Cancer SurvivorsNCT04498130
Feasibility of a Novel, Theory Based Physical Activity Intervention Among Adult Cancer Survivors
A study testing 12-Week Home Exercise Group and Education Comparison Group in people with Cancer Survivors and Exercise, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
As the number of cancer survivors grows and expected survival time increases, the health behaviors of this population are gaining significant attention from the research and public health community. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivors, Exercise, Sedentary Behavior
- What is being tested?
- 12-Week Home Exercise Group and Education Comparison Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2021to 31 Dec 2022
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30-75 years of age at baseline
- Cancer diagnosis during adulthood (no childhood cancers)
- Low-active (≤ 2 days of 30 minutes of structured exercise/week)
- At least 1 month since last cancer treatment (surgery, chemotherapy and/or radiation)
- No reservations from a doctor/physician/oncologist to engage in physical activity
- Not currently undergoing cancer-related treatment
Show all 13Show fewer
- No active cancer diagnosis
- Willingness to participate in a 12-week home exercise program
- Willingness to be randomized to either the 12-week home exercise or a 12 week education group
- Access to a laptop/ phone with Zoom web-conferencing software
- An active email address to receive and sign the electronic informed consent
- Willingness to complete study questionnaires before and after the 12-week program, and 3 months after the program
- Fluency in English
Who cannot join
- Below 30 or above 75 of age at baseline
- Childhood cancer diagnosis only
- High active (> 2 days of 30 minutes of structured exercise/week)
- Cancer treatment within the last month or currently undergoing treatment
- Advised to refrain from physical activity by a doctor/physician/oncologist
- Active cancer diagnosis
Show all 11Show fewer
- Not willing to participate in a 12-week home exercise group and/or complete study assessments
- Not willing to be randomized into one of the two study groups
- No access to a laptop/phone with Zoom software
- No access to active email
- Not fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Designing and Testing the Feasibility of a Theory-Based Intervention to Promote Physical Activity Among Cancer Survivors
As the number of cancer survivors grows and expected survival time increases, the health behaviors of this population are gaining significant attention from the research and public health community. Adoption or maintenance of healthy lifestyles after cancer has the potential to reduce both cancer- and non-cancer-related morbidity and mortality. Exercise adoption and maintenance remains a significant challenge for adults, especially clinical populations such as cancer survivors who may struggle with comorbidities, symptoms and side-effects of the disease or medications, and overall compromised health and functioning. A number of site-based exercise interventions have been conducted to promote physical activity, often using a theoretical basis to design and execute the intervention. Although these programs are successful in exposing cancer survivors to regular physical activity, they often struggle with exercise maintenance after the conclusion of the structured site-based group exercise sessions. The goal of the proposed project is to enhance physical activity engagement among adult cancer survivors by designing a home-based program using the socio-ecological framework and employing constructs from social cognitive theory to guide participants through the project.
- Conditions
- Cancer Survivors, Exercise, Sedentary Behavior
- Being tested
- 12-Week Home Exercise Group, Education Comparison Group
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-Week Home Exercise GroupBehavioural
12 week home-based program consisting of: weekly Zoom group chats; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page
Education Comparison GroupBehavioural
12 week home-based program consisting of: weekly check-in phone calls; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page.
| Study group | Role | What they receive |
|---|---|---|
| 12-Week Home Exercise Group | Experimental | The 12-week theory-based physical activity intervention will involve mailing participants an exercise manual with health and exercise information (i.e. information about exercising safely, modules related to the social cognitive theory, weekly goal setting worksheets, exercise-tracking logs, etc.), a resistance band, and a standard Omron pedometer. Participants will receive a weekly 30-minute Zoom--based group meetings to discuss different strategies to begin and maintain a consistent exercise routine and access to a social media page to facilitate social support and interaction among the group participants. Participants will be able to join the group if they would like, but it will not be required. Participants will be encouraged to connect with each other to promote social support and social modeling. Lastly participants will receive a weekly exercise video to follow along with on their own time and tailored weekly step goals. Receives: Behavioral: 12-Week Home Exercise Group |
| Educational Comparison Group | Active comparator | The education group participants will receive the same exercise manual, fitness items, exercise videos, and same weekly tailored step goal as the 12-week intervention group. This group will not have weekly zoom discussions, or be a part of the same social media page as the 12-week intervention group. Instead, the education group will be contacted by research staff once a week via telephone to discuss their manuals and activity for the week, and to ensure they have been safely engaging in exercise. A separate social media page will be created for this group, where pre-existing materials related to physical activity recommendations, benefits, other resources, and more will be shared. Receives: Behavioral: Education Comparison Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Zoom-Based Exercise Coaching
Participants in the intervention arm will answer Likert-format questions relating to their preference, tolerance and usage of the Zoom-based group meetings to promote physical activity levels. The scale will use a 1-5 rating, with 1 being lowest preference/displeased and 10 being the highest preference/very pleased.
Measured: 12 weeks
Change in average daily step count
Participants will wear a hip-based pedometer for 7 days at baseline, 12 weeks and 24 weeks.
Measured: Baseline, 12 weeks, 24 weeks
Change in minutes of daily sedentary time
The Sedentary Behavior Questionnaire (developed by Rosenberg et al., 2010) will be administered at baseline,12 weeks and 24 weeks to assess participants' time spent sitting. Questions relating to sedentary behavior cover both weekday and weekend sitting time, as well as domain-specific sedentary behaviors (i.e. occupational, transportation, and leisure sitting time).Response options for the amount of time engaged in each behavior include: none, 15 minutes or less, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, or 6 hours or more. For scoring, the time spent in each behavior is converted into hours, and the hours per day for each item are summed separately for weekdays and weekend days. Higher scores indicate higher amounts of daily sitting time.
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (2)
Use of the exercise manual
Participants in both groups will answer Likert-format questions relating to their preference, usage and perceived helpfulness of the study-specific exercise manual. The scale will use a 1-10 rating, with 1 being lowest preference/displeased and 10 being the highest preference/very pleased.
Measured: 12 weeks
Change in physical activity engagement
The Godin-Shepard Leisure Time Exercise Questionnaire will be administered at baseline, 12 weeks and 24 weeks to assess individuals' reported weekly frequency of engaging in light, moderate and strenuous vigorous-intensity exercise. For each intensity level, participants will report the number of times per week they engaged in an exercise bout >=10 minutes and the average duration of the bouts. For each intensity level, the number of bouts per week will be multiplied by the average duration per bout to reflect participant's average activity level.
Measured: Baseline,12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start2 Oct 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha P Gothe, MA, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498130
- Sponsor's protocol ID
- 21591
- Status last verified
- Jan 2023
- First submitted
- 23 Mar 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing and Testing the Feasibility of a Theory-Based Intervention to Promote Physical Activity Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT04498130
- Acronym / sponsor ID
- 21591
- Conditions
- Cancer Survivors, Exercise, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 2 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Aug 2020 (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.
As the number of cancer survivors grows and expected survival time increases, the health behaviors of this population are gaining significant attention from the research and public health community. Adoption or maintenance of healthy lifestyles after cancer has the potential to reduce both cancer- and non-cancer-related morbidity and mortality. Exercise adoption and maintenance remains a significant challenge for adults, especially clinical populations such as cancer survivors who may struggle with comorbidities, symptoms and side-effects of the disease or medications, and overall compromised health and functioning. A number of site-based exercise interventions have been conducted to promote physical activity, often using a theoretical basis to design and execute the intervention. Although these programs are successful in exposing cancer survivors to regular physical activity, they often struggle with exercise maintenance after the conclusion of the structured site-based group exercise sessions. The goal of the proposed project is to enhance physical activity engagement among adult cancer survivors by designing a home-based program using the socio-ecological framework and employing constructs from social cognitive theory to guide participants through the project.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-Week Home Exercise Group | Experimental | Behavioral: 12-Week Home Exercise GroupThe 12-week theory-based physical activity intervention will involve mailing participants an exercise manual with health and exercise information (i.e. information about exercising safely, modules related to the social cognitive theory, weekly goal setting worksheets, exercise-tracking logs, etc.), a resistance band, and a standard Omron pedometer. Participants will receive a weekly 30-minute Zoom--based group meetings to discuss different strategies to begin and maintain a consistent exercise routine and access to a social media page to facilitate social support and interaction among the group participants. Participants will be able to join the group if they would like, but it will not be required. Participants will be encouraged to connect with each other to promote social support and social modeling. Lastly participants will receive a weekly exercise video to follow along with on their own time and tailored weekly step goals. |
| Educational Comparison Group | Active comparator | Behavioral: Education Comparison GroupThe education group participants will receive the same exercise manual, fitness items, exercise videos, and same weekly tailored step goal as the 12-week intervention group. This group will not have weekly zoom discussions, or be a part of the same social media page as the 12-week intervention group. Instead, the education group will be contacted by research staff once a week via telephone to discuss their manuals and activity for the week, and to ensure they have been safely engaging in exercise. A separate social media page will be created for this group, where pre-existing materials related to physical activity recommendations, benefits, other resources, and more will be shared. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 30-75 years of age at baseline
- Cancer diagnosis during adulthood (no childhood cancers)
- Low-active (≤ 2 days of 30 minutes of structured exercise/week)
- At least 1 month since last cancer treatment (surgery, chemotherapy and/or radiation)
- No reservations from a doctor/physician/oncologist to engage in physical activity
Key exclusion criteria (11 listed)
- Below 30 or above 75 of age at baseline
- Childhood cancer diagnosis only
- High active (> 2 days of 30 minutes of structured exercise/week)
- Cancer treatment within the last month or currently undergoing treatment
- Advised to refrain from physical activity by a doctor/physician/oncologist
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 |
|---|---|---|
| 12-Week Home Exercise Group12 week home-based program consisting of: weekly Zoom group chats; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page | Behavioural | 12-Week Home Exercise Group |
| Education Comparison Group12 week home-based program consisting of: weekly check-in phone calls; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page. | Behavioural | Educational Comparison Group |
Primary outcome
Feasibility of Zoom-Based Exercise Coaching
Time frame: 12 weeks
Participants in the intervention arm will answer Likert-format questions relating to their preference, tolerance and usage of the Zoom-based group meetings to promote physical activity levels. The scale will use a 1-5 rating, with 1 being lowest preference/displeased and 10 being the highest preference/very pleased.
Change in average daily step count
Time frame: Baseline, 12 weeks, 24 weeks
Participants will wear a hip-based pedometer for 7 days at baseline, 12 weeks and 24 weeks.
Change in minutes of daily sedentary time
Time frame: Baseline, 12 weeks, 24 weeks
The Sedentary Behavior Questionnaire (developed by Rosenberg et al., 2010) will be administered at baseline,12 weeks and 24 weeks to assess participants' time spent sitting. Questions relating to sedentary behavior cover both weekday and weekend sitting time, as well as domain-specific sedentary behaviors (i.e. occupational, transportation, and leisure sitting time).Response options for the amount of time engaged in each behavior include: none, 15 minutes or less, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, or 6 hours or more. For scoring, the time spent in each behavior is converted into hours, and the hours per day for each item are summed separately for weekdays and weekend days. Higher scores indicate higher amounts of daily sitting time.
2 secondary outcomes
Use of the exercise manual
Time frame: 12 weeks
Change in physical activity engagement
Time frame: Baseline,12 weeks, 24 weeks
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 31 Jan 2023.
Related trials for Cancer Survivors
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Recruiting
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Pediatric Brain Tumor
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.
Neha P Gothe, MA, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-Week Home Exercise Group and Education Comparison Group in people with Cancer Survivors and Exercise, run by University of Illinois at Urbana-Champaign 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 13 inclusion and 11 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 31 Jan 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?
Feasibility of Zoom-Based Exercise Coaching (time frame: 12 weeks). The study lists 3 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 31 Jan 2023.