CF Wellness Program Sessions for Fatigue

Phase-Based Estimates
Johns Hopkins University, Baltimore, MD
Fatigue+1 More
CF Wellness Program Sessions - Other
All Sexes
Eligible conditions

Study Summary

This study is evaluating whether a wellness program may help treat non-respiratory symptoms in people with cystic fibrosis.

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Eligible Conditions

  • Fatigue
  • Cystic Fibrosis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CF Wellness Program Sessions will improve 3 primary outcomes and 9 secondary outcomes in patients with Fatigue. Measurement will happen over the course of Day 0.

Week 13
Acceptability of the CF Wellness Program as assessed by the Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients
Feasibility of the CF Wellness Program as assessed by the Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients
Proportion of cognitive behavioral therapy (CBT) sessions completed
Proportion of weeks participant synced the fitness tracker watch to the Smartphone app
Qualitative interview as assessed by thematic analysis
Day 0
Proportion enrolled in the CF Wellness Program (CFWP)
Week 13
Change in exercise capacity as assessed by the 1 Minute Sit to Stand Test (1MSTST) test and Fitness tracker watch
Change in self-reported anxiety as assessed by the General Anxiety Disorder - 7 (GAD7) scale
Change in self-reported depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
Change in self-reported pain as assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity scale
Change self-reported sleep disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Mean change in fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue ( FACIT-F) Scale

Trial Safety

Trial Design

2 Treatment Groups

CF Wellness Program

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. CF Wellness Program Sessions 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.

CF Wellness Program
Participants will receive CF Wellness Program sessions.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to approximately 13 weeks post intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1 to approximately 13 weeks post intervention for reporting.

Closest Location

Johns Hopkins University - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Someone who has a smartphone, tablet, or computer with internet access. show original
is required You must be able to read, write, and speak English in order to do this job. show original
The participants in the study are not likely to start or change their modulator treatments during the intervention period. show original
Is considered to have significant fatigue The person has significant fatigue if they have a score of more than four on the Fatigue Severity Scale. show original
≥18 years old
is important to ensure that all members of the care team are aware of the diagnosis and implications for care show original
, and have a scan that indicates improvement in % predicted FEV1, then continue treatment If you are prescribed a modulator (like ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor, or elexacaftor/tezacaftor/ivacaftor), have been on treatment for at least 4 weeks, and your scan shows improvement in your % predicted FEV1, then continue treatment. show original
People prescribed medication for psychiatric purposes must be on treatment for at least 8 weeks. show original
Regular checkups and treatments at a CF center can help improve your quality of life if you have CF. 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.

What causes fatigue?

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Sleep deprivation, sleep debt, sleep quality, fatigue, psychosocial and other factors are intertwined with fatigue. There is growing evidence that sleep hygiene can mitigate fatigue.

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What are common treatments for fatigue?

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The most common treatment for fatigue is pain remedies (e.g., medication, or rest) as well as activity management. Other common treatments include cognitive-behavioral therapy, biofeedback, exercise, and relaxation techniques.\n

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

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About 19 million Americans are bothered by fatigue at least at least a few times a month, or about 1 in 20 US adults experience this debilitating symptom to some extent during a given month.

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What are the signs of fatigue?

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The symptoms of fatigue vary, and may vary across different populations. It is not always clear what causes symptoms such as weakness or low energy, and whether a symptom is due to fatigue. In one study of patients who suffer from fatigue, fatigue is said to be related to symptoms such as lethargy, reduced cognitive ability, and decreased general sense of wellbeing. Fatigue is also correlated with insomnia, headaches, physical pain, increased mood and anxiety. Other associated symptoms also include dizziness, weight loss, irritability, difficulty concentrating, and sleep disturbances including insomnia and night terrors.

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What is fatigue?

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The most common symptom of fatigue was 'exhaustion'. Fatigue is a subjective feeling of being tired and exhausted; it is often caused by excessive and sustained physical activity; however, it can also be caused by prolonged periods of rest. In the vast majority of cases, there is no underlying medical condition to blame; fatigue can be a symptom of low mood, low exercise level, sleep deprivation or sleep disorder, chronic illness or illness. On a more formal level, fatigue is experienced by almost half of the global populace who are suffering from chronic fatigue syndrome.

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Can fatigue be cured?

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Results from a recent clinical trial supports the feasibility of a multi-disciplinary approach to addressing fatigue from the perspectives of patients, caregivers, health professionals and industry.

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What is the average age someone gets fatigue?

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Average age of fatigue onset was 38 years old (mean +/- SEM = 40.4 +/- 3.0 yr, range = 32.2-45.4 yr) in this retrospective multicenter study based on 1,092 patients from multiple centers recruited from a single country. Although the average person gets fatigue at 40 years of age, it was observed as early as age 24 (10.8%) and as late as age 83 (9.5%). Older individuals might benefit from treatments, such as sleep supplements, or the enhancement of nutrition.

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Does fatigue run in families?

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The findings of the present review provide evidence for familial clustering of many fatigue-related characteristics. However, the specific characteristics of these familial clusters are largely debatable because of the lack of a sufficiently large sample size, the lack of control sequences, and possible selection, ascertainment bias, and population heterogeneity.

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What are the common side effects of cf wellness program sessions?

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Most common side effects included nausea, abdominal pain, and increased fatigue. Symptoms were not more severe than for any other period of therapy. Exercise should be performed at least once daily. Exercise during treatment may improve symptoms.

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Does cf wellness program sessions improve quality of life for those with fatigue?

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The inclusion of participants in the Cf wellness program resulted in a trend to improved QoL in the total sample and in the subgroups of women and of those with moderate-to-severe fatigue. In addition, at the end of the 6-months follow-up, the subgroup of those with moderate-to-severe fatigue and controls had the greatest improvement in the subscales for fatigue and, presumably, in quality of life (physical and mental) when compared with the other samples.

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Is cf wellness program sessions typically used in combination with any other treatments?

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The findings suggest that when patients complete the Cf program (either alone or in combination with one or more treatments), there are no clinically-important changes in fatigue, quality of life, overall functioning, or treatment outcomes (primary or secondary prevention) one year following program completion. Additional research on clinical and cost effectiveness of Cf programs is warranted.

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What is cf wellness program sessions?

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A comprehensive, 12-session, low-income weight maintenance workshop and support program with individualized follow-up sessions can reduce and prevent weight loss and fat accumulation over an 18-month period.

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