N/A
Completed N=110
Combined Technology Enhanced Home Exercise Program and Other Non-pharmacological Intervention for Cancer Survivors
Cancer-related Problem/Condition · Exercise · Acupressure
Source: ClinicalTrials.gov NCT03576274 ↗
Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Change in Fatigue on the Patient-reported Outcomes Measure Information System (PROMIS-F) From Baseline to Week 12 (Post-intervention) — -3.8; -7.9; -5.8; -3.2 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fatigue on the Patient-reported Outcomes Measure Information System (PROMIS-F) From Baseline to Week 12 (Post-intervention) |
-3.8; -7.9; -5.8; -3.2; -3.3 | — |
| SECONDARY Change in Right-hand Skeletal Muscle Strength, Measured Using a Hand-held Dynamometer, From Baseline to Week 12 (Post-intervention) |
9.9; -2.5; 2.8; -3.1; -0.4 | — |
| SECONDARY Change in Left-hand Skeletal Muscle Strength, Measured Using a Hand-held Dynamometer, From Baseline to Week 12 (Post-intervention) |
4.4; -0.7; 3.0; -2.4; 19.8 | — |
| SECONDARY Change in Brain Derived Neurotrophic Factors Between Baseline to Week 12 (Post-intervention) |
-4945.7; -3971.3; -106.5; -2013.3; -2912.8 | — |
| SECONDARY Change in Heat Shock Protein Level Measured in pg/ml From Baseline to Week 12 (Post-intervention) |
-325.6; -106.5; 3.39; -297.0; -396.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
- able to communicate in English.
Exclusion Criteria
- diagnosed with comorbidities, such as cardiovascular, lung, kidney, liver, or thyroid diseases
- have an active infection (e.g., fever, localized redness, swelling, sinus congestion)
- diagnosed with a psychological disorder (e.g., suicidal or homicidal tendencies, extreme anxiety or depression)
Data sourced from ClinicalTrials.gov (NCT03576274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.