Trial Outcomes & Findings for Combined Technology Enhanced Home Exercise Program and Other Non-pharmacological Intervention for Cancer Survivors (NCT NCT03576274)

NCT ID: NCT03576274

Last Updated: 2025-10-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

Baseline and week 12 (post-intervention)

Results posted on

2025-10-10

Participant Flow

Participants were recruited from Johns Hopkins-affiliated hospitals (Sibley Memorial, Bayview, and JHH) and via social media, co-investigator referrals, and JHU-ICTR MyChart messages. Flyers and bookmarks directed potential participants to a REDCap screening survey. Recruitment included clinical settings and online platforms. Participants were contacted by the PI or research staff.

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
22
23
21
22
22
Overall Study
COMPLETED
14
18
16
13
13
Overall Study
NOT COMPLETED
8
5
5
9
9

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Overall Study
Lost to Follow-up
3
2
3
1
3
Overall Study
Withdrawal by Subject
5
3
2
8
6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Technology Enhanced Home Exercise Plus
n=23 Participants
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 Only
n=22 Participants
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-Mindfulness Intervention
n=21 Participants
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)
n=22 Participants
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
n=22 Participants
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.
Total
n=110 Participants
Total of all reporting groups
Age, Continuous
61 years
STANDARD_DEVIATION 12 • n=7 Participants
59 years
STANDARD_DEVIATION 12 • n=5 Participants
61 years
STANDARD_DEVIATION 12 • n=5 Participants
60 years
STANDARD_DEVIATION 13 • n=4 Participants
58 years
STANDARD_DEVIATION 13 • n=21 Participants
60 years
STANDARD_DEVIATION 12 • n=8 Participants
Sex/Gender, Customized
Sex · Female
9 Participants
n=7 Participants
9 Participants
n=5 Participants
10 Participants
n=5 Participants
9 Participants
n=4 Participants
8 Participants
n=21 Participants
45 Participants
n=8 Participants
Sex/Gender, Customized
Sex · Male
14 Participants
n=7 Participants
12 Participants
n=5 Participants
11 Participants
n=5 Participants
13 Participants
n=4 Participants
14 Participants
n=21 Participants
64 Participants
n=8 Participants
Sex/Gender, Customized
Sex · Not reported
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
8 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
n=7 Participants
16 Participants
n=5 Participants
16 Participants
n=5 Participants
19 Participants
n=4 Participants
18 Participants
n=21 Participants
86 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants
n=7 Participants
4 Participants
n=5 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
16 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Asian
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
6 Participants
n=8 Participants
Race (NIH/OMB)
White
20 Participants
n=7 Participants
18 Participants
n=5 Participants
20 Participants
n=5 Participants
18 Participants
n=4 Participants
19 Participants
n=21 Participants
95 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
5 Participants
n=8 Participants
Education
High school and below
1 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
3 Participants
n=8 Participants
Education
Some college/associate degree
4 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=5 Participants
8 Participants
n=4 Participants
5 Participants
n=21 Participants
20 Participants
n=8 Participants
Education
Bachelor's degree or higher
18 Participants
n=7 Participants
19 Participants
n=5 Participants
18 Participants
n=5 Participants
11 Participants
n=4 Participants
15 Participants
n=21 Participants
81 Participants
n=8 Participants
Education
Not reported
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=5 Participants
3 Participants
n=4 Participants
2 Participants
n=21 Participants
6 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Baseline and week 12 (post-intervention)

Population: Participants with data collected at both baseline and post-intervention are reported.

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.

Outcome measures

Outcome measures
Measure
Technology Enhanced Home Exercise Only
n=14 Participants
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
n=18 Participants
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
n=16 Participants
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)
n=13 Participants
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
n=13 Participants
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.
Change in Fatigue on the Patient-reported Outcomes Measure Information System (PROMIS-F) From Baseline to Week 12 (Post-intervention)
-3.8 score on a scale
Standard Deviation 11.0
-7.9 score on a scale
Standard Deviation 19.8
-5.8 score on a scale
Standard Deviation 13.3
-3.2 score on a scale
Standard Deviation 9.2
-3.3 score on a scale
Standard Deviation 9.3

SECONDARY outcome

Timeframe: Baseline and week 12 (post-intervention)

Population: Participants with data collected at both baseline and post-intervention are reported.

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).

Outcome measures

Outcome measures
Measure
Technology Enhanced Home Exercise Only
n=3 Participants
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
n=10 Participants
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
n=3 Participants
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)
n=3 Participants
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
n=4 Participants
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.
Change in Right-hand Skeletal Muscle Strength, Measured Using a Hand-held Dynamometer, From Baseline to Week 12 (Post-intervention)
9.9 pounds (lb)
Standard Error 33.2
-2.5 pounds (lb)
Standard Error 10.2
2.8 pounds (lb)
Standard Error 2.1
-3.1 pounds (lb)
Standard Error 6.6
-0.4 pounds (lb)
Standard Error 3.6

SECONDARY outcome

Timeframe: Baseline and week 12 (Post-intervention)

Population: Participants with data collected at both baseline and post-intervention are reported.

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).

Outcome measures

Outcome measures
Measure
Technology Enhanced Home Exercise Only
n=3 Participants
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
n=10 Participants
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
n=3 Participants
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)
n=3 Participants
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
n=4 Participants
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.
Change in Left-hand Skeletal Muscle Strength, Measured Using a Hand-held Dynamometer, From Baseline to Week 12 (Post-intervention)
4.4 pounds (lb)
Standard Deviation 17.6
-0.7 pounds (lb)
Standard Deviation 12.0
3.0 pounds (lb)
Standard Deviation 1.3
-2.4 pounds (lb)
Standard Deviation 11.6
19.8 pounds (lb)
Standard Deviation 45.7

SECONDARY outcome

Timeframe: Between baseline and 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

Outcome measures

Outcome measures
Measure
Technology Enhanced Home Exercise Only
n=22 Participants
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
n=23 Participants
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
n=21 Participants
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)
n=22 Participants
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
n=22 Participants
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.
Change in Brain Derived Neurotrophic Factors Between Baseline to Week 12 (Post-intervention)
-4945.7 ug/ml
Standard Deviation 8777.9
-3971.3 ug/ml
Standard Deviation 9551.5
-106.5 ug/ml
Standard Deviation 1078.8
-2013.3 ug/ml
Standard Deviation 5807
-2912.8 ug/ml
Standard Deviation 13780

SECONDARY outcome

Timeframe: Baseline and week 12 (post-intervention)

Plasma level of Heat Shock Protein 90 (HSP90) measured in ug/ml from baseline to Week 12 (post-intervention)

Outcome measures

Outcome measures
Measure
Technology Enhanced Home Exercise Only
n=22 Participants
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
n=23 Participants
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
n=21 Participants
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)
n=22 Participants
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
n=22 Participants
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.
Change in Heat Shock Protein Level Measured in pg/ml From Baseline to Week 12 (Post-intervention)
-325.6 ug/ml
Standard Deviation 860.9
-106.5 ug/ml
Standard Deviation 1078.8
3.39 ug/ml
Standard Deviation 859.1
-297.0 ug/ml
Standard Deviation 753.1
-396.7 ug/ml
Standard Deviation 1465.3

Adverse Events

Technology Enhanced Home Exercise Only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Technology Enhanced Home Exercise Plus

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Technology Enhanced Home Exercise-Mindfulness Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control (Usual Care)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Auricular Point Acupressure Only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Technology Enhanced Home Exercise Only
n=22 participants at risk
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
n=23 participants at risk
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
n=21 participants at risk
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)
n=22 participants at risk
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
n=22 participants at risk
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.
Skin and subcutaneous tissue disorders
Wrist discomfort on the non-dominant wrist
0.00%
0/22 • Up to 12 weeks
4.3%
1/23 • Number of events 1 • Up to 12 weeks
0.00%
0/21 • Up to 12 weeks
0.00%
0/22 • Up to 12 weeks
0.00%
0/22 • Up to 12 weeks

Additional Information

Dr.Nada Lukkahatai,

Johns Hopkins School of Nursing

Phone: 410-614-5297

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place