Lifestyle Intervention for Cancer Survivors

Overseen By Samantha Werts, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Special diet, Weight loss, others

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

217 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to support Hispanic female cancer survivors in adopting healthier lifestyle habits to improve overall well-being and reduce lingering symptoms such as pain, sleep issues, or fatigue. Participants receive weekly coaching sessions, educational materials, and tools like a pedometer to help manage symptoms and stay active. This approach is part of the Symptom Management and Lifestyle Intervention (SMLI) program. The study seeks Hispanic female cancer survivors who have experienced common cancer-related symptoms and completed their main cancer treatment within the past ten years. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that can enhance symptom management strategies 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, it mentions that participants should not have any cancer treatments planned, except for maintenance therapy like hormonal therapy.

What prior data suggests that this lifestyle intervention is safe for cancer survivors?

Research has shown that lifestyle changes, such as the Symptom Management and Lifestyle Intervention (SMLI), are generally safe for cancer survivors. Studies have found that these changes can enhance quality of life without major safety concerns. Exercise, for instance, is well-studied and aids in cancer recovery. Reports of harmful effects from these lifestyle changes are insignificant. These programs emphasize better eating, increased physical activity, and symptom management, all considered safe. Most participants adapt well to these changes, making them a safe option for many cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lifestyle intervention for cancer survivors because it offers a comprehensive approach to managing symptoms and improving quality of life. Unlike typical treatments that focus solely on medication, this intervention combines personalized coaching sessions, educational materials, and self-monitoring tools like a pedometer, promoting active patient engagement. This method empowers survivors to take control of their health through lifestyle changes, which could potentially lead to better long-term outcomes than standard care options alone.

What evidence suggests that this symptom management and lifestyle intervention is effective for improving health in Hispanic cancer survivors?

Research has shown that lifestyle changes, such as improving diet and increasing physical activity, can significantly enhance the well-being of cancer survivors. For Hispanic cancer survivors, adopting healthier habits can reduce ongoing symptoms and improve overall quality of life. In this trial, some participants will receive a Symptom Management and Lifestyle Intervention, which includes 12 weekly telephone-based coaching sessions, a participant educational handbook, and a pedometer for self-monitoring physical activity. Studies have found that self-care programs help breast cancer patients manage their symptoms more effectively. A review of multiple studies indicates that healthy lifestyle changes can enhance the quality of life for cancer survivors. This approach aims to help survivors adhere to nutrition and exercise guidelines, boosting their long-term health. ^{1 2 4 6 7}

Who Is on the Research Team?

Jennifer Bea, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for Hispanic cancer survivors over 18 who've finished treatment within the last year, except hormonal therapy or trastuzumab. They must have a caregiver to join with them and suffer from symptoms like pain or fatigue rated at least 4 out of 10 in severity. Participants need phone access and must understand English or Spanish.

Inclusion Criteria

I am a Hispanic female cancer survivor, over 18, with a caregiver, and have had severe cancer symptoms.

Exclusion Criteria

I am under 18, finished cancer treatment over a year ago, and have a caregiver willing to join.

I am a caregiver under 18, without phone access, not in diet counseling or cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weekly telephone-based coaching sessions and educational materials for symptom management and lifestyle intervention

12 weeks

12 visits (virtual)

Follow-up

Participants are monitored for sustainability of the intervention and outcomes such as fruit and vegetable intake and physical activity

12 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Symptom assessment only
• Symptom management and lifestyle intervention

Trial Overview The study compares two approaches: one group will only assess their symptoms, while the other will also receive guidance on symptom management and lifestyle changes aimed at meeting nutrition and physical activity guidelines to improve health and reduce cancer risk.

How Is the Trial Designed?

Group I: Symptom management and lifestyle intervention Experimental Treatment 1 Intervention

Dyads will receive 12 weekly telephone-based coaching sessions, a participant educational handbook, and a pedometer for self-monitoring physical activity.

Group II: Attention control Active Control 1 Intervention

Dyads will receive mailed print education materials regarding healthy lifestyle (nutrition and physical activity) disseminated by ACS and NCI. They will also receive 12 weekly phone calls to assess post-treatment related symptoms.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

A comprehensive lifestyle intervention called Lifestyle 180® led to significant health improvements in 58 cancer survivors over 12 months, including an average weight loss of 14 pounds and reductions in waist circumference and BMI, indicating effective weight management.

Participants also experienced notable improvements in biomarkers related to chronic disease risk, such as decreased triglycerides and fasting insulin levels, along with enhanced quality of life and reduced perceived stress, supporting the importance of lifestyle changes in cancer survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Lifestyle Modification Intervention to Improve Chronic Disease Risk Factors and Quality of Life in Cancer Survivors. Golubić, M., Schneeberger, D., Kirkpatrick, K., et al.[2019]

The 6-month LEAN Self-Guided lifestyle intervention resulted in a significant average weight loss of 1.3 kg for breast cancer survivors compared to a waitlist group, indicating its efficacy in promoting healthy weight management.

This low-resource intervention, which utilized printed materials and online videos, also showed potential improvements in physical activity, diet quality, and fatigue, suggesting it could be effectively integrated into various healthcare settings for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial Evaluating a Self-Guided Lifestyle Intervention Delivered via Evidence-Based Materials versus a Waitlist Group on Changes in Body Weight, Diet Quality, Physical Activity, and Quality of Life among Breast Cancer Survivors. Puklin, LS., Harrigan, M., Cartmel, B., et al.[2023]

Self-management interventions (SMIs) can help improve health-related quality of life (HRQoL) in breast cancer survivors, particularly in physical and functional well-being, based on a review of nine randomized controlled trials.

While SMIs show potential effectiveness, the improvements in HRQoL are generally small and inconsistent, indicating a need for more rigorous testing and development of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective are self-management interventions in promoting health-related quality of life in people after primary treatment for breast cancer? A critical evidence synthesis. Cheng, L., Kotronoulas, G.[2020]

Intervention trials are crucial for understanding how lifestyle changes can positively impact cancer survivors' health, but there is a need for better study design and reporting to ensure high-quality data.

Most trials have not explored varying doses or long-term interventions, highlighting the necessity for longer-duration studies that align with real-world clinical practices to enhance outcomes for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and conduct of intervention-based research among cancer survivors. Wolin, KY., Colditz, GA.[2021]

A systematic review of 29 randomized controlled trials found that 17 were effective in reducing cancer-related fatigue among survivors, with key behavior change techniques (BCTs) like goal setting and instruction on how to perform behaviors being frequently used.

The BCT 'Generalisation of the target behaviour' was identified as promising for helping cancer survivors incorporate lifestyle changes into their daily lives, but there is a need for more studies focusing on dietary behaviors and including follow-up assessments to evaluate long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviour change techniques used in lifestyle interventions that aim to reduce cancer-related fatigue in cancer survivors: a systematic review. de Vries-Ten Have, J., Winkels, RM., Kampman, E., et al.[2023]

Self-management interventions (SMIs) significantly improved health-related quality of life (HRQOL) for cancer survivors after treatment, based on a meta-analysis of 9 randomized controlled trials involving 2,804 participants.

While SMIs showed a large effect on reducing fatigue, the impacts on anxiety, depression, and self-efficacy were not statistically significant, indicating the need for further research to optimize SMI formats and delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management Intervention for Adult Cancer Survivors After Treatment: A Systematic Review and Meta-Analysis. Kim, SH., Kim, K., Mayer, DK.[2018]

A 4-week trial involving 30 cancer patients showed that a digital therapeutic program delivered via a smartphone app was highly engaging, with 97% of participants active for at least 3 weeks and an average of 7.7 interactions per day.

Participants reported high satisfaction with the program, with 89% likely to recommend it, and while quality of life remained stable, 50% experienced less pain, indicating potential benefits of lifestyle interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Feasibility of a Digital Therapeutic Program for Patients With Cancer During Active Treatment: Pre-Post Interventional Study. Gudmundsson, GH., Mészáros, J., Björnsdóttir, ÁE., et al.[2022]

A randomized controlled trial involving 80 women with breast cancer showed that a 24-week lifestyle intervention program, including dietary training and aerobic exercises, significantly reduced fatigue and body mass index (BMI) while improving quality of life (QoL) and sleep quality compared to a control group.

The results suggest that lifestyle interventions can serve as an effective non-pharmacologic therapy to help manage physical and psychological symptoms in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Lifestyle Interventions in Breast Cancer Women after Completion of Primary Therapy: A Randomized Study. Ghavami, H., Akyolcu, N.[2022]

The integrated symptom management and lifestyle intervention (SMLI) was found to be feasible and highly acceptable among 45 dyads of Latina cancer survivors and their caregivers, with a 63% consent rate and 98% acceptance.

The intervention led to significant improvements in dietary habits and physical activity among survivors, including increased fruit and vegetable intake and reduced sugar consumption, as well as a notable reduction in symptom burden, indicating its potential effectiveness in promoting adherence to cancer prevention guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention for Latina cancer survivors and caregivers: the Nuestra Salud randomized pilot trial. Crane, TE., Badger, TA., O'Connor, P., et al.[2022]

Self-management interventions for cancer survivors can lead to significant improvements in areas like fatigue, physical functioning, and self-efficacy, as shown in three of the six studies reviewed.

However, the benefits of these interventions were not consistently maintained over time, indicating a need for more sustainable self-management strategies that can be integrated into daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management interventions for cancer survivors: a systematic review. Boland, L., Bennett, K., Connolly, D.[2019]

This systematic review analyzed 11 randomized controlled trials (RCTs) focused on theory-based lifestyle interventions for weight loss in breast cancer survivors, finding that 7 of these trials were classified as 'very promising' in their effectiveness to reduce body weight by at least 5%.

The most commonly used theoretical framework was Social Cognitive Theory, and all interventions included key behavioral change techniques such as goal setting and self-monitoring, which are crucial for successful weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying the effective behaviour change techniques in nutrition and physical activity interventions for the treatment of overweight/obesity in post-treatment breast cancer survivors: a systematic review. Perperidi, M., Saliari, D., Christakis, C., et al.[2023]

A scoping review of 22 randomized controlled trials focused on diet and physical activity interventions for breast cancer survivors revealed that most studies were pilot or feasibility trials, highlighting a significant need for larger efficacy trials specifically targeting Black and Latina women.

Culturally tailored approaches in interventions, which included elements like traditional foods and bicultural health coaches, were limited but showed promise in improving outcomes, indicating that future studies should prioritize these aspects to better serve these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and physical activity interventions in Black and Latina women with breast cancer: A scoping review. Pichardo, MS., Sanft, T., Ferrucci, LM., et al.[2023]

Lifestyle interventions, particularly physical activity and dietary changes, are feasible for colorectal cancer (CRC) patients and can lead to short-term health improvements, including better dietary quality and enhanced quality of life.

One study indicated that dietary interventions may significantly improve long-term cancer-specific survival, highlighting the potential for lifestyle changes to have lasting benefits for CRC survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle interventions are feasible in patients with colorectal cancer with potential short-term health benefits: a systematic review. Moug, SJ., Bryce, A., Mutrie, N., et al.[2023]

Palliative cancer patients value participation in lifestyle interventions, which can help them adopt healthier habits, take a more active role in their care, and boost their confidence while undergoing chemotherapy.

However, some participants experienced feelings of guilt for not meeting their lifestyle goals, highlighting the need for careful organization of these interventions to avoid adding stress to patients already coping with serious illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Cancer Patients' Experiences of Participating in a Lifestyle Intervention Study While Receiving Chemotherapy. Mikkelsen, HE., Brovold, KV., Berntsen, S., et al.[2017]

Citations

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SMLI With Hispanic Cancer Survivors and Caregivers Healthier lifestyle behaviors (such as diet and physical activity) would result in an immediate benefit of reduced symptoms and long-term benefit of improved ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12257549/

Lifestyle intervention for Latina cancer survivors and ... The primary outcomes of the trial were diet and physical activity, and secondary outcomes were severity of symptoms and self-efficacy for ...

3. withpower.com withpower.com/trial/phase-malignancies-4-2022-43c0f

Lifestyle Intervention for Cancer Survivors Research shows that lifestyle interventions can improve symptoms and quality of life for cancer patients, and self-management interventions help breast cancer ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388923001382

Effects of digital self-management symptom interventions ... In this study, we aimed to evaluate the effectiveness of digital SM symptom interventions on symptom outcomes in adult cancer patients.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12081566/

A meta-analysis of healthy lifestyle interventions addressing ... Several meta-analyses have evaluated the efficacy of healthy lifestyle interventions in enhancing QoL in cancer survivors, but their results have been ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10777971/

Characteristics and Components of Self-Management ... Self-management interventions showed promise for improving the quality of life in cancer survivors; however, caution is required because the intervention ...

7. research.aota.org research.aota.org/ajot/article/71/2/7102100030p1/6304/Systematic-Review-of-Occupational-Therapy-and

Part 1. Impact of Physical Activity and Symptom Management ... The area of exercise is the best researched and has the most robust outcomes in terms of cancer survivorship and cancer rehabilitation, but the ...