Gastro-intestinal CancerNCT02038114
The Impact of a Patient Education Intervention for Ambulatory Oncology Patients
A study testing Instructed to read patient education pamphlets in people with Gastro-intestinal Cancer and Lung Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This study will test the impact of newly created and available symptom management patient education brochures on symptom burden [measured via the Edmonton Symptom Assessment System (ESAS)], health-related quality of life [measured by the European Organisation for Research and Treatment of Cancer Quality of Life… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-intestinal Cancer, Lung Cancer, Head and Neck Cancer
- What is being tested?
- Instructed to read patient education pamphlets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Jun 2014
- 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
- receiving treatment at the Odette Cancer Centre or Breast Cancer Centre at Sunnybrook Hospital
- over the age of 18
- English-speaking and able to read and complete a survey in English
- Exclusion Criteria (patients will be withdrawn from study in the event that...):
- The patient is thought to be at risk to self or others, or be in need of immediate psychiatric assessment, in which case the patient will be referred urgently for assessment with psychosocial oncology or department of psychiatry
- The patient wishes to discontinue the study
- The patient is noted to be cognitively impaired during the course of the study such that he cannot complete a questionnaire reliably or physically impaired such that it is too burdensome
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Patient Education Intervention on Knowledge, Self-efficacy, Symptom Burden, Health Related Quality of Life and Satisfaction With the Experience of Care for Oncology Ambulatory Patients Post Completion of the Edmonton Screening Assessment System
This study will test the impact of newly created and available symptom management patient education brochures on symptom burden [measured via the Edmonton Symptom Assessment System (ESAS)], health-related quality of life [measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)], patient satisfaction with care [measured by the Princess Margaret Hospital Patient Satisfaction Questionnaire (PMH/PSQ-MD 29) and the European Organisation for Research and Treatment of Cancer Patient Satisfaction with Radiation or Chemotherapy (EORTC PatSat35 RT/CT)], self-efficacy, and knowledge at Sunnybrook Health Sciences Centre in Toronto, Canada. These brochures are designed for oncology patients in order to provide a response to symptom screening and are now a standard part of care. Symptom screening occurs at each visit as patients are required to fill out ESAS, that asks about their experience with the occurence and severity of symptoms. The intent of the patient brochures are to acknowledge the screen, validate the symptom and provide knowledge of self-management strategies for symptoms. The brochures also provide information to patients about when and how to seek further help from their oncology team. The hope is that patients will experience a useful response to their screen with all levels of symptoms-from 0-10 in severity
It is hypothesized that the addition of patient education symptom management pamphlets on 7 of the symptoms measured by ESAS (appetite, nausea and vomiting, depression, anxiety, fatigue, dyspnea and pain) will provide new and meaningful information which will build knowledge, validate the patient's experience of the symptom, lead to increased satisfaction with care, improved self efficacy in managing and accessing help for the symptom and therefore improved health related quality of life.
- Being tested
- Instructed to read patient education pamphlets
- Keywords
- Odette Cancer Centre at Sunnybrook Health Sciences Centre, Toronto, Ontario
- Medical subject headings
- Lung Neoplasms, Head and Neck Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructed to read patient education pamphletsBehavioural
The intervention in this study is the administration of patient education pamphlets and instructions to read them. Half of all patients who participate in this study will be required to read pamphlets on symptoms that are relevant to them (i.e. symptoms that they are experiencing). Subsequent to reading pamphlets, patients will complete study questionnaires to assess their impact.
| Study group | Role | What they receive |
|---|---|---|
| Instructed to read pamphlets | Experimental | This group will be instructed to read patient education pamphlets. Receives: Behavioral: Instructed to read patient education pamphlets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Patient Pamphlets on knowledge
Participants who are asked to read patient education pamphlets on symptoms will complete our survey subsequent to reading which test their knowledge about pamphlets. We will be about to conclude later whether reading the pamphlets was correlated with greater knowledge when compared to the control group who did not read the pamphlets.
Measured: approx. 6 months for data collection
Secondary outcomes (1)
Impact of patient education pamphlets on health-related quality of life (HRQoL)
This study will also assess whether the intervention group (that read the pamphlets) differed from the control group (who did not read the pamphlets) in terms of health-related quality of life.
Measured: approx. 6 months for data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-intestinal CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara Harth, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038114
- Sponsor's protocol ID
- 340-2011
- Status last verified
- Sep 2014
- First submitted
- 25 Nov 2013
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Patient Education Intervention on Knowledge, Self-efficacy, Symptom Burden, Health Related Quality of Life and Satisfaction With the Experience of Care for Oncology Ambulatory Patients Post Completion of the Edmonton Screening Assessment System
- ClinicalTrials.gov ID
- NCT02038114
- Acronym / sponsor ID
- 340-2011
- Keywords
- Odette Cancer Centre at Sunnybrook Health Sciences Centre, Toronto, Ontario
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Jan 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 will test the impact of newly created and available symptom management patient education brochures on symptom burden [measured via the Edmonton Symptom Assessment System (ESAS)], health-related quality of life [measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)], patient satisfaction with care [measured by the Princess Margaret Hospital Patient Satisfaction Questionnaire (PMH/PSQ-MD 29) and the European Organisation for Research and Treatment of Cancer Patient Satisfaction with Radiation or Chemotherapy (EORTC PatSat35 RT/CT)], self-efficacy, and knowledge at Sunnybrook Health Sciences Centre in Toronto, Canada. These brochures are designed for oncology patients in order to provide a response to symptom screening and are now a standard part of care. Symptom screening occurs at each visit as patients are required to fill out ESAS, that asks about their experience with the occurence and severity of symptoms. The intent of the patient brochures are to acknowledge the screen, validate the symptom and provide knowledge of self-management strategies for symptoms. The brochures also provide information to patients about when and how to seek further help from their oncology team. The hope is that patients will experience a useful response to their screen with all levels of symptoms-from 0-10 in severity
It is hypothesized that the addition of patient education symptom management pamphlets on 7 of the symptoms measured by ESAS (appetite, nausea and vomiting, depression, anxiety, fatigue, dyspnea and pain) will provide new and meaningful information which will build knowledge, validate the patient's experience of the symptom, lead to increased satisfaction with care, improved self efficacy in managing and accessing help for the symptom and therefore improved health related quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Instructed to read pamphlets | Experimental | Behavioral: Instructed to read patient education pamphletsThis group will be instructed to read patient education pamphlets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- receiving treatment at the Odette Cancer Centre or Breast Cancer Centre at Sunnybrook Hospital
- over the age of 18
- English-speaking and able to read and complete a survey in English
- The patient is thought to be at risk to self or others, or be in need of immediate psychiatric assessment, in which case the patient will be referred urgently for assessment with psychosocial oncology or department of psychiatry
- The patient wishes to discontinue the study
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instructed to read patient education pamphletsThe intervention in this study is the administration of patient education pamphlets and instructions to read them. Half of all patients who participate in this study will be required to read pamphlets on symptoms that are relevant to them (i.e. symptoms that they are experiencing). Subsequent to reading pamphlets, patients will complete study questionnaires to assess their impact. | Behavioural | Instructed to read pamphlets |
Primary outcome
Impact of Patient Pamphlets on knowledge
Time frame: approx. 6 months for data collection
Participants who are asked to read patient education pamphlets on symptoms will complete our survey subsequent to reading which test their knowledge about pamphlets. We will be about to conclude later whether reading the pamphlets was correlated with greater knowledge when compared to the control group who did not read the pamphlets.
1 secondary outcome
Impact of patient education pamphlets on health-related quality of life (HRQoL)
Time frame: approx. 6 months for data collection
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 8 Sep 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.
Tamara Harth principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructed to read patient education pamphlets in people with Gastro-intestinal Cancer and Lung Cancer, run by Sunnybrook Health Sciences Centre 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 7 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 8 Sep 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 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?
Impact of Patient Pamphlets on knowledge (time frame: approx. 6 months for data collection). 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 8 Sep 2014.