CancerNCT02660996
Effectiveness of the Advocate Lutheran General Survivorship Center Programs
An observational study of Cancer and Quality of Life, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The objective of this observational study is to assess the effectiveness of the Advocate Lutheran General Survivorship Center's Programs by measuring the following outcomes of interest on participating patients: 1. Quality of life 2. Distress level 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Quality of Life
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 14 Aug 2017
- 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: Newly diagnosed cancer patients who see one of the oncologists at The Advocate Lutheran General Hospital Center of for Advanced Care. Patients who older than 18 years of age, male or female, and any race are eligible. Patients who are new to the Survivorship Center or only visited once are eligible.
Who may be able to join
- Patients older than 18 years of age, any gender, and any race
- Newly diagnosed with any type of cancer and now seeing one of the oncologists at the Advocate Lutheran General Hospital's Center for Advanced Care
- Patients new to the Survivorship Center or only visited once
- Must attend at least four classes in a two month period (any class, any time, any day)
- Able to consent
- English speaking patient
Who cannot join
- Not a newly diagnosed cancer patient
- Patients under the age of 18
- Pregnant patients
- Prisoners
- Unable to consent
- Non - English speaking patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
Official title: Assessing the Effectiveness of the Advocate Lutheran General Survivorship Center Programs on Patients' Quality of Life, Distress Level, and Satisfaction
The objective of this observational study is to assess the effectiveness of the Advocate Lutheran General Survivorship Center's Programs by measuring the following outcomes of interest on participating patients:
- Quality of life
- Distress level
- Satisfaction with the Survivorship Program
General Hypothesis: Patients who participate in at least four classes in a two month period will have higher scores on the post-class satisfaction, quality of life, and distress surveys compared to their pre-class surveys.
Read the detailed description
- If a patient agrees to participate, written consent will be obtained by the study coordinators. Before the start of the first class at the Survivorship Center and after the patients have signed the consent and HIPAA authorization forms, patients will fill out three questionnaires. These include the standardized RAND 36 Health Survey, the Distress Thermometer, and a pilot survey regarding expectations and satisfaction with the Survivorship Program.
- The RAND-36 survey is a form that includes 36 questions and asks how patients feel their illness has impacted them and their lifestyle with scoring as noted. Pre-coded numeric values are recoded per the scoring key. They are scored so that a high score means patient is in better health, 0 being the worst and 10 being the best. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Missing data is not taken into account. The RAND 36-Item Health Survey 1.0 has been validated in previous studies. According to the VanderZee's study (1996), it was shown that the "internal consistency of the instrument was high with high convergent validity."
- The Distress Thermometer (DT) tool asks patients 39 questions about practical, family, emotional, religious, and physical problems in a "yes" or "no" format. A "yes" will scored as 0 and a "no" will be scored as 1. Therefore, the lower the stress level, the higher the score. The scores will be added for a total score. If the patient does show a high level of distress with a score above 12 on the Distress Thermometer after the four classes at the Survivorship Center, we will refer the patient back to his or her physician for further guidance and possible counseling.
- The Expectation Survey consists of eight questions that ask patients about their expectations for what they want/hope to get out of the Survivorship Program. Patients will rank their answers from 1 - 5 based on how much they agree with the statement (1 being not at all, 5 being very much). The scores for each eight questions will then be averaged.
- The Satisfaction Survey is also an eight question form that is much like the Expectation Survey. Patients will also indicate how satisfied with they are with the classes/courses at the Survivorship Center. The same scaling as above (1-5; 1 being not all agreeing with the statement and 5 being very much) with be used. These two surveys will be pilot tested for content relevance and readability level with current patients. Editions will be made as necessary. There will also be an open ended question at the end to ask patients what they would add to the classes to make them more beneficial.
- Participants will be asked to complete the Rand-36 SF, Distress Thermometer, and Satisfaction Survey after attending at least four Survivorship classes in a two month period.
- Conditions
- Cancer, Quality of Life
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Questionnaire that includes 36 questions and asks how patients feel their illness has impacted them and their lifestyle with scoring as noted.
Measured: 6-8 months
Secondary outcomes (2)
Distress level
The tool asks patients 39 questions about practical, family, emotional, religious, and physical problems in a "yes" or "no" format. A "yes" will scored as 0 and a "no" will be scored as 1. Therefore, the lower the stress level, the higher the score. The scores will be added for a total score.
Measured: 6-8 months
Satisfaction with the Survivorship Program
Questionnaire that includes 8 questions that indicate how satisfied the patients are with the classes offered at the Survivorship Center.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study start1 Oct 2016
- Primary completion31 Mar 2017
- Study completion14 Aug 2017
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 Wake Forest University Health SciencesThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sigrun Hallmeyer, MD, Principal investigator, Advocate Lutheran General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660996
- Sponsor's protocol ID
- 5857
- Status last verified
- Jul 2019
- First submitted
- 14 Jan 2016
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Conference presentation and publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of the Advocate Lutheran General Survivorship Center Programs on Patients' Quality of Life, Distress Level, and Satisfaction
- ClinicalTrials.gov ID
- NCT02660996
- Acronym / sponsor ID
- 5857
- Conditions
- Cancer, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 21 Jan 2016 (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 objective of this observational study is to assess the effectiveness of the Advocate Lutheran General Survivorship Center's Programs by measuring the following outcomes of interest on participating patients:
- Quality of life
- Distress level
- Satisfaction with the Survivorship Program
General Hypothesis: Patients who participate in at least four classes in a two month period will have higher scores on the post-class satisfaction, quality of life, and distress surveys compared to their pre-class surveys.
Detailed description
- If a patient agrees to participate, written consent will be obtained by the study coordinators. Before the start of the first class at the Survivorship Center and after the patients have signed the consent and HIPAA authorization forms, patients will fill out three questionnaires. These include the standardized RAND 36 Health Survey, the Distress Thermometer, and a pilot survey regarding expectations and satisfaction with the Survivorship Program.
- The RAND-36 survey is a form that includes 36 questions and asks how patients feel their illness has impacted them and their lifestyle with scoring as noted. Pre-coded numeric values are recoded per the scoring key. They are scored so that a high score means patient is in better health, 0 being the worst and 10 being the best. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Missing data is not taken into account. The RAND 36-Item Health Survey 1.0 has been validated in previous studies. According to the VanderZee's study (1996), it was shown that the "internal consistency of the instrument was high with high convergent validity."
- The Distress Thermometer (DT) tool asks patients 39 questions about practical, family, emotional, religious, and physical problems in a "yes" or "no" format. A "yes" will scored as 0 and a "no" will be scored as 1. Therefore, the lower the stress level, the higher the score. The scores will be added for a total score. If the patient does show a high level of distress with a score above 12 on the Distress Thermometer after the four classes at the Survivorship Center, we will refer the patient back to his or her physician for further guidance and possible counseling.
- The Expectation Survey consists of eight questions that ask patients about their expectations for what they want/hope to get out of the Survivorship Program. Patients will rank their answers from 1 - 5 based on how much they agree with the statement (1 being not at all, 5 being very much). The scores for each eight questions will then be averaged.
- The Satisfaction Survey is also an eight question form that is much like the Expectation Survey. Patients will also indicate how satisfied with they are with the classes/courses at the Survivorship Center. The same scaling as above (1-5; 1 being not all agreeing with the statement and 5 being very much) with be used. These two surveys will be pilot tested for content relevance and readability level with current patients. Editions will be made as necessary. There will also be an open ended question at the end to ask patients what they would add to the classes to make them more beneficial.
- Participants will be asked to complete the Rand-36 SF, Distress Thermometer, and Satisfaction Survey after attending at least four Survivorship classes in a two month period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed cancer patients who see one of the oncologists at The Advocate Lutheran General Hospital Center of for Advanced Care. Patients who older than 18 years of age, male or female, and any race are eligible. Patients who are new to the Survivorship Center or only visited once are eligible.
Key inclusion criteria (6 listed)
Key exclusion criteria (6 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
Quality of life
Time frame: 6-8 months
Questionnaire that includes 36 questions and asks how patients feel their illness has impacted them and their lifestyle with scoring as noted.
2 secondary outcomes
Distress level
Time frame: 6-8 months
Satisfaction with the Survivorship Program
Time frame: 6-8 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 4 Oct 2024.
- Individual participant dataSharing planned: Yes. Conference presentation and publication
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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.
Sigrun Hallmeyer, MD principal investigator
Advocate Lutheran General Hospital
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 Cancer and Quality of Life, run by Wake Forest University Health Sciences at 1 site in United States.
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 6 inclusion and 6 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 4 Oct 2024. 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 United States. 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?
Quality of life (time frame: 6-8 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 4 Oct 2024.