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Tech-Enhanced Exercise + Acupressure + Mindfulness for Cancer Fatigue Management (TEHEplus Trial)

N/A

Recruiting

Led By Nada Lukkahatai, PhD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 21 years or older, experiencing fatigue in the past 7 days with an average of ≥ 3/10

Diagnosed with non-metastatic prostate cancer and completed all primary cancer treatment and have hormone therapy for at least 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between baseline and 6 weeks

Awards & highlights

TEHEplus Trial Summary

This trial will examine the feasibility of a technology-enhanced home exercise (TEHE) program using mobile technologies to provide feedback and send reminder messages to improve motivation, combined with auricular point pressure (APA) and brief mindfulness body scan (MBI) to help cancer survivors manage fatigue.

Who is the study for?

This trial is for adult cancer survivors who've finished primary treatment at least 3 months ago, or have been on hormone therapy (for prostate cancer) or immunotherapy for over 6 months. They must be experiencing fatigue and able to do moderate exercise but can't join if they have active infections, major organ diseases, or severe psychological disorders.Check my eligibility

What is being tested?

The study tests a home exercise program enhanced by mobile tech reminders and feedback (TEHE), combined with ear point pressure (APA) and mindfulness body scans (MBI). It's a randomized trial to see how these methods affect fatigue and biological markers in cancer survivors over 12 weeks.See study design

What are the potential side effects?

Potential side effects are not explicitly mentioned but may include discomfort from acupressure, muscle soreness from exercise, and possible emotional responses to mindfulness practices.

TEHEplus Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 or older and have felt tired with a level of 3 out of 10 or more in the last week.

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I have prostate cancer, finished all initial treatments, and been on hormone therapy for 6+ months.

TEHEplus Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between baseline and 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between baseline and 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and between baseline and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fatigue

Secondary outcome measures

Brain Derived Neurotrophic Factors

Heat Shock Protein level

Skeletal muscle strength

TEHEplus Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Technology Enhanced Home Exercise-Mindfulness interventionExperimental Treatment2 Interventions

In addition to the TEHE program, the TEHE+MBI group will receive a audio-recording of a mindfulness-based body scan. During the weekly study visit: Participants will be instructed to listen to the recorded mindfulness-based body scan in the morning and before bedtime. At home: Participants will be asked to listen to this audiotape daily in the morning and before bedtime.

Group II: Technology Enhanced Home Exercise plusExperimental Treatment2 Interventions

In additional to the TEHE program, participants will receive auricular point acupressure (APA) training on how to locate the ear points, place the seeds and apply the pressure on the seed. Participants will be instructed to press the tape and seeds covering each ear point for 3 minutes per time with a 2-second pause in between pressing, three times daily (morning, afternoon and evening: 9 minutes total). The tape and seeds will remain on ear points for 5 days. Participants will be instructed to remove both at the end of the 5th day.

Group III: Technology Enhanced Home Exercise onlyExperimental Treatment1 Intervention

Participants in TEHE group will receive a combined technology and home exercise program. Participants will schedule an online meeting with the research team for exercise goal setting and preference. Participants will receive a daily symptoms survey. They will receive, reminder, motivation message and physical performance feedback though the mobile phone application.

Group IV: Control (usual care)Active Control1 Intervention

The control group will receive instructions on how to use the physical activity tracker and mEMA application. Participants will be asked to meet with a research team member weekly to discuss their fatigue experience and receive general information about fatigue management.

Group V: Auricular Point Acupressure onlyActive Control1 Intervention

Participants will receive auricular point acupressure (APA) training on how to locate the ear points, place the seeds and apply the pressure on the seed. Participants will be instructed to press the tape and seeds covering each ear point for 3 minutes per time with a 2-second pause in between pressing, three times daily (morning, afternoon and evening: 9 minutes total). The tape and seeds will remain on ear points for 5 days. Participants will be instructed to remove both at the end of the 5th day.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Oncology Nursing SocietyOTHER

10 Previous Clinical Trials

399 Total Patients Enrolled

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,820 Total Patients Enrolled

Johns Hopkins UniversityOTHER

2,265 Previous Clinical Trials

14,823,101 Total Patients Enrolled

Media Library

Auricular Point Acupressure (APA) Clinical Trial Eligibility Overview. Trial Name: NCT03576274 — N/A

Cancer Research Study Groups: Technology Enhanced Home Exercise-Mindfulness intervention, Control (usual care), Technology Enhanced Home Exercise only, Technology Enhanced Home Exercise plus, Auricular Point Acupressure only

Cancer Clinical Trial 2023: Auricular Point Acupressure (APA) Highlights & Side Effects. Trial Name: NCT03576274 — N/A

Auricular Point Acupressure (APA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03576274 — N/A

Frequently Asked Questions

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

To what extent has participation in the trial been maximized?

"Indeed, the information on clinicaltrials.gov reveals that this research endeavor is currently recruiting participants. The trial's first posting was made on October 10th 2019 and it most recently updated its data September 16th 2022. A total of 100 patients are needed at one medical facility to complete the study."

Answered by AI

Are there still openings for people to join this clinical investigation?

"Yes, the clinical trial is still ongoing. Data on clinicaltrials.gov confirms that this study was originally initiated on October 10th 2019 and most recently updated September 16th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combined Technology Enhanced Home Exercise Program and Other Non-pharmacological Intervention for Cancer Survivors

2019. "Combined Technology Enhanced Home Exercise Program and Other Non-pharmacological Intervention for Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03576274.