Acute Lymphoblastic LeukemiaNCT01148927
Quality of Life Study for Adult Patients With Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Acute lymphoblastic leukemia (ALL) accounts for about 20% of adult leukemias. Treatment results in adult ALL have lagged behind the improvements achieved in the pediatric population. A modified version of the Dana Farber Cancer Institute pediatric protocol is used to treat adult patients with ALL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Oct 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Long-term survivors of adult acute lymphoblastic leukemia treated with modified Dana Farber Cancer Institute ALL protocol (91-01).
Who may be able to join
- previously diagnosed with adult ALL or T-lymphoblastic lymphoma
- Age >/= 18
- Have completed the two-year modified DFCI protocol at least three months earlier and are in continuous complete remission
- Understand English and are able to fill out questionnaires
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Quality of Life of Long Term Survivors of Adult Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) accounts for about 20% of adult leukemias. Treatment results in adult ALL have lagged behind the improvements achieved in the pediatric population. A modified version of the Dana Farber Cancer Institute pediatric protocol is used to treat adult patients with ALL. The results seem to be superior to those reported with other adult protocols. However, there is limited data on the impact of such intensified approaches and resulting toxicities on the quality of life (QOL) of these survivors. Identifying important factors affecting the QOL may permit attempts at early interventions and may help to further modify the regimen and mitigate these adverse effects on QOL.
This study is evaluating the quality of life of long term survivors of adult ALL. It involves the patients filling out several questionnaires that are well-validated measures assessing various QOL issues of concern to these patients. The following questionnaires are used in this study:
Read more
- EORTC QLQ C30 to assess global health and major health domains
- Brief Pain Inventory (BPI)
- Personal Health Questionnaire (PHQ9) to assess psychosocial distress
- Functional Assessment of Cancer Therapy (FACT) Fatigue Questionnaire
- Peripheral Neuropathy Questionnaire
The data obtained from the questionnaires will be analyzed and the various domains of health will be quantified.
- Conditions
- Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult acute lymphoblastic leukemia patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the quality of life of the long-term survivors of adult acute lymphoblastic leukemia treated uniformly with the modified Dana Farber Cancer Institute ALL protocol (91-01)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph M Brandwein, MD, FRCPC, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148927
- Sponsor's protocol ID
- 09-0619-CE
- Status last verified
- Jan 2013
- First submitted
- 21 Jun 2010
- Last updated
- 11 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Quality of Life of Long Term Survivors of Adult Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT01148927
- Acronym / sponsor ID
- 09-0619-CE
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Jun 2010 (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.
Acute lymphoblastic leukemia (ALL) accounts for about 20% of adult leukemias. Treatment results in adult ALL have lagged behind the improvements achieved in the pediatric population. A modified version of the Dana Farber Cancer Institute pediatric protocol is used to treat adult patients with ALL. The results seem to be superior to those reported with other adult protocols. However, there is limited data on the impact of such intensified approaches and resulting toxicities on the quality of life (QOL) of these survivors. Identifying important factors affecting the QOL may permit attempts at early interventions and may help to further modify the regimen and mitigate these adverse effects on QOL.
This study is evaluating the quality of life of long term survivors of adult ALL. It involves the patients filling out several questionnaires that are well-validated measures assessing various QOL issues of concern to these patients. The following questionnaires are used in this study:
- EORTC QLQ C30 to assess global health and major health domains
- Brief Pain Inventory (BPI)
- Personal Health Questionnaire (PHQ9) to assess psychosocial distress
- Functional Assessment of Cancer Therapy (FACT) Fatigue Questionnaire
- Peripheral Neuropathy Questionnaire
The data obtained from the questionnaires will be analyzed and the various domains of health will be quantified.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult acute lymphoblastic leukemia patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Long-term survivors of adult acute lymphoblastic leukemia treated with modified Dana Farber Cancer Institute ALL protocol (91-01).
Key inclusion criteria (4 listed)
- previously diagnosed with adult ALL or T-lymphoblastic lymphoma
- Age >/= 18
- Have completed the two-year modified DFCI protocol at least three months earlier and are in continuous complete remission
- Understand English and are able to fill out questionnaires
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the quality of life of the long-term survivors of adult acute lymphoblastic leukemia treated uniformly with the modified Dana Farber Cancer Institute ALL protocol (91-01)
Time frame: 9 months
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 11 Jan 2013.
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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.
Joseph M Brandwein, MD, FRCPC principal investigator
Princess Margaret Hospital, Canada
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 Acute Lymphoblastic Leukemia, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 0 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 11 Jan 2013. 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 Canada. 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?
To evaluate the quality of life of the long-term survivors of adult acute lymphoblastic leukemia treated uniformly with the modified Dana Farber Cancer Institute ALL protocol (91-01) (time frame: 9 months). 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 11 Jan 2013.