38 Participants Needed

Physical Activity Program for Cancer Survivors

(CICI-PA Trial)

ZC
MK
Overseen ByMikhail Kellawan, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Oklahoma
Must be taking: Metformin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a new physical activity program can assist cancer survivors experiencing "chemo-brain" (memory and thinking problems after chemotherapy). Based on Social Cognitive Theory and delivered through technology, the program uses smartphone apps to guide exercise and health education and includes a Fitbit for tracking activity. The trial will compare cancer survivors with type 2 diabetes to those without, to understand differences in brain and heart health. Suitable candidates for this trial are cancer survivors who underwent chemotherapy in the last three years, are experiencing memory issues, and own a smartphone or computer with internet access. Participants should be prepared to join a 12-week exercise program delivered remotely. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance the quality of life 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. However, if you have Type 2 diabetes, you may continue using medications to treat hyperglycemia (high blood sugar).

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

Research has shown that programs based on social cognitive theory, like the one in this trial, are effective and safe for cancer survivors. One study found that using electronic devices and wearable technology to encourage physical activity was practical and well-received. These programs often help people become more active without causing major side effects.

Other studies on similar technology-based activity programs have also demonstrated positive outcomes. Participants typically experience improvements in their physical and mental health without serious negative effects. This suggests that the treatment in this trial is likely safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Social Cognitive Theory-based, Technology-delivered Physical Activity Program for cancer survivors because it offers a personalized approach to improving health outcomes. Unlike traditional physical therapy or group exercise classes, this program uses smartphone apps to deliver highly personalized aerobic and muscle-strengthening exercises remotely. By employing tools like Fitbit for activity tracking and resistance bands for strength training, the program makes it easy for participants to engage in physical activity from anywhere. Additionally, the emphasis on health education, goal setting, and self-monitoring through journaling aims to enhance both physiological and psychological well-being, providing a holistic approach to recovery.

What evidence suggests that this physical activity program is effective for cancer survivors?

Research shows that physical activity can improve the quality of life for cancer survivors. In this trial, participants will engage in a Social Cognitive Theory-based, technology-delivered physical activity program. Similar programs have increased activity levels and improved health outcomes. Specifically, the ENRICH trial found that these programs helped cancer survivors become more active. Personalized exercise plans can lead to better results by focusing on what works best for each person. These programs have improved various health aspects, including reducing inflammation and enhancing brain function, which are important for addressing "chemo-brain." Overall, evidence suggests that participating in a structured physical activity program benefits cancer survivors.23567

Who Is on the Research Team?

ZC

Zachary C Pope, PhD

Principal Investigator

University of Oklahoma Health Sciences

MK

Mikhail Kellawan, PhD

Principal Investigator

University of Oklahoma, Department of Health and Exercise Science

AY

Andriy Yabluchanskiy, MD, PhD

Principal Investigator

University of Oklahoma Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had non-CNS cancer treatment with chemotherapy in the last three years and are experiencing 'chemo-brain'. It includes those with Type 2 Diabetes (T2D) and without. Participants must speak/read English, give informed consent, own a smartphone/computer with internet, and be willing to join a 12-week remote physical activity program.

Inclusion Criteria

Ability to speak/read English
Ability to provide informed consent
Own smartphone and/or computer with internet access
See 4 more

Exclusion Criteria

Reporting a Physical Activity Readiness Questionnaire (2017 PAR-Q) score that indicates PA may potentially be unsafe, unless the participant produces a signed doctor's note
Engaging in ≥75 min/week of vigorous-intensity PA, ≥150 min/week of moderate-intensity PA, or an equivalent combination of both over the last 3 months
Currently a prisoner, pregnant, or planning to become pregnant during study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments of cerebrovascular, cognitive, pro-inflammatory, and cardiometabolic outcomes

1 week
1 visit (in-person)

Treatment

Participants engage in a 12-week technology-delivered physical activity program

12 weeks
Remote monitoring with periodic virtual check-ins

Follow-up

Participants are monitored for changes in health outcomes post-treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Social Cognitive Theory-based, Technology-delivered Physical Activity Program
Trial Overview The study tests a technology-delivered physical activity program based on Social Cognitive Theory to see if it improves brain vascular function, cognitive abilities, inflammation levels, cardiometabolic health, and psychosocial metrics in cancer survivors with or without T2D.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Social Cognitive Theory-based, Technology-delivered Physical Activity ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Published Research Related to This Trial

A pilot study showed that a physical activity behavior change intervention significantly improved physical activity levels and health outcomes among breast cancer survivors, indicating its potential effectiveness.
The upcoming two-site randomized controlled trial aims to recruit 256 breast cancer survivors to further assess the intervention's long-term effects and explore the mechanisms behind behavior change, with outcomes measured at multiple time points.
Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods.Rogers, LQ., McAuley, E., Anton, PM., et al.[2022]

Citations

Effect of a technology-supported physical activity ...This study reports psychosocial outcomes from a pilot randomized trial that used a novel approach – implementing a technology-based PA intervention as an add-on ...
Physical Activity Program for Cancer Survivors (CICI-PA Trial)Research shows that programs based on social cognitive theory (SCT) can help increase physical activity in cancer survivors. For example, the ENRICH trial found ...
Effects of personalized exercise prescriptions and social ...A systematic review and meta-analysis of social cognitive theory-based physical activity and/or nutrition behavior change interventions for cancer survivors.
Physical Activity Promotion for Breast and Endometrial ...Social Cognitive Theory (SCT) constructs : Exercise Self-Efficacy Scale. Self-efficacy will be assessed using the Exercise Self-Efficacy Scale which assess ...
A 10-Week Pilot Randomized TrialPhysical activity (PA) among breast cancer survivors (BCS) can improve this population's health and quality of life (QoL). This study evaluated the ...
Promoting physical activity among cancer survivorsElectronic, wearable health technology-based, BCTs, and theory-based interventions were effective and feasible in promoting physical activity in cancer ...
A Technology-Based Physical Activity Intervention for ...The Fit2ThriveMB trial is a two-arm pilot randomized controlled trial that will compare the effects of a smartphone-delivered, home-based PA intervention.
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