Solid TumorNCT04047589
Assessing Exercise Behavior and Preferences Among Patients and Oncologists
An observational study of Solid Tumor and Exercise, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to understand the preferences and barriers surrounding exercise of both the patients and oncologists within Indiana University Simon Cancer Center. This information will establish gaps in our current care and provide important information to guide future pilot interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Exercise
- What is being tested?
- Survey regarding exercise habits, barriers to exercise, and experience with exercise services from the cancer center. and Survey regarding personal exercise habits and beliefs, barriers to making exercise recommendations
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 28 Feb 2020
- 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: Potential patients will be identified in the outpatient clinics (women's and multi-disciplinary) at the IU Simon Cancer Center. Physicians will be given the option of requesting that their patients not participate in the survey. When patients check in or are placed in an exam room, a trained member of the clinic staff will approach patients about possible participation in the survey study. Physicians seeing patients more than once per week in the outpatient clinics at the IU Simon Cancer Center will receive email invitation to participate in the survey. An online survey will be administered via Survey Monkey. This does not require an informed consent process. The survey has 14 questions and will take approximately 5 minutes to complete.
Who may be able to join
- Physician survey Any oncologist/hematologist practicing within IUSCC regularly providing care for patients with solid tumor malignancies (seeing patients one or more days per week in the multidisciplinary or women's clinics with solid tumor malignancies). Physicians providing care only for hematologic (multiple myeloma, leukemia, lymphoma, transplant) or benign disorders will be excluded.
- Patient survey
- Patients with a current or previous diagnosis of stage 0-III or curable solid tumor
- Patients receiving any component of their medical oncologic care at IUSCC
- Age ≥ 18 years
- Able to read and write English
Who cannot join
- Metastatic disease at the time of study participation
- Inability to complete the survey
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Assessing Exercise Behavior and Preferences Among Patients and Oncologists at Indiana University Simon Cancer Center
The purpose of this study is to understand the preferences and barriers surrounding exercise of both the patients and oncologists within Indiana University Simon Cancer Center. This information will establish gaps in our current care and provide important information to guide future pilot interventions.
Read the detailed description
This descriptive, cross-sectional study will survey patients with a current or previous diagnosis of non-metastatic solid tumor malignancy who are being seen at the Indiana University Simon Cancer in Indianapolis, Indiana. Patients with active, incurable disease are excluded. Willing and eligible patients will complete a brief, 14 question survey while seen in the waiting room of the women's or multi-disciplinary clinics. We aim to survey 350 patients over a 12 month period. Patients will fill out the survey at only one point in time and no patient identifiers will be kept.
During COVID-19 restrictions, we will also send out an electronic version of the survey to participants using the email address provided in their Cerner accounts. Responses will be captured by REDCAP and will remain anonymous and not linked to the patients' medical record or personal health information.
The physician survey will be emailed to oncologist/hematologists practicing within IUSCC who see patients at least once per week. Physicians will receive a survey at only one point in time. The survey will be anonymous and no physician identifiers will be kept.
Primary objective Estimate the proportion of patients with curable solid tumor malignancies seen at the Indiana University Simon Cancer Center who are meeting exercise recommendations for cancer survivors (more than 150 minutes per week of moderate or 75 minutes per week of vigorous activity).
Secondary objectives
- Assess patients' perceived barriers to exercise during cancer survivorship
- Assess patients' preferences for receiving exercise recommendations
- Assess oncologists' perceived barriers to making exercise recommendations
- Assess oncologists' preferences for exercise and physical activity resources that could be provided by the cancer center
- Conditions
- Solid Tumor, Exercise
- Being tested
- Survey regarding exercise habits, barriers to exercise, and experience with exercise services from the cancer center., Survey regarding personal exercise habits and beliefs, barriers to making exercise recommendations
- Keywords
- solid tumor, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey regarding exercise habits, barriers to exercise, and experience with exercise services from the cancer center.Behavioural
Survey created at Indiana University to gain information regarding exercise habits, barriers to exercise, and experience with exercise services from the cancer center.
Survey regarding personal exercise habits and beliefs, barriers to making exercise recommendationsBehavioural
Survey regarding personal exercise habits and beliefs, barriers to making exercise recommendations, and potential resources the cancer center might provide to help make effective exercise recommendations in the future
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Cancer patients with curable or previously treated malignancies Receives: Behavioral: Survey regarding exercise habits, barriers to exercise, and experience with exercise services from the cancer center. | |
| Providers | Physicians seeing patients in the outpatient clinics at the IU Simon Cancer Center Receives: Behavioral: Survey regarding personal exercise habits and beliefs, barriers to making exercise recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who meet exercise recommendations.
Patients self-reporting more than 150 minutes per week of moderate physical activity OR more than 75 minutes per week of vigorous physical activity
Measured: baseline
Secondary outcomes (4)
Patient Perceived barriers to exercise during cancer survivorship via pilot survey
Investigator created survey with 14 items regarding demographics, cancer history, exercise habits, and exercise as part of cancer treatment
Measured: Baseline
Patient preferences for receiving exercise recommendations via pilot survey
Investigator created survey with 14 items regarding demographics, cancer history, exercise habits, and exercise as part of cancer treatment
Measured: Baseline
Provider perceived barriers to making exercise recommendations via pilot survey
Investigator created survey with 14 items regarding demographics, cancer speciality, exercise habits, and exercise recommendations to patients and patient exercise habits
Measured: Baseline
Provider preferences for exercise and physical activity resources that could be provided by the cancer center via pilot survey
Investigator created survey with 14 items regarding demographics, cancer speciality, exercise habits, and exercise recommendations to patients and patient exercise habits
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start8 Apr 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarah J Ballinger, MD, Indiana University
- Investigators
- Tarah Ballinger, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047589
- Sponsor's protocol ID
- IUSCC-0690
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2019
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Exercise Behavior and Preferences Among Patients and Oncologists at Indiana University Simon Cancer Center
- ClinicalTrials.gov ID
- NCT04047589
- Acronym / sponsor ID
- IUSCC-0690
- Conditions
- Solid Tumor, Exercise
- Keywords
- solid tumor, exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 7 Aug 2019 (actual)
- 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 purpose of this study is to understand the preferences and barriers surrounding exercise of both the patients and oncologists within Indiana University Simon Cancer Center. This information will establish gaps in our current care and provide important information to guide future pilot interventions.
Detailed description
This descriptive, cross-sectional study will survey patients with a current or previous diagnosis of non-metastatic solid tumor malignancy who are being seen at the Indiana University Simon Cancer in Indianapolis, Indiana. Patients with active, incurable disease are excluded. Willing and eligible patients will complete a brief, 14 question survey while seen in the waiting room of the women's or multi-disciplinary clinics. We aim to survey 350 patients over a 12 month period. Patients will fill out the survey at only one point in time and no patient identifiers will be kept.
During COVID-19 restrictions, we will also send out an electronic version of the survey to participants using the email address provided in their Cerner accounts. Responses will be captured by REDCAP and will remain anonymous and not linked to the patients' medical record or personal health information.
The physician survey will be emailed to oncologist/hematologists practicing within IUSCC who see patients at least once per week. Physicians will receive a survey at only one point in time. The survey will be anonymous and no physician identifiers will be kept.
Primary objective Estimate the proportion of patients with curable solid tumor malignancies seen at the Indiana University Simon Cancer Center who are meeting exercise recommendations for cancer survivors (more than 150 minutes per week of moderate or 75 minutes per week of vigorous activity).
Secondary objectives
- Assess patients' perceived barriers to exercise during cancer survivorship
- Assess patients' preferences for receiving exercise recommendations
- Assess oncologists' perceived barriers to making exercise recommendations
- Assess oncologists' preferences for exercise and physical activity resources that could be provided by the cancer center
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Behavioral: Survey regarding exercise habits, barriers to exercise, and experience with exercise services from the cancer center.Cancer patients with curable or previously treated malignancies |
| Providers | – | Behavioral: Survey regarding personal exercise habits and beliefs, barriers to making exercise recommendationsPhysicians seeing patients in the outpatient clinics at the IU Simon Cancer Center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential patients will be identified in the outpatient clinics (women's and multi-disciplinary) at the IU Simon Cancer Center. Physicians will be given the option of requesting that their patients not participate in the survey. When patients check in or are placed in an exam room, a trained member of the clinic staff will approach patients about possible participation in the survey study. Physicians seeing patients more than once per week in the outpatient clinics at the IU Simon Cancer Center will receive email invitation to participate in the survey. An online survey will be administered via Survey Monkey. This does not require an informed consent process. The survey has 14 questions and will take approximately 5 minutes to complete.
Key inclusion criteria (6 listed)
- Physician survey Any oncologist/hematologist practicing within IUSCC regularly providing care for patients with solid tumor malignancies (seeing patients one or more days per week in the multidisciplinary or women's clinics with solid tumor malignancies). Physicians providing care only for hematologic (multiple myeloma, leukemia, lymphoma, transplant) or benign disorders will be excluded.
- Patient survey
Key exclusion criteria (2 listed)
- Metastatic disease at the time of study participation
- Inability to complete the survey
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 |
|---|---|---|
| Survey regarding exercise habits, barriers to exercise, and experience with exercise services from the cancer center.Survey created at Indiana University to gain information regarding exercise habits, barriers to exercise, and experience with exercise services from the cancer center. | Behavioural | Subjects |
| Survey regarding personal exercise habits and beliefs, barriers to making exercise recommendationsSurvey regarding personal exercise habits and beliefs, barriers to making exercise recommendations, and potential resources the cancer center might provide to help make effective exercise recommendations in the future | Behavioural | Providers |
Primary outcome
Proportion of patients who meet exercise recommendations.
Time frame: baseline
Patients self-reporting more than 150 minutes per week of moderate physical activity OR more than 75 minutes per week of vigorous physical activity
4 secondary outcomes
Patient Perceived barriers to exercise during cancer survivorship via pilot survey
Time frame: Baseline
Patient preferences for receiving exercise recommendations via pilot survey
Time frame: Baseline
Provider perceived barriers to making exercise recommendations via pilot survey
Time frame: Baseline
Provider preferences for exercise and physical activity resources that could be provided by the cancer center via pilot survey
Time frame: Baseline
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 3 Aug 2023.
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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.
Tarah Ballinger, MD principal investigator
Indiana University
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 Solid Tumor and Exercise, run by Indiana University 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 2 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 3 Aug 2023. 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?
Proportion of patients who meet exercise recommendations. (time frame: baseline). 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 3 Aug 2023.