Cancer-related Problem/ConditionTEHEplusNCT03576274
Combined Technology Enhanced Home Exercise Program and Other Non-pharmacological Intervention for Cancer Survivors
A study testing Technology Enhanced Home Exercise (TEHE), Auricular Point Acupressure (APA) and Mindfulness body scan (MBI) in people with Cancer-related Problem/Condition and Exercise, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer-related Problem/Condition, Exercise, Acupressure
- What is being tested?
- Technology Enhanced Home Exercise (TEHE), Auricular Point Acupressure (APA) and Mindfulness body scan (MBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21205
About this study
Official title: Effectiveness of the Combined Technology-enhanced Home Exercise Program and Other Non-pharmacological Interventions on Fatigue, Physical Function and Well-being Among Cancer Survivors
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.
Read more
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.
Read the detailed description
Home-based exercise interventions have a significant effect on fatigue; however, motivation and intervention compliance are the main challenges. The use of personalized exercise and immediate feedback though smartphome communication has been found to increase motivation. We developed a 12 weeks technology enhanced home exercise (TEHE) program using mobile technologies that provide immediate feedback and sends reminder messages to improve exercise motivation. Moreover, to enhance the effectiveness of exercise, we combine this TEHE program with techniques--auricular point pressure and brief mindfulness body scan--, which have been found to affect fatigue and physical activities. The Auricular Point Acupressure (APA) and Mindfulness Based Intervention (MBI) may enhance the effect of exercise on fatigue; however, the feasibility and effectiveness of this combination have not been tested. This study will examine the feasibility of the TEHEplus program and ascertain the effect of TEHE program alone, APA alone, the TEHEplus program and the TEHE-MBI program on fatigue among cancer survivors and cancer patients receiving immunotherapy. In addition we will explore peripheral and central markers (e.g., Phosphorous levels) of cancer-related fatigue using magnetic resonance spectroscopy (MRS). This study will also investigate whether specific types of fatigue (e.g., physical fatigue, cognitive fatigue) will have different levels of these peripheral and central energy markers).
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.
- 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
- Cancer-related Problem/Condition, Exercise, Acupressure
- Being tested
- Technology Enhanced Home Exercise (TEHE), Auricular Point Acupressure (APA), Mindfulness body scan (MBI)
- Keywords
- Cancer related fatigue, Exercise, biomarkers, Auricular Point Acupressure
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology Enhanced Home Exercise (TEHE)Behavioural
A 12 week program including one 60-minute goal setting and exercise training program and follow up phone calls.
Auricular Point Acupressure (APA)Behavioural
A non invasive complementary method to provide pressure on the ear points.
Mindfulness body scan (MBI)Behavioural
The open, nonjudgmental attention to move one's attention calmly to the different part of the body
| Study group | Role | What they receive |
|---|---|---|
| Technology Enhanced Home Exercise only | Experimental | 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. Receives: Behavioral: Technology Enhanced Home Exercise (TEHE) |
| Technology Enhanced Home Exercise plus | Experimental | 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. Receives: Behavioral: Technology Enhanced Home Exercise (TEHE); Behavioral: Auricular Point Acupressure (APA) |
| Technology Enhanced Home Exercise-Mindfulness intervention | Experimental | 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. Receives: Behavioral: Technology Enhanced Home Exercise (TEHE); Behavioral: Mindfulness body scan (MBI) |
| Control (usual care) | No 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. |
| Auricular Point Acupressure only | Active comparator | 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. Receives: Behavioral: Auricular Point Acupressure (APA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue on the Patient-reported Outcomes Measure Information System (PROMIS-F) From Baseline to Week 12 (Post-intervention)
Fatigue will be measured by the self-report questionnaire including 1) the PROMIS-F, self self-report measure that assesses fatigue over the past 7 days. Score range 8-40 with higher score indicating worse fatigue.
Measured: Baseline and week 12 (post-intervention)
Secondary outcomes (4)
Change in Right-hand Skeletal Muscle Strength, Measured Using a Hand-held Dynamometer, From Baseline to Week 12 (Post-intervention)
Skeletal muscle strength was assessed by averaging the maximum force exerted across three trials for each hand using a hand-held dynamometer, with results recorded in pounds (lb).
Measured: Baseline and week 12 (post-intervention)
Change in Left-hand Skeletal Muscle Strength, Measured Using a Hand-held Dynamometer, From Baseline to Week 12 (Post-intervention)
Skeletal muscle strength was assessed by averaging the maximum force exerted across three trials for each hand using a hand-held dynamometer, with results recorded in pounds (lb).
Measured: Baseline and week 12 (Post-intervention)
Change in Brain Derived Neurotrophic Factors Between Baseline to Week 12 (Post-intervention)
Peripheral venous blood was collected in serum tubes for plasma BDNF analysis both before and after the intervention. Plasma level of Brain Derived Neurotrophic Factors measured in ug/ml
Measured: Between baseline and week 12 (post-intervention)
Change in Heat Shock Protein Level Measured in pg/ml From Baseline to Week 12 (Post-intervention)
Plasma level of Heat Shock Protein 90 (HSP90) measured in ug/ml from baseline to Week 12 (post-intervention)
Measured: Baseline and week 12 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start10 Oct 2019
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer-related Problem/ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Oncology Nursing Society
- Responsible party
- Sponsor
- Investigators
- Nada Lukkahatai, PhD, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576274
- Sponsor's protocol ID
- J1876
- Other IDs
- IRB00154198
- Acronym
- TEHEplus
- Status last verified
- Sep 2025
- First submitted
- 7 Jun 2018
- Last updated
- 10 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41034793
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Combined Technology-enhanced Home Exercise Program and Other Non-pharmacological Interventions on Fatigue, Physical Function and Well-being Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT03576274
- Acronym / sponsor ID
- TEHEplus / J1876
- Conditions
- Cancer-related Problem/Condition, Exercise, Acupressure
- Keywords
- Cancer related fatigue, Exercise, biomarkers, Auricular Point Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Oncology Nursing Society
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Posted 10 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Home-based exercise interventions have a significant effect on fatigue; however, motivation and intervention compliance are the main challenges. The use of personalized exercise and immediate feedback though smartphome communication has been found to increase motivation. We developed a 12 weeks technology enhanced home exercise (TEHE) program using mobile technologies that provide immediate feedback and sends reminder messages to improve exercise motivation. Moreover, to enhance the effectiveness of exercise, we combine this TEHE program with techniques--auricular point pressure and brief mindfulness body scan--, which have been found to affect fatigue and physical activities. The Auricular Point Acupressure (APA) and Mindfulness Based Intervention (MBI) may enhance the effect of exercise on fatigue; however, the feasibility and effectiveness of this combination have not been tested. This study will examine the feasibility of the TEHEplus program and ascertain the effect of TEHE program alone, APA alone, the TEHEplus program and the TEHE-MBI program on fatigue among cancer survivors and cancer patients receiving immunotherapy. In addition we will explore peripheral and central markers (e.g., Phosphorous levels) of cancer-related fatigue using magnetic resonance spectroscopy (MRS). This study will also investigate whether specific types of fatigue (e.g., physical fatigue, cognitive fatigue) will have different levels of these peripheral and central energy markers).
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Technology Enhanced Home Exercise only | Experimental | Behavioral: Technology Enhanced Home Exercise (TEHE)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 plus | Experimental | Behavioral: Technology Enhanced Home Exercise (TEHE), Behavioral: Auricular Point Acupressure (APA)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-Mindfulness intervention | Experimental | Behavioral: Technology Enhanced Home Exercise (TEHE), Behavioral: Mindfulness body scan (MBI)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. |
| Control (usual care) | No 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. |
| Auricular Point Acupressure only | Active comparator | Behavioral: Auricular Point Acupressure (APA)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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology Enhanced Home Exercise (TEHE)A 12 week program including one 60-minute goal setting and exercise training program and follow up phone calls. | Behavioural | Technology Enhanced Home Exercise only, Technology Enhanced Home Exercise plus, Technology Enhanced Home Exercise-Mindfulness intervention |
| Auricular Point Acupressure (APA)A non invasive complementary method to provide pressure on the ear points. | Behavioural | Auricular Point Acupressure only, Technology Enhanced Home Exercise plus |
| Mindfulness body scan (MBI)The open, nonjudgmental attention to move one's attention calmly to the different part of the body | Behavioural | Technology Enhanced Home Exercise-Mindfulness intervention |
Primary outcome
Change in Fatigue on the Patient-reported Outcomes Measure Information System (PROMIS-F) From Baseline to Week 12 (Post-intervention)
Time frame: Baseline and week 12 (post-intervention)
Fatigue will be measured by the self-report questionnaire including 1) the PROMIS-F, self self-report measure that assesses fatigue over the past 7 days. Score range 8-40 with higher score indicating worse fatigue.
4 secondary outcomes
Change in Right-hand Skeletal Muscle Strength, Measured Using a Hand-held Dynamometer, From Baseline to Week 12 (Post-intervention)
Time frame: Baseline and week 12 (post-intervention)
Change in Left-hand Skeletal Muscle Strength, Measured Using a Hand-held Dynamometer, From Baseline to Week 12 (Post-intervention)
Time frame: Baseline and week 12 (Post-intervention)
Change in Brain Derived Neurotrophic Factors Between Baseline to Week 12 (Post-intervention)
Time frame: Between baseline and week 12 (post-intervention)
Change in Heat Shock Protein Level Measured in pg/ml From Baseline to Week 12 (Post-intervention)
Time frame: Baseline and week 12 (post-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41034793Lukkahatai 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.
Related trials for Cancer-related Problem/Condition
Active, not recruiting
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Chronic Insomnia, Cancer-related Problem/Condition
RecruitingObservational study
Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care
Cardiovascular Complication, Cardiovascular Insufficiency
Not yet recruitingPhase 4
Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers and Mental Health.
Hepatitis B, Human Papilloma Virus
RecruitingPhase 1/2
Modafinil to Improve Fatiguability
Cancer-related Cognitive Difficulties, Cancer-related Problem/Condition
Active, not recruiting
Virtual Exercise Program to Reduce Cancer Related Fatigue
Cancer, Cancer-related Problem/Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nada Lukkahatai, PhD principal investigator
Johns Hopkins School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology Enhanced Home Exercise (TEHE), Auricular Point Acupressure (APA) and Mindfulness body scan (MBI) in people with Cancer-related Problem/Condition and Exercise, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue on the Patient-reported Outcomes Measure Information System (PROMIS-F) From Baseline to Week 12 (Post-intervention) (time frame: Baseline and week 12 (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03576274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.