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

NCT03576274 | Completed Results DMC

• 2 other identifiers: J1876IRB00154198
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer-related Problem/Condition; Exercise; Acupressure

Keywords

Cancer related fatigue; Exercise; biomarkers; Auricular Point Acupressure

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  Baseline and week 12 (Post-intervention)

• Change in Brain Derived Neurotrophic Factors Between Baseline to Week 12 (Post-intervention)

  Between baseline and week 12 (post-intervention)

• Change in Heat Shock Protein Level Measured in pg/ml From Baseline to Week 12 (Post-intervention)

  Baseline and week 12 (post-intervention)

Study Arms (5)

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.

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.

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.

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.

Behavioral: Auricular Point Acupressure (APA)

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.

Technology Enhanced Home Exercise only; Technology Enhanced Home Exercise plus; Technology Enhanced Home Exercise-Mindfulness intervention

Auricular Point Acupressure (APA) BEHAVIORAL

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

Auricular Point Acupressure only; Technology Enhanced Home Exercise plus

Mindfulness body scan (MBI) BEHAVIORAL

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

Technology Enhanced Home Exercise-Mindfulness intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Johns Hopkins University: collaborator
• Oncology Nursing Society: collaborator

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 41034793 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

The study's limitations include a small sample size and low statistical power, as it was designed as a pilot to assess feasibility rather than detect statistically significant effects.

Results Point of Contact

• Title: Dr.Nada Lukkahatai,
• Organization: Johns Hopkins School of Nursing

nada.lukkahatai@jhu.edu

410-614-5297

Study Officials

• Nada Lukkahatai, PhD

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: July 3, 2018
• Study Start: October 10, 2019
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: October 10, 2025
• Results First Posted: October 10, 2025

Record last verified: 2025-09

Locations

US (1)