Behaviour Change for Cancer Survivors

(BOOST-Up Trial)

Recruiting at 1 trial location

Overseen By Emma V Tung, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Advanced cancer, Uncontrolled comorbidities, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

236 Participants Needed

Trial Summary

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 focuses on physical activity and exercise counseling for cancer survivors.

What data supports the effectiveness of the treatment Behaviour Change for Cancer Survivors?

Research shows that physical activity, combined with behavior change support, can improve health and wellbeing in cancer survivors, potentially reducing cancer recurrence and mortality. Interventions that include physical activity and behavior change strategies have been effective in helping cancer survivors maintain an active lifestyle, which is crucial for long-term health benefits. ^{1 2 3 4 5}

Is the Behaviour Change for Cancer Survivors program safe for humans?

The research articles do not provide specific safety data for the Behaviour Change for Cancer Survivors program, but they focus on increasing physical activity, which is generally considered safe and beneficial for cancer survivors when appropriately supervised. ^{2 3 6 7 8}

How is the Behaviour Change for Cancer Survivors treatment different from other treatments for cancer survivors?

The Behaviour Change for Cancer Survivors treatment is unique because it focuses on a virtual supervised physical activity program, which aims to help cancer survivors maintain long-term physical activity habits. This approach is different from traditional treatments as it emphasizes behavior change techniques and virtual support to encourage consistent exercise, which can improve health and reduce cancer recurrence. ^{1 2 4 9 10}

What is the purpose of this trial?

This study will be a two-arm, multi-site RCT, to examine the effects of an entirely virtual, 6-month supervised PA program plus standard exercise counselling (PA+EC) versus a supervised PA plus motivationally-enhanced behavioral counselling (PA+BC) on moderate to vigorous physical activity (MVPA) in cancer survivors. A 6-month post intervention follow-up (T2) and 1-year post intervention follow-up (T3; 1-year follow-up from post-intervention) will take place after the intervention to address maintenance. The intervention is designed using evidence-based research in the fields of exercise oncology using effective clinical design and theoretical approaches, including behaviour change techniques, to gradually increase MVPA to at least 90 minutes per week in cancer survivors as per the exercise guidelines for cancer survivors.

Research Team

Linda Trinh, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

This trial is for adults over 18 who've had cancer surgery at least 12 weeks ago, are in stages I-III of any cancer type, and finished radiation treatment at least 6 weeks prior. Participants should be physically inactive but able to walk with minimal aid, have internet access, speak English, and own a device capable of videoconferencing.

Inclusion Criteria

I am proficient in English.

My cancer is confirmed and is in stages I to III, not spread widely.

It has been at least 12 weeks since my last surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-month supervised physical activity program with either standard exercise counselling or motivationally-enhanced behavioural counselling

6 months

Bi-weekly virtual sessions

Follow-up

Participants are monitored for maintenance of physical activity levels post-intervention

6 months

Follow-up assessments at 6 months and 1 year post-intervention

Long-term Follow-up

Participants are further monitored for long-term adherence to physical activity guidelines

1 year

Treatment Details

Interventions

• Behaviour Change for Cancer Survivors

Trial Overview The study compares two programs: one combines standard exercise counseling with a virtual physical activity (PA) program; the other adds motivationally-enhanced behavioral counseling to PA. The goal is to increase moderate to vigorous physical activity in cancer survivors following evidence-based guidelines.

Participant Groups

Group I: Physical Activity + Behavioural Counselling (PA + BC) Experimental Treatment 1 Intervention

The PA+BC group will be given an individualized, home-based aerobic and resistance prescription based on baseline assessment and previous work. The participants will also receive behavioural counselling support sessions with a QEP every two weeks during the intervention period (12 total). The focus of these sessions will incorporate tailored behaviour change content from the M-PAC framework. At the end of the 6-month program, an individualized PA prescription will be provided based on their fitness level (adjusted throughout) to continue achieving the PA goal for the 6-month post intervention and 1-year post intervention follow-up.

Group II: Physical Activity + Exercise Couselling (PA + EC) Active Control 1 Intervention

The PA+EC group will be given an individualized, home-based aerobic and resistance prescription based on baseline assessment and previous work. The participants will also receive the same frequency of group-based and 1:1 counseling support sessions via Zoom as PA+BC participants. The focus of these sessions will be on exercise training principles for proper PA technique, how to monitor intensity, and progress PA safely to achieve the PA guidelines. The support sessions will be 30-45 minutes and delivered via Zoom each week in either group or 1:1 format depending on the topic.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Toronto Rehabilitation Institute

Collaborator

Trials

55

Recruited

6,000+

Findings from Research

A 6-month home-based physical activity intervention combined with counselling significantly increased physical activity levels and improved body mass and BMI in 80 breast cancer survivors compared to usual care.

Participants in the intervention group also experienced notable improvements in health-related quality of life and reductions in total cholesterol and LDL cholesterol, indicating both physical and psychological benefits from the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors. Lahart, IM., Metsios, GS., Nevill, AM., et al.[2022]

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 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]

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]

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]

In a pilot study involving 30 cancer patients, the use of a wearable activity tracker combined with personalized text message feedback led to 39% of participants increasing their daily steps by at least 20% over 3 months.

The intervention was well-received, with 72% of participants continuing to use the activity tracker at least 4 days a week after 6 months, suggesting it may effectively promote physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Koontz, BF., Levine, E., McSherry, F., et al.[2022]

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 MedEx IMPACT intervention was developed to help cancer survivors increase their physical activity levels, using insights from focus groups with 41 survivors and a thorough literature review.

This intervention is unique as it is the first to be designed using established frameworks like the Medical Research Council's guidelines, aiming to ensure its effectiveness and acceptability in promoting regular physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of the MedEx IMPACT Intervention: A Patient-Centered, Evidenced-Based and Theoretically-Informed Physical Activity Behavior Change Intervention for Individuals Living With and Beyond Cancer. Cantwell, M., Walsh, DMJ., Furlong, B., et al.[2021]

A systematic review of 27 studies found that demonstrating how to perform physical activity was the most commonly used behavior change technique (BCT) among interventions aimed at increasing activity levels in breast cancer survivors.

The use of objects like pedometers or accelerometers was identified as the BCT with the highest potential to boost physical activity, followed by goal setting and self-monitoring, highlighting effective strategies for future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of behaviour change techniques used in interventions to increase physical activity among breast cancer survivors. Hailey, V., Rojas-Garcia, A., Kassianos, AP.[2022]

Cancer survivors generally have low levels of physical activity but show a strong interest in increasing their participation in exercise programs, highlighting the potential for tailored interventions.

Adherence to physical activity programs varies based on demographic, medical, and behavioral factors, indicating that exercise programs should be customized to meet the specific needs of cancer survivors for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity among cancer survivors: a literature review. Szymlek-Gay, EA., Richards, R., Egan, R.[2011]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors. [2022]

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

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

3. 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]

4. 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]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). [2022]

7. 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]

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

The Development of the MedEx IMPACT Intervention: A Patient-Centered, Evidenced-Based and Theoretically-Informed Physical Activity Behavior Change Intervention for Individuals Living With and Beyond Cancer. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

A systematic review of behaviour change techniques used in interventions to increase physical activity among breast cancer survivors. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Physical activity among cancer survivors: a literature review. [2011]