Lifestyle Intervention for Cancer Survivors

Overseen by Jennifer Bea, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arizona

Disqualifiers: Special diet, Weight loss, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a program to help Hispanic cancer survivors and their caregivers eat healthier and be more active. The goal is to reduce symptoms and improve overall health by providing support and boosting confidence.

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 data supports the effectiveness of the treatment Symptom Management and Lifestyle Intervention (SMLI) 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 survivors adjust to life after treatment. These findings suggest that SMLI could be beneficial for cancer survivors. ^{1 2 3 4 5}

Is the Lifestyle Intervention for Cancer Survivors safe for humans?

The research on lifestyle interventions for cancer survivors, including Symptom Management and Lifestyle Intervention (SMLI), suggests they are generally safe for humans, as they focus on improving nutrition, physical activity, and managing symptoms like fatigue and anxiety. ^{6 7 8 9 10}

How is the Symptom Management and Lifestyle Intervention (SMLI) treatment different from other treatments for cancer survivors?

The Symptom Management and Lifestyle Intervention (SMLI) is unique because it combines lifestyle changes, like diet and physical activity, with behavior change techniques to help manage symptoms and improve quality of life for cancer survivors. Unlike standard treatments that may focus solely on medical or pharmaceutical approaches, SMLI emphasizes comprehensive lifestyle modifications to address cancer-related fatigue and other chronic disease risk factors. ^{8 11 12 13 14}

Research Team

Jennifer Bea, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

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.

I am over 18, speak English or Spanish, have a phone, and am not being treated for cancer.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Symptom assessment only (Behavioral Intervention)
• Symptom management and lifestyle intervention (Behavioral 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.

Participant Groups

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+

Dr. Richard Carmona

University of Arizona

Chief Medical Officer since 2021

MD, University of Arizona

Dr. Evan Unger

University of Arizona

Chief Executive Officer since 2021

PhD in Medical Imaging, University of Arizona

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Dr. Larry Weiss

American Cancer Society, Inc.

Chief Medical Officer since 2016

MD from Duke University Medical Center

Dr. Wayne A. I. Frederick

American Cancer Society, Inc.

Chief Executive Officer

MD from Howard University, MBA from Howard University

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Scotland 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. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Lifestyle interventions are feasible in patients with colorectal cancer with potential short-term health benefits: a systematic review. [2023]

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

Self-Management Intervention for Adult Cancer Survivors After Treatment: A Systematic Review and Meta-Analysis. [2018]

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

Palliative Cancer Patients' Experiences of Participating in a Lifestyle Intervention Study While Receiving Chemotherapy. [2017]

5. Canada pubmed.ncbi.nlm.nih.gov

Evaluating the Feasibility of a Digital Therapeutic Program for Patients With Cancer During Active Treatment: Pre-Post Interventional Study. [2022]

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

Design and conduct of intervention-based research among cancer survivors. [2021]

7. Turkey pubmed.ncbi.nlm.nih.gov

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

8. Netherlands 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. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Self-management interventions for cancer survivors: a systematic review. [2019]

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

Lifestyle intervention for Latina cancer survivors and caregivers: the Nuestra Salud randomized pilot trial. [2022]

11. England 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. [2023]

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

Comprehensive Lifestyle Modification Intervention to Improve Chronic Disease Risk Factors and Quality of Life in Cancer Survivors. [2019]

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Diet and physical activity interventions in Black and Latina women with breast cancer: A scoping review. [2023]

14. Switzerland 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. [2023]