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

Exercise Clinical Trial

— TEHEplus  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03576274
• Other study ID #: J1876
• Secondary ID: IRB00154198
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Nada Lukkahatai, PhD
• Phone: 410-614-5297
• Email: nada.lukkahatai[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acupressure
• Cancer-related Problem/Condition
• Exercise

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	The Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Johns Hopkins University, Oncology Nursing Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Fatigue will be measured by the self-report questionnaire including 1) the Functional Assessment of Cancer Therapy-Fatigue subscale (FACT-F), the 3-item fatigue scale with the total score range from 0 to 52 (high score mean low fatigue).	At baseline
Primary	Fatigue	Fatigue will be measured by the self-report questionnaire including 1) the Functional Assessment of Cancer Therapy-Fatigue subscale (FACT-F), the 3-item fatigue scale with the total score range from 0 to 52 (high score mean low fatigue).	At 6 weeks (study completion)
Secondary	Skeletal muscle strength	measured by the hand-held dynamometer	At baseline
Secondary	Skeletal muscle strength	measured by the hand-held dynamometer	Between Baseline and 6 weeks
Secondary	Heat Shock Protein level	Plasma level of Heat Shock Protein 90 measured in pg/ml	At baseline
Secondary	Heat Shock Protein level	Plasma level of Heat Shock Protein 90 measured in pg/ml	Between baseline and 6 weeks
Secondary	Brain Derived Neurotrophic Factors	Plasma level of Brain Derived Neurotrophic Factors measured in ng/ml	At baseline
Secondary	Brain Derived Neurotrophic Factors	Plasma level of Brain Derived Neurotrophic Factors measured in ng/ml	Between baseline and 6 weeks