CancerNCT02298972
Symptom Support During Chemotherapy: A Mixed Method Study in Adult Patients With Cancer
A study testing Nurse support and selfmanagement intervention in people with Cancer and Chemotherapy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This study evaluates the value of a nursing symptom support en selfmanagement intervention for adult patients with cancer treated with chemotherapy. Using a prospective sequential design with a comparison group who receives standard care and a (later) intervention group who gets the nursing intervention, we will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapy
- What is being tested?
- Nurse support and selfmanagement intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Sep 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients starting first line treatment with (intravenous) chemotherapy
- Ambulatory patients or patients who receive their treatment during short hospital stays
- Regardless of type of cancer, treatment or treatment intention (curative or palliative)
- Who understand sufficiently Dutch to fill out questionnaires
- Who sign informed consent for their participation in the study
Who cannot join
- Oral anticancer treatment
- Concomitant chemoradiotherapy
- Breast cancer patients who receive nurse counseling throughout their therapy
- Experimental therapy in the context of a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the value of a nursing symptom support en selfmanagement intervention for adult patients with cancer treated with chemotherapy. Using a prospective sequential design with a comparison group who receives standard care and a (later) intervention group who gets the nursing intervention, we will evaluate the effect of this nursing intervention on overall symptom distress (primary outcome) and other measures of symptom burden, self-efficacy, outcome expectations and self-care. By conducting sem-structured interviews with some participants of the intervention group, we will study the patient experience of the intervention.
- Conditions
- Cancer, Chemotherapy
- Being tested
- Nurse support and selfmanagement intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse support and selfmanagement interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Comparison group | No intervention | The comparison group will receive standard care. |
| Intervention group | Active comparator | After completion of the comparison group, new patients starting chemotherapy treatment will be offered this study. Study participants will receive the nurse support and selfmanagement intervention. Receives: Behavioral: Nurse support and selfmanagement intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall symptom distress
Summed symptom distress as self-reported on the Symptom Burden Questionnaire
Measured: Longitudinal, during first 3 months after start of treatment
Overall symptom severity
Summed symptom severity as self-reported on the Symptom Burden Questionnaire
Measured: Longitudinal, during first 3 months after start of treatment
Secondary outcomes (3)
Total self-efficacy score
Outcome will be measured by a self-report questionnaire: shortened version of the Cancer Behavior Inventory
Measured: Day 43 of treatment (+/- 1 week)
Total outcome expectations score
Outcome will be measured by a self-report questionnaire
Measured: Day 43 of treatment (+/- 1 week)
Total self-care score
Outcome will be measured by a self-report questionnaire: shortened version of the Leuven- Patient Self-care during chemotherapy scale
Measured: Day 85 of treatment (+/- 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionSep 2015
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish League Against Cancer
- Responsible party
- Principal investigator, Annemarie Coolbrandt, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298972
- Sponsor's protocol ID
- B322201422086
- Status last verified
- Oct 2016
- First submitted
- 17 Nov 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Support During Chemotherapy: A Mixed Method Study in Adult Patients With Cancer
- ClinicalTrials.gov ID
- NCT02298972
- Acronym / sponsor ID
- B322201422086
- Conditions
- Cancer, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Flemish League Against Cancer
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Nov 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.
This study evaluates the value of a nursing symptom support en selfmanagement intervention for adult patients with cancer treated with chemotherapy. Using a prospective sequential design with a comparison group who receives standard care and a (later) intervention group who gets the nursing intervention, we will evaluate the effect of this nursing intervention on overall symptom distress (primary outcome) and other measures of symptom burden, self-efficacy, outcome expectations and self-care. By conducting sem-structured interviews with some participants of the intervention group, we will study the patient experience of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison group | No intervention | –The comparison group will receive standard care. |
| Intervention group | Active comparator | Behavioral: Nurse support and selfmanagement interventionAfter completion of the comparison group, new patients starting chemotherapy treatment will be offered this study. Study participants will receive the nurse support and selfmanagement intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients starting first line treatment with (intravenous) chemotherapy
- Ambulatory patients or patients who receive their treatment during short hospital stays
- Regardless of type of cancer, treatment or treatment intention (curative or palliative)
- Who understand sufficiently Dutch to fill out questionnaires
- Who sign informed consent for their participation in the study
Key exclusion criteria (4 listed)
- Oral anticancer treatment
- Concomitant chemoradiotherapy
- Breast cancer patients who receive nurse counseling throughout their therapy
- Experimental therapy in the context of a 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 |
|---|---|---|
| Nurse support and selfmanagement intervention | Behavioural | Intervention group |
Primary outcome
Overall symptom distress
Time frame: Longitudinal, during first 3 months after start of treatment
Summed symptom distress as self-reported on the Symptom Burden Questionnaire
Overall symptom severity
Time frame: Longitudinal, during first 3 months after start of treatment
Summed symptom severity as self-reported on the Symptom Burden Questionnaire
3 secondary outcomes
Total self-efficacy score
Time frame: Day 43 of treatment (+/- 1 week)
Total outcome expectations score
Time frame: Day 43 of treatment (+/- 1 week)
Total self-care score
Time frame: Day 85 of treatment (+/- 1 week)
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 26 Oct 2016.
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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 Nurse support and selfmanagement intervention in people with Cancer and 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 5 inclusion and 4 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 26 Oct 2016. 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?
Overall symptom distress (time frame: Longitudinal, during first 3 months after start of treatment). The study lists 2 primary outcomes in all. 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 26 Oct 2016.