home is located less than 10 km, approximately, of the hospitals participating in the study.

Who cannot join

Patients who are currently receiving chemotherapy, although patient pursuing any other concomitant treatment are eligible (eg, hormone therapy or radiation therapy).
Patients who have contraindications to chemotherapy.
Patients who did not agree to participate in the clinical trial

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital General de l'Hospitalet de Llobregat
L'Hospitalet de Llobregat, Barcelona, 08906
Corporació Sanitària Parc Taulí
Sabadell, Barcelona

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About this study

Official title: Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients: A Randomized Multicenter Clinical Trial

The study hypothesis is that palliative chemotherapy offers no clear benefits in relation to quality-of-life-adjusted survival compared to a comprehensive care program.

Conditions: Cancer
Being tested: Standard Palliative Chemotherapy, Integral Attention Program (PAI)
Keywords: Palliative Chemotherapy, Integral Attention Program, Advanced cancer, Randomized Clinical Trial
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard Palliative ChemotherapyDrug
Standard Palliative Chemotherapy, depending on type cancer.
Integral Attention Program (PAI)Other
The PAI is a plan of care and treatment adapted in accordance with the evolution and needs of patients. This plan includes an initial comprehensive assessment of patients and their families during the first visit, including specialized psychological and social support when needed, voluntary art therapy and/or mindfulness. There will be outpatient monitoring, 24h phone assistance, home visits, support should hospitalization be required, and unscheduled visits by a palliative care team.

Study groups in NCT01949974
Study group	Role	What they receive
Integral Attention Program (PAI)	Experimental	The key points of the PAI are: * To assess and manage pain and other symptoms resulting from disease progression. * To evaluate the information needs that may arise and to address them. * To encourage patient and family adaptation to the situation of advanced disease and in the terminal phase of it. * To provide guidance in decision-making while respecting patient autonomy. * To establish a plan of care and treatment, adapted to the evolution and needs of the patient. * To promote continuity of care. Receives: Other: Integral Attention Program (PAI)
Standard Palliative Chemotherapy and PAI	Active comparator	Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above. Receives: Drug: Standard Palliative Chemotherapy; Other: Integral Attention Program (PAI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Survival adjusted for quality of life
Quality of life will be measured by the EuroQoL-5D questionnaire.
Measured: At one year of follow-up

Secondary outcomes (6)

Specific Quality of life: measured through the quality of life questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ C-30) and Palliative Care Scale (POS)
Measured: At one year of follow-up
Control of symptoms using the Edmonton Symptom Assessment System
Measured: At one year of follow-up
Toxicity by the American National Cancer Institute toxicity
Measured: At one year of follow-up
Patient satisfaction regarding care using a Likert scale of 5 items (very satisfied, satisfied, neither satisfied or dissatisfied, somewhat satisfied and not satisfied).
Measured: At one year of follow-up
Costs reported by the information system of each hospital
Measured: At the end of follow-up
Adverse effects related to study interventions
Measured: At one year of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jun 2016

First posted25 Sep 2013 (estimated)
Study startJun 2013
Primary completionJun 2014 (estimated)
Study completionJun 2016 (estimated)

Why it stopped: Dificulties in the recruitment of patients.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CancerStudies 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 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01949974
Sponsor's protocol ID: IIBSP-PAI-2011-36
Other IDs: 2012-001128-36, PI11/01366
Acronym: PAI
Status last verified: Aug 2013
First submitted: 17 Sep 2013
Last updated: 28 May 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients: A Randomized Multicenter Clinical Trial
ClinicalTrials.gov ID: NCT01949974
Acronym / sponsor ID: PAI / IIBSP-PAI-2011-36
Conditions: Cancer
Keywords: Palliative Chemotherapy, Integral Attention Program, Advanced cancer, Randomized Clinical Trial
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Dificulties in the recruitment of patients.
Enrolment: 0 participants (actual)
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
Study start: Jun 2013
Primary completion: Jun 2014 (estimated)
Study completion: Jun 2016 (estimated)
First posted: 25 Sep 2013 (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.

The study hypothesis is that palliative chemotherapy offers no clear benefits in relation to quality-of-life-adjusted survival compared to a comprehensive care program.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Integral Attention Program (PAI)	Experimental	Other: Integral Attention Program (PAI)The key points of the PAI are: * To assess and manage pain and other symptoms resulting from disease progression. * To evaluate the information needs that may arise and to address them. * To encourage patient and family adaptation to the situation of advanced disease and in the terminal phase of it. * To provide guidance in decision-making while respecting patient autonomy. * To establish a plan of care and treatment, adapted to the evolution and needs of the patient. * To promote continuity of care.
Standard Palliative Chemotherapy and PAI	Active comparator	Drug: Standard Palliative Chemotherapy, Other: Integral Attention Program (PAI)Standard palliative chemotherapy will be administered, depending on type of cancer, as well as PAI as been defined above.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Men and women ≥18 years of age.
Patients potentially eligible to receive a new chemotherapy cycle and whose clinical condition, according to the oncologist, does not identify any therapeutic strategy clearly superior to another, in the light of scientific evidence.
Patients with advanced cancers that have been treated with chemotherapy but who have not displayed complete response to treatment or who, after treatment response, are now in a situation of recurrence or disease progression
Patients who have previously received at least one chemotherapy cycle of the following tumors:
Patients who can potentially comply with study and/or monitoring procedures and to accept and sign the informed consent form.

Key exclusion criteria (3 listed)

Patients who are currently receiving chemotherapy, although patient pursuing any other concomitant treatment are eligible (eg, hormone therapy or radiation therapy).
Patients who have contraindications to chemotherapy.
Patients who did not agree to participate in the clinical trial

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
Standard Palliative ChemotherapyStandard Palliative Chemotherapy, depending on type cancer.	Drug	Standard Palliative Chemotherapy and PAI
Integral Attention Program (PAI)The PAI is a plan of care and treatment adapted in accordance with the evolution and needs of patients. This plan includes an initial comprehensive assessment of patients and their families during the first visit, including specialized psychological and social support when needed, voluntary art therapy and/or mindfulness. There will be outpatient monitoring, 24h phone assistance, home visits, support should hospitalization be required, and unscheduled visits by a palliative care team.	Other	Integral Attention Program (PAI), Standard Palliative Chemotherapy and PAI

Primary outcome

Survival adjusted for quality of life
Time frame: At one year of follow-up
Quality of life will be measured by the EuroQoL-5D questionnaire.

6 secondary outcomes

Specific Quality of life: measured through the quality of life questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ C-30) and Palliative Care Scale (POS)
Time frame: At one year of follow-up
Control of symptoms using the Edmonton Symptom Assessment System
Time frame: At one year of follow-up
Toxicity by the American National Cancer Institute toxicity
Time frame: At one year of follow-up
Patient satisfaction regarding care using a Likert scale of 5 items (very satisfied, satisfied, neither satisfied or dissatisfied, somewhat satisfied and not satisfied).
Time frame: At one year of follow-up
Costs reported by the information system of each hospital
Time frame: At the end of follow-up
Adverse effects related to study interventions
Time frame: At one year of follow-up

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.

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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.

Antonio Pascual, Dr., PhD principal investigator

Palliative Unit. Clinical Oncology Service. Hospital de la Santa Creu i Sant Pau. Barcelona. Spain.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 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: withdrawn, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Survival adjusted for quality of life (time frame: At one year of follow-up). 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 NCT01949974.

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 28 May 2014.