Exploration of How Patients Deal With Side Effects From ChemotherapyNCT01867489
A Qualitative Study Into How Patients Deal With Chemotherapy-related Side Effects at Home
An observational study of Exploration of How Patients Deal With Side Effects From Chemotherapy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This qualitative study explores how patients deal with the side effects from chemotherapy at their home, what factors and ideas influence their symptom self-management and how professional caregivers contribute to the management of their symptoms at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exploration of How Patients Deal With Side Effects From Chemotherapy
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2012to Jan 2014
- 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: Adult patients treated with chemotherapy
Who may be able to join
- Adult (≥18 years) patients with (any type and any stage of) cancer who were undergoing chemotherapy treatment in an ambulatory setting or during short hospital stays
- Dutch speaking
- Able to provide informed consent and to participate in an interview
Who cannot join
- Patients who were in the first 2 cycles of treatment
- Patients for whom an interview was considered physically, mentally and/or emotionally too burdensome.
- Patients who had reported not to experience any side effect from treatment at all
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Qualitative Study Into How Patients With Cancer Deal With Chemotherapy-Related Side Effects at Home
This qualitative study explores how patients deal with the side effects from chemotherapy at their home, what factors and ideas influence their symptom self-management and how professional caregivers contribute to the management of their symptoms at home. Data are collected through semi-structured interviews with adult patients treated with chemotherapy and analysed using a Grounded Theory approach.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy, Cancer | Adult cancer patients (with any type of cancer) being treated with chemotherapy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient's experience
Measured: one interview during the course of treatment, i.e. one timepoint between 2 months after the start of chemotherapy and the end of the patient's treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exploration of How Patients Deal With Side Effects From ChemotherapyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annemarie Coolbrandt, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867489
- Sponsor's protocol ID
- B322201214929
- Status last verified
- Nov 2014
- First submitted
- 19 May 2013
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study Into How Patients With Cancer Deal With Chemotherapy-Related Side Effects at Home
- ClinicalTrials.gov ID
- NCT01867489
- Acronym / sponsor ID
- B322201214929
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 4 Jun 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.
This qualitative study explores how patients deal with the side effects from chemotherapy at their home, what factors and ideas influence their symptom self-management and how professional caregivers contribute to the management of their symptoms at home. Data are collected through semi-structured interviews with adult patients treated with chemotherapy and analysed using a Grounded Theory approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy, Cancer | – | Other: No interventionAdult cancer patients (with any type of cancer) being treated with chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated with chemotherapy
Key inclusion criteria (3 listed)
- Adult (≥18 years) patients with (any type and any stage of) cancer who were undergoing chemotherapy treatment in an ambulatory setting or during short hospital stays
- Dutch speaking
- Able to provide informed consent and to participate in an interview
Key exclusion criteria (3 listed)
- Patients who were in the first 2 cycles of treatment
- Patients for whom an interview was considered physically, mentally and/or emotionally too burdensome.
- Patients who had reported not to experience any side effect from treatment at all
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 |
|---|---|---|
| No intervention | Other | Chemotherapy, Cancer |
Primary outcome
patient's experience
Time frame: one interview during the course of treatment, i.e. one timepoint between 2 months after the start of chemotherapy and the end of the patient's treatment
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 18 Nov 2014.
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?
An observational study of Exploration of How Patients Deal With Side Effects From Chemotherapy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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 18 Nov 2014. 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 Belgium. 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?
patient's experience (time frame: one interview during the course of treatment, i.e. one timepoint between 2 months after the start of chemotherapy and the end of the patient's treatment). 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 18 Nov 2014.