Combined Technology Enhanced Home Exercise Program and Other Non-pharmacological Intervention for Cancer Survivors
NCT ID: NCT03576274
Last Updated: 2025-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2019-10-10
2024-09-15
Brief Summary
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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.
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Detailed Description
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Conceptual Framework: The biopsychosocial model will be used. 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 (depressive symptom, anxiety, sleep, relationship with others), and biomarkers.
Design: Repeated measures randomized controlled trial design. 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, TEHEplus or TEHE-MBI or control (usual care) group. All exercise groups will be offered a 12-week exercise program. The program will based on personal exercise preference and physical activity goals to reach moderate intensity based on readings from a heart rate monitor and exertion level. Activity/steps will be monitored daily using the FitBit Charge. Reminders to exercise will be sent to the patient through a mobile phone application based on the participants' personal schedule and frequency. In additional to the TEHE, the APA only, and the TEHEplus group will receive an instruction on how to apply the pressure on the ear points through the online meeting and mobile application. The TEHE-MBI group will perform 5 min of mindfulness body daily. The control (usual care) group will report their fatigue level daily and attend weekly meetings with the researcher to discuss fatigue. At the end of week 12, in addition to the questionnaires, participants will answer open-ended questions about their opinions on the program. Fatigue will be assessed and blood will be drawn before and after the program. Participants who enrolled in the sub-study will be scheduled for a visit for an MRS before the exercise intervention.
2\. Objectives (include all primary and secondary objectives)
Purpose/Specific Aims:
The study primary aims are to (1) test the feasibility of a 12-week technology-enhanced home exercise (TEHE) program and combined technology-enhanced home exercise and Auricular Point Acupressure (TEHE plus) program among cancer survivors; (2) to determine the effect of the TEHE plus program on fatigue, physical activity and serum biomarkers (Heat Shock Protein 90 and Brain-Derived Neurotrophic Factor) compared to the control (usual care) group.
The secondary aims are to (3) compare the effect of the TEHE only, TEHE plus, APA only, combined MBI and TEHE on fatigue and physical activity; and (4) determine the change in serum biomarkers at week 12 compared to baseline in the TEHE only, TEHE plus, APA only, MBI+TEHE, and control (usual care) groups (5) explore the associations of muscle and brain energetic markers using magnetic resonance spectroscopy (MRS) with fatigue symptoms of cancer survivors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Technology Enhanced Home Exercise only
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.
Technology Enhanced Home Exercise (TEHE)
A 12 week program including one 60-minute goal setting and exercise training program and follow up phone calls.
Technology Enhanced Home Exercise plus
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.
Technology Enhanced Home Exercise (TEHE)
A 12 week program including one 60-minute goal setting and exercise training program and follow up phone calls.
Auricular Point Acupressure (APA)
A non invasive complementary method to provide pressure on the ear points.
Technology Enhanced Home Exercise-Mindfulness intervention
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.
Technology Enhanced Home Exercise (TEHE)
A 12 week program including one 60-minute goal setting and exercise training program and follow up phone calls.
Mindfulness body scan (MBI)
The open, nonjudgmental attention to move one's attention calmly to the different part of the body
Control (usual care)
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.
No interventions assigned to this group
Auricular Point Acupressure only
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.
Auricular Point Acupressure (APA)
A non invasive complementary method to provide pressure on the ear points.
Interventions
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Technology Enhanced Home Exercise (TEHE)
A 12 week program including one 60-minute goal setting and exercise training program and follow up phone calls.
Auricular Point Acupressure (APA)
A non invasive complementary method to provide pressure on the ear points.
Mindfulness body scan (MBI)
The open, nonjudgmental attention to move one's attention calmly to the different part of the body
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
21 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Oncology Nursing Society
OTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Nada Lukkahatai, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Nursing
Locations
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The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Countries
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References
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Lukkahatai N, Benjasirisan C, Shen A, Li J, Allgood S, Thomas F, Karyukin A, Sheng JY, Engle J, Lee TY, Saligan LN. Combined technology-enhanced home exercise and acupressure (TEHEplus) program on symptoms among cancer patients receiving immunotherapy: a feasibility study. BMC Cancer. 2025 Oct 1;25(1):1481. doi: 10.1186/s12885-025-14887-2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00154198
Identifier Type: OTHER
Identifier Source: secondary_id
J1876
Identifier Type: -
Identifier Source: org_study_id
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