Cross-Training Program for Cancer Survivors

(CAPABLE Trial)

Overseen By Jennifer B Beebe-Dimmer, MPH, PhD.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Barbara Ann Karmanos Cancer Institute

Disqualifiers: Under 18, No cancer diagnosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will introduce cancer survivors to cross-training with the expectation that the program proposed will ultimately result in superior improvements in functional performance, body composition and quality of life compared with the current American Cancer Society (ACS) guidelines for cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to ensure it's safe to participate.

Is the Cross-Training Program for Cancer Survivors safe for humans?

The research articles reviewed do not provide specific safety data for the Cross-Training Program for Cancer Survivors or similar interventions. However, they suggest that physical activity programs are generally beneficial and improve health outcomes for cancer survivors, indicating a level of safety in such interventions. ^{1 2 3 4 5}

How is the Cross-Training Program for Cancer Survivors different from other treatments?

The Cross-Training Program for Cancer Survivors is unique because it focuses on a structured physical activity regimen, which is not a standard treatment for cancer survivors. This program aims to improve physical and emotional well-being through exercise, unlike traditional treatments that primarily focus on medical interventions. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment C.A.P.A.B.L.E. for cancer survivors?

Research shows that physical exercise can help cancer survivors recover from treatment, improve their health, and potentially extend their survival. Exercise is beneficial for cancer survivors, although the exact type and amount needed are still being studied. ^{1 2 9 10 11}

Who Is on the Research Team?

Jennifer Beebe-Dimmer, MPH, PhD.

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Are You a Good Fit for This Trial?

This trial is for cancer survivors who are 18 or older and have been diagnosed with invasive cancer. They must be cleared by their doctor to join the program, which could include those currently in treatment or those who've finished. Participants need a way to get to the facility on session days.

Inclusion Criteria

Cleared from their physician to participate in the program (We assume that most patients will have completed treatment, however if a patient is currently under treatment, this should be their oncologist. If the patient is not currently undergoing treatment, this could be primary care physician or oncologist).

I have a way to get to and from the clinic on my appointment days.

I have been diagnosed with a cancer that is spreading into surrounding tissues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week high-intensity functional training program to improve functional performance, body composition, and quality of life

12 weeks

Weekly surveys and monthly physical assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 12 week pilot intervention study

Trial Overview The study tests a 12-week cross-training program against current American Cancer Society guidelines for cancer survivors. It aims to see if this new approach can better improve functional performance, body composition, and quality of life.

How Is the Trial Designed?

Group I: A 12-week pilot intervention study introducing a high-intensi Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Barbara Ann Karmanos Cancer Institute

Lead Sponsor

Trials

166

Recruited

9,300+

Published Research Related to This Trial

Regular physical exercise is associated with a reduced risk of developing colorectal and breast cancer, and may also lower the risk for prostate, endometrial, and lung cancers, based on a review of recent literature.

Exercise is beneficial for cancer survivors, aiding in recovery from treatment and potentially extending survival, although specific guidelines on the optimal amount, type, and intensity of exercise are still being developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in cancer. Rajarajeswaran, P., Vishnupriya, R.[2021]

Physical activity has been shown to significantly improve both patient-reported outcomes and physiological health in cancer survivors during and after treatment, highlighting its importance in recovery.

The review discusses ongoing phase III trials that are investigating the impact of physical activity on clinical disease endpoints, suggesting a strong focus on integrating exercise into cancer care to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions. Brown, JC., Ligibel, JA.[2023]

Only 23% of breast, prostate, and colorectal cancer survivors in Nova Scotia meet the recommended strength exercise guidelines of two or more days per week, indicating a need for increased physical activity among this population.

Younger age, higher education, better income, and perceived health were associated with a higher likelihood of meeting strength exercise guidelines, suggesting that targeted interventions could help improve exercise participation among those at higher risk of inactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and correlates of strength exercise among breast, prostate, and colorectal cancer survivors. Forbes, CC., Blanchard, CM., Mummery, WK., et al.[2022]

Only about 34% of young-old (ages 65-74) and 35% of old-old (ages 75 and above) cancer survivors in the U.S. meet the recommended levels of aerobic physical activity, which is significantly lower than the 44% adherence rate in middle-aged cancer survivors (ages 45-64).

Approximately 10% of older cancer survivors meet both aerobic and muscle-strengthening activity guidelines, highlighting a need for increased support and encouragement for physical activity in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Reported Physical Activity Levels of Older Cancer Survivors: Results from the 2014 National Health Interview Survey. Tarasenko, Y., Chen, C., Schoenberg, N.[2017]

Exercise interventions significantly improve the quality of life (QOL) in cancer survivors, with more intense aerobic exercise showing particularly strong effects.

The benefits of exercise on QOL are especially pronounced in women and are more effective in studies with higher methodological quality and longer intervention durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions for cancer survivors: a meta-analysis of quality of life outcomes. Ferrer, RA., Huedo-Medina, TB., Johnson, BT., et al.[2022]

Theory-based physical activity interventions for overweight and obese female cancer survivors are safe and feasible, with high adherence and retention rates, and they can lead to moderate to large improvements in physical activity, especially when including a center-based component.

Health-related outcomes showed positive effects, such as improvements in aerobic fitness and significant reductions in waist circumference, while only one serious adverse event was reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Theory-Based Behavioral Interventions on Physical Activity Among Overweight and Obese Female Cancer Survivors: A Systematic Review of Randomized Controlled Trials. Rossi, A., Friel, C., Carter, L., et al.[2019]

The BEAT Cancer physical activity intervention significantly improved physical and mental health outcomes in breast cancer survivors, with notable enhancements in SF-36 scores and lower extremity dysfunction after 3 months compared to usual care, involving 222 participants.

Improvements in mental health and vitality were sustained even 3 months after the intervention, indicating long-term benefits, while various factors like baseline health and income influenced the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a multicomponent physical activity behavior change intervention on breast cancer survivor health status outcomes in a randomized controlled trial. Rogers, LQ., Courneya, KS., Carter, SJ., et al.[2018]

Adding behavioral counseling to a 4-week supervised physical activity program for kidney cancer survivors showed feasibility and a potential increase in physical activity levels, although the increase was not statistically significant.

Participants receiving behavioral counseling improved their 6-minute walk distance significantly more than those receiving standard exercise counseling, suggesting that behavioral strategies may enhance fitness outcomes in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of adding behavioral counseling to supervised physical activity in kidney cancer survivors: a randomized controlled trial. Trinh, L., Plotnikoff, RC., Rhodes, RE., et al.[2014]

Among cancer survivors, exercising in the afternoon (PM) led to significant improvements in fitness and lower-body muscular endurance, while morning (AM) or mixed exercise times did not show these benefits.

Mixed exercise timing was associated with less favorable outcomes, including increases in waist circumference, body weight, and BMI, suggesting that consistent AM or PM exercise may be better for weight management and overall health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between time-of-day of habitual exercise training and changes in relevant cancer health outcomes among cancer survivors. Coletta, AM., Playdon, MC., Baron, KG., et al.[2023]

In a study of 1003 adult cancer survivors, those who believed that physical activity (PA) improves their quality of life and overall survival were significantly more likely to meet moderate to vigorous PA guidelines after treatment, highlighting the importance of patient perceptions in promoting activity levels.

Only 32% of patients met PA guidelines before diagnosis, but 50% of those who did maintained this after treatment, suggesting that factors like better health status and receiving curative therapy can help sustain PA levels post-cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns, perceptions, and perceived barriers to physical activity in adult cancer survivors. Eng, L., Pringle, D., Su, J., et al.[2018]

In a study of 3710 postmenopausal breast cancer survivors with an average age of 78.8 years, factors such as higher education, better self-rated health, improved physical functioning, and greater social support were linked to increased participation in physical activity.

Younger survivors (under 75) who received radiation therapy engaged in more physical activity, while older survivors (85 and above) showed a unique trend where those with moderate pain exercised more than those without pain, suggesting that age and pain perception significantly influence physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of physical activity among older breast cancer survivors: Findings from the Women's Health Initiative LILAC study. Krok-Schoen, JL., Pennell, ML., Saquib, N., et al.[2023]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Exercise in cancer. [2021]

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

Putting Exercise Into Oncology Practice: State-of-the-Science, Innovation, and Future Directions. [2023]

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

Prevalence and correlates of strength exercise among breast, prostate, and colorectal cancer survivors. [2022]

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

Self-Reported Physical Activity Levels of Older Cancer Survivors: Results from the 2014 National Health Interview Survey. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Exercise interventions for cancer survivors: a meta-analysis of quality of life outcomes. [2022]

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

Effects of Theory-Based Behavioral Interventions on Physical Activity Among Overweight and Obese Female Cancer Survivors: A Systematic Review of Randomized Controlled Trials. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of a multicomponent physical activity behavior change intervention on breast cancer survivor health status outcomes in a randomized controlled trial. [2018]

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

Feasibility and preliminary efficacy of adding behavioral counseling to supervised physical activity in kidney cancer survivors: a randomized controlled trial. [2014]

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

The association between time-of-day of habitual exercise training and changes in relevant cancer health outcomes among cancer survivors. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Patterns, perceptions, and perceived barriers to physical activity in adult cancer survivors. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Correlates of physical activity among older breast cancer survivors: Findings from the Women's Health Initiative LILAC study. [2023]