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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Physical Activity Programs for Cancer Survivors?

Research shows that face-to-face behavior change counseling can effectively increase physical activity in cancer survivors, and implementing these sessions in existing exercise programs is feasible and well-received. Additionally, supervised exercise programs have been shown to improve motivation and physical activity levels in breast cancer survivors over the long term. ^{1 2 3 4 5}

Is the physical activity program for cancer survivors safe?

The research does not specifically address safety concerns, but physical activity programs for cancer survivors are generally considered safe when properly supervised and tailored to individual needs. ^{1 2 4 6 7}

How does the physical activity program for cancer survivors differ from other treatments?

This treatment is unique because it focuses on maintaining long-term physical activity habits in cancer survivors, which can improve health and potentially reduce cancer recurrence. Unlike traditional treatments that may focus on medication or surgery, this program emphasizes behavior change and motivation to stay active, often using tailored and internet-delivered interventions. ^{2 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Which Intervention Strategies Promote the Adoption and Maintenance of Physical Activity? Evidence From Behavioral Trials With Cancer Survivors. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Implementing Physical Activity Behavior Change Counseling in an Existing Cancer-Exercise Program. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Maintenance of Lifestyle Changes at 12-month Follow-up in a Nutrition and Physical Activity Trial for Cancer Survivors. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

Effects of supervised exercise on motivational outcomes in breast cancer survivors at 5-year follow-up. [2016]

6. England 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized trial to increase physical activity in breast cancer survivors. [2009]

8. England 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. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Physical activity programming and counseling preferences among cancer survivors: a systematic review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of maintenance of physical activity behaviour change in cancer survivors. [2021]