Exercise OncologySPAACESNCT06359210
Sustaining Physical Activity After Cancer Exercise Sessions
A study testing Responder Monthly Behavior Change Discussion Sessions, Incomplete Responder Monthly Behavior Change Discussion Sessions and Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions in people with Exercise Oncology and Physical Activity Behavior, run by Colorado State University at 3 sites in United States.
Trial summary
The goal of this clinical trial is to develop and test an adaptive physical activity (PA) maintenance intervention for cancer survivors, after participating in a community-based exercise oncology program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise Oncology, Physical Activity Behavior, Behavior Change Interventions
- What is being tested?
- Responder Monthly Behavior Change Discussion Sessions, Incomplete Responder Monthly Behavior Change Discussion Sessions and Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥18 years old,
- Able to speak/read English,
- Diagnosed with any type of cancer,
- Completed primary or adjuvant treatment (i.e., chemotherapy, radiation therapy, surgery) within the previous five years, with no planned treatment within the next nine months. This does not include long-term or chronic therapies such as anti-hormone or targeted therapies (e.g., aromatase inhibitor, androgen deprivation therapy),
- Participant is registered/enrolled to participate in one of three community-based exercise programs.
Who cannot join
- Existing participation in ≥90 minutes per week of at least moderate intensity aerobic exercise AND two or more days per week of resistance exercise or known contraindications for exercise.
- Known contraindications for non-medically supervised moderate or greater intensity exercise (e.g., uncontrolled hypertension, inability to walk without an assistive device)
- Current or planned participation in another exercise oncology program (not one of the three community partner exercise programs), or previous participation in another or one of the three community partner exercise programs in the past 12-months.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Recruiting
Anschutz Medical Center
Aurora, Colorado, 80045
Ryan Marker, PhD, PT, (720) 848-0300, ryan.marker@cuanschutz.edu
Ryan Marker, PhD, PT
- Active, not recruiting
Colorado State University
Fort Collins, Colorado, 80526
- Completed
University of Wyoming
Laramie, Wyoming, 82072
About this study
Official title: An Adaptive Physical Activity Maintenance Intervention
The goal of this clinical trial is to develop and test an adaptive physical activity (PA) maintenance intervention for cancer survivors, after participating in a community-based exercise oncology program. The main questions it aims to answer are:
- Aim 1: Examine the feasibility and acceptability of the intervention among cancer survivors and community partners. The researchers will utilize quantitative surveys, focus groups, and semi-structured interviews to collect information about feasibility, implementation, adaptation, and sustainability.
- Aim 2: Examine the effects of the intervention among cancer survivors. The researchers will compare the proportion of participants achieving the exercise guidelines for cancer survivors six-months following completion of the initial exercise program.
Participants will participate in a community-based exercise oncology program and then return to three months of free living. Based on the PA measured at the three-month follow-up, participants will be categorized as a "Responder" or "Incomplete Responder", and then randomized to the PA maintenance intervention. Researchers will compare those that are classified as Responders (meeting exercise guidelines for cancer survivors) and Incomplete Responders (not meeting guidelines for cancer survivors) to see what level of intervention is needed to influence sustainable behavior change in this population.
Read the detailed description
Structured leisure-time physical activity (PA) (i.e., aerobic and resistance exercise) is effective for improving multiple health outcomes related to a cancer diagnosis and cancer treatment and may reduce cancer-specific mortality by as much as 40%. Thus, if cancer survivors can achieve and maintain recommended exercise levels, the public health impact would be substantial.
Supervised exercise interventions that include theory-based behavior change strategies are effective for facilitating increases in moderate to vigorous, leisure-time PA among cancer survivors. However, few studies have focused on maintaining exercise or PA levels following completion of an intervention, and evidence regarding how exercise interventions for cancer survivors can be expanded to clinic or community practice is only now emerging. To achieve the physical, psychosocial, and survival benefits of exercise, survivors must be able to maintain PA long-term, and to support PA maintenance, a socio-ecological approach is necessary. Our approach is informed by theoretical frameworks including social cognitive theory and group dynamics, which will guide intrapersonal and interpersonal level intervention strategies. Integrated research-practice partnership models will guide strategies to address organizational and community-level influences.
The goal is to develop and test an adaptive randomized trial to enhance PA maintenance among cancer survivors. Our central hypothesis is that participants who have difficulty maintaining PA following a community-based exercise program will benefit from additional support in the form of bi-weekly exercise sessions and/or PA behavior change discussion sessions. Our long-term goal is to develop an evidence-based 'stepped' PA maintenance intervention for cancer survivors that can be disseminated to existing community-based cancer-exercise programs nationwide. In the proposed study, cancer survivors will participate in an existing, cancer-specific exercise program at a community-based facility.
All programs will consist of group-based, supervised, instructor-led aerobic and resistance exercise sessions 2x per week, and three PA behavior change discussion sessions. Upon completion of the program, participants will be encouraged to maintain PA levels during a three-month free-living period, during which time there will be no active intervention. After this follow-up period, PA will be measured, and based on PA response (i.e., achieving exercise guidelines for cancer survivors), participants will be randomized to a 3-month, stepped, PA maintenance intervention. The primary outcome of PA maintenance will be assessed six-months after completion of the initial exercise program.
- Being tested
- Responder Monthly Behavior Change Discussion Sessions, Incomplete Responder Monthly Behavior Change Discussion Sessions, Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions
- Keywords
- exercise oncology, physical activity, behavior change, adaptive intervention, cancer survivors, physical activity maintenance, community partnerships
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Responder Monthly Behavior Change Discussion SessionsBehavioural
Monthly behavior change discussion sessions (3 total) for 12 weeks.
Incomplete Responder Monthly Behavior Change Discussion SessionsBehavioural
Monthly behavior change discussion sessions (3 total) for 12 weeks.
Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise SessionsBehavioural
Monthly behavior change discussion sessions (3 total) for 12 weeks and attend bi-weekly (every other week) exercise classes that mirror the exercises completed in their respective community-based exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Group A- Complete Responder | No intervention | Participant is randomized to the no further intervention group. |
| Group B- Complete Responder | Experimental | Participant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions). Receives: Behavioral: Responder Monthly Behavior Change Discussion Sessions |
| Group C- Incomplete Responder | Experimental | Participant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions). Receives: Behavioral: Incomplete Responder Monthly Behavior Change Discussion Sessions |
| Group D- Incomplete Responder | Experimental | Participant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions) AND bi-weekly exercise sessions (total of six sessions). Receives: Behavioral: Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity program
Examine the number of participants achieving the exercise guidelines for cancer survivors defined as moderate-intensity aerobic training at least three times per week, for at least 30 minutes, and resistance training at least two times per week. Aerobic exercise will be measured with an accelerometer (continuous bouts of ≥5 minutes of activity at ≥3 METs) and resistance exercise will be measured with a self-report questionnaire (duration and frequency). The measures will be aggregated to determine total amount of physical activity and whether this amount meets or exceeds the recommended guidelines.
Measured: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
Secondary outcomes (3)
Quality of Life (QOL)
Measured using the Functional Assessment of Cancer Therapy-General (FACT-G), a quantitative, self-report measure of QOL. The FACT-G is a 27-item self-report measure, with subscales evaluating physical, social, emotional, and functional well-being. FACT-G scores range from 0 to 108, with higher total and subscale scores indicating better QOL.
Measured: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
Physical Fitness - Aerobic
Aerobic fitness will be assessed with either a submaximal, graded exercise test on a motorized, calibrated treadmill, or the two minute step test.
Measured: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
Physical Fitness - muscular strength and endurance
Muscular strength and endurance will be assessed by the number of full stands from a chair, and the number of bicep curls (holding a hand weight of 5lbs) that can be completed in 30 seconds.
Measured: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start4 Mar 2024
- Primary completion1 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise OncologyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- An adaptive design results in a final total of 4 possible subgroups, depending upon responder/non-responder status, and researchers plan to compare the proportion of participants achieving the minimum exercise guidelines for cancer survivors within the responders and incomplete responder subgroups. Admittedly however, it is not possible to fully elucidate the analyses the researchers will conduct, as researchers cannot predict the number of subgroups that participants will represent at the end of the trial (e.g., if there are no "incomplete responders" the design reduces to randomization to only two groups), nor the number of participants who will be in those subgroups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Heather Leach, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359210
- Sponsor's protocol ID
- 4973
- Other IDs
- 4R33CA256656-03
- Acronym
- SPAACES
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Physical Activity Maintenance Intervention
- ClinicalTrials.gov ID
- NCT06359210
- Acronym / sponsor ID
- SPAACES / 4973
- Keywords
- exercise oncology, physical activity, behavior change, adaptive intervention, cancer survivors, physical activity maintenance, community partnerships
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Apr 2024 (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 goal of this clinical trial is to develop and test an adaptive physical activity (PA) maintenance intervention for cancer survivors, after participating in a community-based exercise oncology program. The main questions it aims to answer are:
- Aim 1: Examine the feasibility and acceptability of the intervention among cancer survivors and community partners. The researchers will utilize quantitative surveys, focus groups, and semi-structured interviews to collect information about feasibility, implementation, adaptation, and sustainability.
- Aim 2: Examine the effects of the intervention among cancer survivors. The researchers will compare the proportion of participants achieving the exercise guidelines for cancer survivors six-months following completion of the initial exercise program.
Participants will participate in a community-based exercise oncology program and then return to three months of free living. Based on the PA measured at the three-month follow-up, participants will be categorized as a "Responder" or "Incomplete Responder", and then randomized to the PA maintenance intervention. Researchers will compare those that are classified as Responders (meeting exercise guidelines for cancer survivors) and Incomplete Responders (not meeting guidelines for cancer survivors) to see what level of intervention is needed to influence sustainable behavior change in this population.
Detailed description
Structured leisure-time physical activity (PA) (i.e., aerobic and resistance exercise) is effective for improving multiple health outcomes related to a cancer diagnosis and cancer treatment and may reduce cancer-specific mortality by as much as 40%. Thus, if cancer survivors can achieve and maintain recommended exercise levels, the public health impact would be substantial.
Supervised exercise interventions that include theory-based behavior change strategies are effective for facilitating increases in moderate to vigorous, leisure-time PA among cancer survivors. However, few studies have focused on maintaining exercise or PA levels following completion of an intervention, and evidence regarding how exercise interventions for cancer survivors can be expanded to clinic or community practice is only now emerging. To achieve the physical, psychosocial, and survival benefits of exercise, survivors must be able to maintain PA long-term, and to support PA maintenance, a socio-ecological approach is necessary. Our approach is informed by theoretical frameworks including social cognitive theory and group dynamics, which will guide intrapersonal and interpersonal level intervention strategies. Integrated research-practice partnership models will guide strategies to address organizational and community-level influences.
The goal is to develop and test an adaptive randomized trial to enhance PA maintenance among cancer survivors. Our central hypothesis is that participants who have difficulty maintaining PA following a community-based exercise program will benefit from additional support in the form of bi-weekly exercise sessions and/or PA behavior change discussion sessions. Our long-term goal is to develop an evidence-based 'stepped' PA maintenance intervention for cancer survivors that can be disseminated to existing community-based cancer-exercise programs nationwide. In the proposed study, cancer survivors will participate in an existing, cancer-specific exercise program at a community-based facility.
All programs will consist of group-based, supervised, instructor-led aerobic and resistance exercise sessions 2x per week, and three PA behavior change discussion sessions. Upon completion of the program, participants will be encouraged to maintain PA levels during a three-month free-living period, during which time there will be no active intervention. After this follow-up period, PA will be measured, and based on PA response (i.e., achieving exercise guidelines for cancer survivors), participants will be randomized to a 3-month, stepped, PA maintenance intervention. The primary outcome of PA maintenance will be assessed six-months after completion of the initial exercise program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- An adaptive design results in a final total of 4 possible subgroups, depending upon responder/non-responder status, and researchers plan to compare the proportion of participants achieving the minimum exercise guidelines for cancer survivors within the responders and incomplete responder subgroups. Admittedly however, it is not possible to fully elucidate the analyses the researchers will conduct, as researchers cannot predict the number of subgroups that participants will represent at the end of the trial (e.g., if there are no "incomplete responders" the design reduces to randomization to only two groups), nor the number of participants who will be in those subgroups
| Arm | Type | Receives |
|---|---|---|
| Group A- Complete Responder | No intervention | –Participant is randomized to the no further intervention group. |
| Group B- Complete Responder | Experimental | Behavioral: Responder Monthly Behavior Change Discussion SessionsParticipant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions). |
| Group C- Incomplete Responder | Experimental | Behavioral: Incomplete Responder Monthly Behavior Change Discussion SessionsParticipant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions). |
| Group D- Incomplete Responder | Experimental | Behavioral: Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise SessionsParticipant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions) AND bi-weekly exercise sessions (total of six sessions). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old,
- Able to speak/read English,
- Diagnosed with any type of cancer,
- Completed primary or adjuvant treatment (i.e., chemotherapy, radiation therapy, surgery) within the previous five years, with no planned treatment within the next nine months. This does not include long-term or chronic therapies such as anti-hormone or targeted therapies (e.g., aromatase inhibitor, androgen deprivation therapy),
- Participant is registered/enrolled to participate in one of three community-based exercise programs.
Key exclusion criteria (3 listed)
- Existing participation in ≥90 minutes per week of at least moderate intensity aerobic exercise AND two or more days per week of resistance exercise or known contraindications for exercise.
- Known contraindications for non-medically supervised moderate or greater intensity exercise (e.g., uncontrolled hypertension, inability to walk without an assistive device)
- Current or planned participation in another exercise oncology program (not one of the three community partner exercise programs), or previous participation in another or one of the three community partner exercise programs in the past 12-months.
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 |
|---|---|---|
| Responder Monthly Behavior Change Discussion SessionsMonthly behavior change discussion sessions (3 total) for 12 weeks. | Behavioural | Group B- Complete Responder |
| Incomplete Responder Monthly Behavior Change Discussion SessionsMonthly behavior change discussion sessions (3 total) for 12 weeks. | Behavioural | Group C- Incomplete Responder |
| Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise SessionsMonthly behavior change discussion sessions (3 total) for 12 weeks and attend bi-weekly (every other week) exercise classes that mirror the exercises completed in their respective community-based exercise program. | Behavioural | Group D- Incomplete Responder |
Primary outcome
Physical Activity program
Time frame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
Examine the number of participants achieving the exercise guidelines for cancer survivors defined as moderate-intensity aerobic training at least three times per week, for at least 30 minutes, and resistance training at least two times per week. Aerobic exercise will be measured with an accelerometer (continuous bouts of ≥5 minutes of activity at ≥3 METs) and resistance exercise will be measured with a self-report questionnaire (duration and frequency). The measures will be aggregated to determine total amount of physical activity and whether this amount meets or exceeds the recommended guidelines.
3 secondary outcomes
Quality of Life (QOL)
Time frame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
Physical Fitness - Aerobic
Time frame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
Physical Fitness - muscular strength and endurance
Time frame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Responder Monthly Behavior Change Discussion Sessions, Incomplete Responder Monthly Behavior Change Discussion Sessions and Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions in people with Exercise Oncology and Physical Activity Behavior, run by Colorado State University at 3 sites 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Leach, PhD (970-491-8951, heather.leach@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity program (time frame: Measured at baseline, after completion of the exercise program (either 8-weeks or 12-weeks), 3-months post program, and 6-months post program). 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 19 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.