Full SYNC app for Fatigue

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Michigan Rogel Cancer Center, Ann Arbor, MI
Fatigue+5 More
Full SYNC app - Other
Eligibility
18+
All Sexes
Eligible conditions
Fatigue

Study Summary

This study is evaluating whether a mobile app can help reduce fatigue for cancer patients.

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Eligible Conditions

  • Fatigue
  • Hematologic Neoplasms
  • Breast Cancer
  • Prostate Cancer
  • Survival Rate (Survivorship)
  • Malignancies, Hematologic

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Full SYNC app will improve 1 primary outcome and 5 secondary outcomes in patients with Fatigue. Measurement will happen over the course of baseline, weekly to 12 weeks.

baseline to 12 weeks
Change in level of anxiety using PROMIS SF Anxiety 7a
Change in level of depression using PROMIS SF Depression 8a
Change in level of physical function using PROMIS SF Physical Function 8b
Change in level of sleep disturbance using PROMIS SF Sleep Disturbance 8a
Change in overall health metrics using PROMIS Global-10
Week 12
Change in fatigue assessed with Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a

Trial Safety

Trial Design

2 Treatment Groups

Control Arm
Intervention Arm

This trial requires 138 total participants across 2 different treatment groups

This trial involves 2 different treatments. Full SYNC App is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention ArmLight intervention delivered through SYNC app + blue-light blocking glasses.
Control ArmPlacebo light intervention delivered through SYNC app + clear glasses.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 12 weeks for reporting.

Closest Location

University of Michigan Rogel Cancer Center - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A response of at least 4 on a 10 point scale (with 0 = not fatigued at all and 10 = extremely fatigued) to the question "How fatigued did you feel in the past week?"
The breast cancer population is made up of women who were diagnosed with stage 1-3 breast cancer in the last 10 years, and who do not have metastatic disease show original
The autologous HSCT population consists of participants who are from the University of Michigan Blood and Marrow Transplant Program. show original
To be eligible for the study, participants must own an iPhone 6s or later and be willing to complete surveys on it. show original
The patient must have been taking the sleep aid for at least four weeks prior to enrollment and agree to continue taking the same dose during the study in order to be allowed to use the sleep aid. show original
Men who have prostate cancer and are undergoing androgen deprivation therapy for at least three months and are expected to remain on androgen deprivation therapy for the duration of the trial are eligible for this study show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can fatigue be cured?

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There is no curative treatment for fatigue. Treatment options should focus on the improvement of symptoms related to fatigue. The therapeutic effects of fatigue treatments need to be evaluated and standardized.

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What are common treatments for fatigue?

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Some common treatments for fatigue such as sleep hygiene measures, physical activity, and relaxation may relieve fatigue, but this article focuses only on treatments that have evidence based effects and may work better for patients.

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What is fatigue?

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For nearly a century, there has been uncertainty about the cause of mild or chronic fatigue. To date, there remains controversy as to whether the cause of chronic fatigue is a psychiatric or a physical condition. In more severe cases, the symptoms of chronic fatigue may be related to the physiological functioning of the endocrine system, including the HPA axis. In the acute phases of major illnesses, chronic fatigue may be the primary presentation of a medical illness. Although chronic fatigue syndrome (CFS) was first described in the 1970s, there is disagreement on the underlying physiology of CFS including its pathophysiology, neurobiology, pharmacology and genomics. There is a lack of high-quality clinical trials to validate drug treatments.

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What causes fatigue?

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People often complain of feeling tired, and many physicians ask themselves and patients how much they are working, how much they are physically demanding of their activities, and what causes fatigue. Although some doctors have documented fatigue as a symptom of more serious disorders such as cancers such as breast cancer, more and more individuals are seeking advice from physicians to explore their own feeling of fatigue. Many physicians now feel the need to know how the fatigue relates and why it may be happening because fatigue can be bothersome to those experiencing it, to their spouse and/or caregiver, and to their employer.

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How many people get fatigue a year in the United States?

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The current prevalence estimate is 20% per year, or about 40 million Americans every year. In a subgroup of patients with comorbidities, the prevalence of fatigue is about 33% per year. Furthermore, a subgroup of patients with chronic fatigue syndrome has a prevalence of fatigue of almost 85% per year. This subgroup would constitute about 7.5 million to 8.5 million people in the United States every year.

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What are the signs of fatigue?

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Fatigue is a common symptoms in patients with leukemia that may be attributed to hematologic disease. Physicians should be informed and should strive and offer appropriate treatment for fatigue.

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What is the survival rate for fatigue?

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As in the past, fatigue is difficult to treat and often results in severe morbidity and disability among cancer patients. It has been observed that fatigue can have a negative health effect and that fatigue is one of the main reasons for premature death in cancer patients. Data from a recent study has shown that fatigue can be classified into 4 types: physical fatigue, emotional/mental fatigue, decreased quality of life, and decreased function. Physical fatigue correlates strongly with psychological fatigue which may be more closely related to depression and anxiety symptoms. Therefore, prevention and intervention strategies should consider the use of cognitive-behavioural therapy or mindfulness exercises to prevent physical fatigue from developing into psychological fatigue. The present study found that fatigue could not be measured without considering subjective reporting.

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How serious can fatigue be?

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The seriousness of fatigue has been underestimated in patients. Fatigue can be a very serious issue that should be discussed and examined at an early stage with an experienced physiatrist. Patients want information about fatigue because it is the most common reason they mention for avoiding physical movement. There are many types of fatigue and the types and level of seriousness will differ depending on the source of fatigue. The serious sources of fatigue are fatigue as a symptom from [diseases, drugs, traumatic], and from physical activity. Most cases have been reported in people who had severe diseases such as [cancer, anemia, arthritis, multiple sclerosis, Parkinson's disease, HIV, and AIDS] and had a long disease duration before fatiguing.

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Is full sync app safe for people?

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Results from this study indicate that sync as a form of technology is a viable means of achieving healthy weight with sustained levels of activity with a lower-than-expected likelihood for adverse events.

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What does full sync app usually treat?

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Findings from a recent study suggested that, full sync app improves sleepiness especially post-lunch drowsiness and it may be a useful treatment to reduce fatigue in the afternoon and evening.

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What are the common side effects of full sync app?

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There are many side effects of full sync app. It is crucial to make a self-study for different side effects every time a patient uses full sync app. The side effects can vary by each user and depend on each user's condition(s). It is also crucial that patients know if they have been exposed to the full sync app for long or short period before it begins. In particular, patients should read about the full sync app as it helps them to identify the side effects from full sync app. As well, it is critical to tell a doctor when a patient has experienced side effects(s), and if not, the doctor should ask for detailed information.

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Have there been any new discoveries for treating fatigue?

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Fatigue can be treated, and most people with fatigue are able to continue with their lives, by using a variety of strategies. The American Academy of Family Physicians has suggested a recommendation for treating mild fatigue. They recommend checking with your doctor about medication options, and the Mayo Clinic recommends checking with your doctor about treatments to help reduce the impact of fatigue. If medication is prescribed, a common prescription is cyclobenzaprine. Physicians at the Mayo Clinic also recommend using a number of dietary supplements such as vitamins, Co-Q10, and L-carnitine, and using massage, meditation, relaxation techniques, and rest.

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