Physical Activity Programs for Cancer Survivors

(SPAACES Trial)

Recruiting at 2 trial locations

Overseen By Heather Leach, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Colorado State University

Disqualifiers: High exercise levels, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help cancer survivors maintain physical activity after completing a community exercise program. It aims to evaluate the effectiveness of different activity maintenance strategies, such as monthly discussion sessions and additional exercise sessions, in keeping participants active. Individuals who have had any type of cancer, completed treatment within the last five years, and are enrolled in a community exercise program might be suitable candidates. Participants will be categorized based on their activity levels and will receive interventions to identify the best methods for encouraging long-term exercise habits. As an unphased trial, this study offers participants the chance to contribute to innovative strategies for sustaining physical activity after cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that long-term or chronic therapies like anti-hormone or targeted therapies are allowed.

What prior data suggests that this physical activity program is safe for cancer survivors?

In a previous study, cancer survivors found a web-based program for physical activity both practical and acceptable, suggesting that similar programs are well-received. Research has shown that exercise programs based on specific theories are safe and doable for overweight and obese female cancer survivors. Therefore, the planned exercise and discussion sessions in this trial should be safe and manageable.

Additionally, studies have shown that physical activity can improve quality of life and is generally easy for participants to maintain. This supports the idea that regular exercise sessions, like those in the trial, do not cause significant negative effects. Overall, these findings suggest that the treatments tested in this study are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for cancer survivors because they take a personalized approach to increasing physical activity, which can be crucial for recovery. Unlike standard treatments that may not focus specifically on physical activity, these programs include personalized behavior change discussions and exercise sessions tailored to participants' needs. The unique combination of monthly discussions and bi-weekly exercise sessions could offer a more structured and supportive way to help participants become more active, potentially improving their overall health and quality of life after cancer treatment.

What evidence suggests that this trial's physical activity programs could be effective for cancer survivors?

This trial will compare different physical activity programs for cancer survivors. Studies have shown that exercise programs can help cancer survivors maintain better health. In this trial, some participants will receive monthly behavior change discussion sessions, while others will receive these sessions combined with bi-weekly exercise sessions. Research indicates that meeting with a counselor in person can encourage cancer survivors to be more active. For those who might not exercise enough on their own, combining these meetings with regular exercise classes has proven effective. A previous study showed that these methods helped cancer survivors become more active after three months. These findings suggest that structured support can significantly aid in maintaining physical activity, which is crucial for managing cancer-related side effects and improving overall well-being. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for cancer survivors who have completed a community-based exercise program. They are being studied to see if additional support can help them keep up with physical activity. Participants will be labeled as 'Responders' or 'Incomplete Responders' based on their exercise habits after three months of free living.

Inclusion Criteria

Able to speak/read English

I have been diagnosed with cancer.

Participant is registered/enrolled to participate in one of three community-based exercise programs

Exclusion Criteria

Known contraindications for non-medically supervised moderate or greater intensity exercise (e.g., uncontrolled hypertension, inability to walk without an assistive device)

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Exercise Program

Participants engage in a community-based exercise oncology program consisting of group-based, supervised, instructor-led aerobic and resistance exercise sessions 2x per week, and three PA behavior change discussion sessions.

8-12 weeks

Free-living Period

Participants are encouraged to maintain PA levels during a three-month free-living period with no active intervention.

12 weeks

PA Maintenance Intervention

Based on PA response, participants are randomized to a 3-month, stepped, PA maintenance intervention involving bi-weekly exercise sessions and/or PA behavior change discussion sessions.

12 weeks

Follow-up

Participants are monitored for PA maintenance and other outcomes such as physical fitness and quality of life.

6 months post program

What Are the Treatments Tested in This Trial?

Interventions

• Incomplete Responder Monthly Behavior Change Discussion Sessions
• Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions
• Responder Monthly Behavior Change Discussion Sessions

Trial Overview The study tests an adaptive physical activity maintenance intervention. It includes monthly behavior change discussions for all, plus bi-weekly exercise sessions for some incomplete responders. The goal is to see if these interventions help maintain regular exercise six months post-program.

How Is the Trial Designed?

Group I: Group D- Incomplete Responder Experimental Treatment 1 Intervention

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).

Group II: Group C- Incomplete Responder Experimental Treatment 1 Intervention

Participant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions).

Group III: Group B- Complete Responder Experimental Treatment 1 Intervention

Participant is randomized to receive monthly physical activity behavior change discussion sessions for 3-months (total of three sessions).

Group IV: Group A- Complete Responder Active Control 1 Intervention

Participant is randomized to the no further intervention group.

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Face-to-face behavior change counseling (BCC) interventions significantly increase physical activity in adult cancer survivors, with a small effect size (SMD 0.22) based on a meta-analysis of 14 studies.

Effective BCC interventions often included techniques such as 'graded tasks', 'self-monitoring of behavior', and 'action planning', suggesting these strategies are key to enhancing physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of face-to-face behavior change counseling interventions on physical activity behavior in cancer survivors - a systematic review and meta-analysis. Meyer-Schwickerath, C., Morawietz, C., Baumann, FT., et al.[2022]

Cancer survivors show a strong interest in participating in physical activity (PA) programs, particularly preferring walking as their main exercise modality and moderate intensity activities.

Tailoring PA programs to be home-based and scheduled in the morning can enhance participation and adherence among cancer survivors, highlighting the need for diverse program options to meet varying preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity programming and counseling preferences among cancer survivors: a systematic review. Wong, JN., McAuley, E., Trinh, L.[2023]

Interventions aimed at maintaining physical activity in cancer survivors were effective, resulting in a moderate increase in moderate to vigorous physical activity (MVPA) of about 65 minutes per week compared to control groups, which saw an increase of 27 minutes per week.

However, many studies included in the review had biases, primarily involving younger, more active, and well-educated participants, suggesting that future interventions should focus on older adults and those with physical limitations to ensure broader applicability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of maintenance of physical activity behaviour change in cancer survivors. Grimmett, C., Corbett, T., Brunet, J., et al.[2021]

The study found that adding physical activity behavior change counseling (PABCC) to an exercise program for cancer survivors significantly increased their exercise self-efficacy by 21.5% and physical activity levels by 81.3%, compared to only 4.2% and 16.6% increases in the standard exercise program group.

While cancer survivors enjoyed the PABCC sessions, they felt that face-to-face delivery was time-consuming, and program staff expressed concerns about the sustainability of implementing PABCC due to perceived limitations in staff capacity and time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Implementing Physical Activity Behavior Change Counseling in an Existing Cancer-Exercise Program. McGinnis, EL., Rogers, LQ., Fruhauf, CA., et al.[2022]

The internet-delivered physical activity program (UCAN) had significant negative effects on motivation-related factors in cancer survivors, including self-efficacy and attitudes towards physical activity, as shown in a study of 95 participants.

Despite being based on the Theory of Planned Behaviour, the program did not improve motivation and may have methodological issues that affected the measurement of motivation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study on the motivational effects of an internet-delivered physical activity behaviour change programme in Nova Scotian cancer survivors. Forbes, CC., Blanchard, CM., Mummery, WK., et al.[2018]

A 12-week behavior change intervention significantly increased physical activity and improved health outcomes in sedentary breast cancer survivors, with notable improvements in physical activity counts, muscle strength, and social well-being among the 41 participants studied.

While the intervention showed positive effects, it also led to increased reports of joint stiffness, indicating the need for careful monitoring of side effects in future larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial to increase physical activity in breast cancer survivors. Rogers, LQ., Hopkins-Price, P., Vicari, S., et al.[2009]

Only 24% of the 206 randomized trials reviewed measured both the adoption and maintenance of physical activity in cancer survivors, indicating a significant gap in assessing long-term behavior change.

Interventions that included supervised exercise sessions and focused on improving quality of life were more successful in promoting both the adoption and maintenance of physical activity, suggesting that these strategies should be prioritized in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which Intervention Strategies Promote the Adoption and Maintenance of Physical Activity? Evidence From Behavioral Trials With Cancer Survivors. Sheeran, P., Wright, CE., Listrom, O., et al.[2023]

The AMPLIFI study is testing web-based diet and exercise interventions for middle-aged and older cancer survivors, focusing on improving health behaviors and reducing obesity-related risks through three randomized controlled trials involving multiple behavior change strategies.

The study will assess the efficacy of sequential versus simultaneous interventions over a 2-year period, measuring various health outcomes such as body mass index, physical activity, and muscle mass, using remote technologies for recruitment and assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. Pekmezi, D., Fontaine, K., Rogers, LQ., et al.[2023]

The ENRICH program, an 8-week intervention for cancer survivors, successfully maintained improvements in physical activity and weight over a 12-month follow-up, with participants increasing their moderate-to-vigorous physical activity by 55 minutes per week.

While physical activity and weight management showed positive long-term effects, there was a significant decline in vegetable consumption, highlighting the need for ongoing support to help cancer survivors maintain dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of Lifestyle Changes at 12-month Follow-up in a Nutrition and Physical Activity Trial for Cancer Survivors. Stacey, FG., Lubans, DR., Chapman, K., et al.[2022]

A supervised group exercise program for breast cancer survivors showed significant positive effects on motivational outcomes, particularly on descriptive norms, even 5 years after the intervention, suggesting lasting benefits of the program.

Participants who remained active at the 5-year follow-up reported more favorable attitudes and perceptions related to physical activity, indicating that initial exercise programs may help sustain long-term engagement in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of supervised exercise on motivational outcomes in breast cancer survivors at 5-year follow-up. Trinh, L., Mutrie, N., Campbell, AM., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06359210

Sustaining Physical Activity After Cancer Exercise Sessions The goal of this clinical trial is to develop and test an adaptive physical activity (PA) maintenance intervention for cancer survivors, after participating ...

2. reporter.nih.gov reporter.nih.gov/project-details/11160649

An adaptive physical activity maintenance intervention for cancer ... We will enroll cancer survivors who are not currently achieving aerobic and resistance exercise guidelines in a three-month, supervised, group-based exercise ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8099708/

Pilot Randomized Controlled Trial of Feasibility, Acceptability ... This pilot study explored the feasibility, acceptability, and usability of a web-based intervention for survivors of physical inactivity-related cancers.

4. withpower.com withpower.com/trial/phase-neoplasms-2-2024-bdf91

Physical Activity Programs for Cancer Survivors (SPAACES Trial) Research shows that face-to-face behavior change counseling can effectively increase physical activity in cancer survivors, and implementing these sessions in ...

5. aacrjournals.org aacrjournals.org/cebp/article/18/5/1410/164620/Physical-Activity-and-Health-Outcomes-Three-Months

Physical Activity and Health Outcomes Three Months After ... Abstract. Purpose: We previously reported the effectiveness of a 12-week physical activity behavior change intervention for breast cancer survivors.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06624930

Behaviour Change for Cancer Survivors Trial This study will be a two-arm RCT, to examine the effects of an entirely virtual, 6-month supervised PA program plus standard exercise counselling (PA+EC) ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023044171

An application of a series of theory-based educational ... This study was designed to figure out how a theory-based educational intervention can affect the skin cancer prevention practices of Iranian female high school ...

8. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-019-0787-4

Systematic review and meta-analysis of maintenance of ... This review evaluates the effectiveness of interventions in supporting maintenance of physical activity behaviour change among adults diagnosed with cancer

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7853491/

Perceptions of changes in clinical, informational, and ... This period is seen by parents as uniquely distressing because it represents a disruption of the hard-won safety represented by regular clinical relationships.