CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Technology Enhanced Home Exercise (TEHE) +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03576274
NCT03576274N/ACompleted

Effectiveness of the Combined Technology-enhanced Home Exercise Program and Other Non-pharmacological Interventions on Fatigue, Physical Function and Well-being Among Cancer Survivors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jul 3, 2018·Updated Oct 10, 2025

In Brief

A clinical study evaluating Technology Enhanced Home Exercise (TEHE), Auricular Point Acupressure (APA), and 1 other intervention for Cancer-related Problem/Condition and 2 related conditions. Completed, enrolled 110 participants across 1 site.

Detailed Summary

A 12 weeks technology enhanced home exercise (TEHE) program using mobile technologies that provide immediate feedback and send reminder messages to improve exercise motivation is developed. Investigators combine this TEHE program with techniques including auricular point pressure (APA) and brief mindfulness body scan (MBI). This study will examine the feasibility of the TEHE program and combined programs, and ascertain the effect of TEHE program alone, the combined programs on fatigue and biological markers among cancer survivors. Main Research Variable(s): The independent variables are the 12-week program of TEHE alone, APA alone, combined APA and TEHE (TEHEplus) and combined MBI and TEHE (TEHE-MBI). Outcome variables are fatigue, physical activity, contributing factors of fatigue and biomarkers. Design: Repeated measures randomized controlled trial. Setting: Participants will be recruited through the Comprehensive Cancer Center, Johns Hopkins University. Sample: Participants diagnosed with non-metastatic solid tumor cancer; who had completed all primary cancer treatment (surgery, chemotherapy, and radiation therapy )within at least 3 months OR non-metastatic prostate cancer completed all primary cancer treatment and have hormone therapy for at least 6 month, OR participants diagnosed with solid tumor cancer; who are receiving immunotherapy for at least 3 months before enrollment, aged 21 years or older, experiencing fatigue in the past 7 days on average of ≥ 3/10, able to participate in a moderate-intensity exercise training program, self-report ability to complete the 6 min walk test with a perceived exertion of 3 or below, and can communicate in English. Methods: Participants who meet the inclusion criteria will be randomly assigned to the TEHE only, APA only or TEHEplus or TEHE-MBI or control group. All exercise groups (TEHE) will be offered a 12-week exercise program through an online communication. In additional to the TEHE, the TEHEplus group will receive an instruction on how to apply the pressure on the ear points through online meeting/communication. The TEHE-MBI group will perform 5 min mindfulness body scan daily. The control (usual care) group will report participant's fatigue level daily. At the end of week 12, participants will answer open-ended questions about participant's opinions on the programs. Fatigue will be assessed and blood will be drawn before and after the program.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 3, 2018
Enrollment StartOct 10, 2019
Primary CompletionSep 15, 2024
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.0 years ago

Interventions

Technology Enhanced Home Exercise (TEHE)behavioral

A 12 week program including one 60-minute goal setting and exercise training program and follow up phone calls.

Auricular Point Acupressure (APA)behavioral

A non invasive complementary method to provide pressure on the ear points.

Mindfulness body scan (MBI)behavioral

The open, nonjudgmental attention to move one's attention calmly to the different part of the body