Trial Outcomes & Findings for Self-Administered Relaxing Acupressure to Reduce Fatigue in Adolescent and Young Adult Cancer Survivors (NCT NCT06442891)

NCT ID: NCT06442891

Last Updated: 2026-06-23

Results Overview

Self-administered acupressure implementation will be feasible if all participants are recruited over 2 years. Descriptive statistics will be used to summarize recruitment rate.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

1 year

Results posted on

2026-06-23

Participant Flow

Participant milestones

Participant milestones
Measure
ARM I (Relaxing Acupressure)
Patients received access to acupressure mobile application and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer relaxing acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
ARM II (Sham Acupressure)
Patients received access to acupressure mobile application and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer sham acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
Intervention
STARTED
30
12
Intervention
COMPLETED
30
12
Intervention
NOT COMPLETED
0
0
Follow Up
STARTED
30
12
Follow Up
COMPLETED
20
11
Follow Up
NOT COMPLETED
10
1

Reasons for withdrawal

Reasons for withdrawal
Measure
ARM I (Relaxing Acupressure)
Patients received access to acupressure mobile application and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer relaxing acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
ARM II (Sham Acupressure)
Patients received access to acupressure mobile application and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer sham acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
Follow Up
Lost to Follow-up
7
1
Follow Up
Lack of time
3
0

Baseline Characteristics

Self-Administered Relaxing Acupressure to Reduce Fatigue in Adolescent and Young Adult Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ARM I (Relaxing Acupressure)
n=30 Participants
Patients received access to acupressure mobile application and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer relaxing acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
ARM II (Sham Acupressure)
n=12 Participants
Patients received access to acupressure mobile application and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer sham acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
Total
n=42 Participants
Total of all reporting groups
Age, Continuous
31.6 years
STANDARD_DEVIATION 6.5 • n=20 Participants
29.4 years
STANDARD_DEVIATION 8.0 • n=20 Participants
31.0 years
STANDARD_DEVIATION 6.9 • n=40 Participants
Sex: Female, Male
Female
24 Participants
n=20 Participants
10 Participants
n=20 Participants
34 Participants
n=40 Participants
Sex: Female, Male
Male
6 Participants
n=20 Participants
2 Participants
n=20 Participants
8 Participants
n=40 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=20 Participants
2 Participants
n=20 Participants
3 Participants
n=40 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants
n=20 Participants
10 Participants
n=20 Participants
39 Participants
n=40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Asian
4 Participants
n=20 Participants
0 Participants
n=20 Participants
4 Participants
n=40 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=20 Participants
1 Participants
n=20 Participants
1 Participants
n=40 Participants
Race (NIH/OMB)
White
25 Participants
n=20 Participants
11 Participants
n=20 Participants
36 Participants
n=40 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=20 Participants
0 Participants
n=20 Participants
1 Participants
n=40 Participants
Region of Enrollment
United States
30 participants
n=20 Participants
12 participants
n=20 Participants
42 participants
n=40 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 42 participants occurred over approximately 12 months (October 1, 2024 to September 23, 2025)

Self-administered acupressure implementation will be feasible if all participants are recruited over 2 years. Descriptive statistics will be used to summarize recruitment rate.

Outcome measures

Outcome measures
Measure
ARM I (Relaxing Acupressure)
n=30 Participants
Patients received access to acupressure mobile application and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer relaxing acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
ARM II (Sham Acupressure)
n=12 Participants
Patients received access to acupressure mobile application and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer sham acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
Recruitment Rate
30 participants
12 participants

PRIMARY outcome

Timeframe: At 6 weeks

Self-administered acupressure implementation will be feasible if 60% of participants complete the baseline and 6-week patient-reported measures and if 60% of acupressure group participants self-report acupressure practice for at least 27 minutes on at least 3 days per week. Descriptive statistics will be used to summarize adherence.

Outcome measures

Outcome measures
Measure
ARM I (Relaxing Acupressure)
n=30 Participants
Patients received access to acupressure mobile application and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer relaxing acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
ARM II (Sham Acupressure)
n=12 Participants
Patients received access to acupressure mobile application and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer sham acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
Number of Participants With Adherence
11 Participants
5 Participants

SECONDARY outcome

Timeframe: baseline, 6 weeks, and 10 weeks after starting treatment

Population: Acupressure arm: 7 lost to follow up; 3 discontinued interventions due to lack of time Sham: 1 patient lost to follow up, and 2 did not complete the questionnaire

Measured using the Patient Reported Outcomes Measurement Information Systems Fatigue 4a questionnaire. Results are continuously scaled and appropriately analyzed by Gaussian-based statistical models. Change in fatigue will be analyzed using a Full Information Maximum Likelihood mixed-effects linear regression model. Specifically, change from baseline will be evaluated by including fixed-effects coefficients for time, treatment, and the important interaction effects that will determine whether changes from baseline are greater in the relaxing acupressure group, relative to controls. Random Y-intercepts in the model will be incorporated to accommodate the nesting of repeated observations within subject. Change in fatigue will be analyzed using a Full Information Maximum Likelihood mixed-effects linear regression model. Range score is 30-80 and increasing scores indicate worse symptoms.

Outcome measures

Outcome measures
Measure
ARM I (Relaxing Acupressure)
n=30 Participants
Patients received access to acupressure mobile application and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer relaxing acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
ARM II (Sham Acupressure)
n=12 Participants
Patients received access to acupressure mobile application and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer sham acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
Change in Fatigue
6 Weeks
49.99 score on a scale
Interval 46.89 to 53.1
54.62 score on a scale
Interval 50.36 to 58.87
Change in Fatigue
10 Weeks
50.73 score on a scale
Interval 47.63 to 53.84
54.45 score on a scale
Interval 49.82 to 59.08
Change in Fatigue
Baseline
60.11 score on a scale
Interval 57.52 to 62.7
62.69 score on a scale
Interval 58.6 to 66.79

SECONDARY outcome

Timeframe: 6 weeks after starting treatment

Population: Acupressure arm: 7 lost to follow up; 3 discontinued interventions due to lack of time Sham: 1 patient lost to follow up

Interview data will be analyzed using inductive content analysis. Perspectives of the intervention will be analyzed using inductive content analysis. (1 - 5, higher scores = greater acceptability) from the Acceptability E-Scale (Tariman et al., 2011) applies to all rows listed

Outcome measures

Outcome measures
Measure
ARM I (Relaxing Acupressure)
n=20 Participants
Patients received access to acupressure mobile application and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer relaxing acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
ARM II (Sham Acupressure)
n=11 Participants
Patients received access to acupressure mobile application and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks. Acupressure Therapy: Self-administer sham acupressure Internet-Based Intervention: Receive access to acupressure mobile app Interview: Ancillary studies Questionnaire Administration: Ancillary studies
Acceptability E - Scale
How easy was it for you to practice self-administered acupressure during the study?
4 score on a scale
Interval 1.0 to 5.0
4 score on a scale
Interval 2.0 to 5.0
Acceptability E - Scale
How understandable was the content presented in the acupressure app?
5 score on a scale
Interval 3.0 to 5.0
5 score on a scale
Interval 4.0 to 5.0
Acceptability E - Scale
How much did you enjoy practicing self-administered acupressure?
3 score on a scale
Interval 1.0 to 5.0
3 score on a scale
Interval 1.0 to 5.0
Acceptability E - Scale
How helpful was self-administered acupressure in managing fatigue?
3 score on a scale
Interval 1.0 to 5.0
2 score on a scale
Interval 1.0 to 5.0
Acceptability E - Scale
Was the frequency (daily) of the self-administered acupressure intervention acceptable?
3.5 score on a scale
Interval 1.0 to 5.0
3 score on a scale
Interval 2.0 to 5.0
Acceptability E - Scale
Was the length (27 min) of each self-administered acupressure session acceptable?
3 score on a scale
Interval 1.0 to 5.0
3 score on a scale
Interval 2.0 to 4.0
Acceptability E - Scale
Overall, how would you rate your satisfaction with the self-administered acupressure intervention?
3 score on a scale
Interval 1.0 to 5.0
3 score on a scale
Interval 2.0 to 4.0

Adverse Events

ARM I (Relaxing Acupressure)

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

ARM II (Sham Acupressure)

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin

University of Michigan Rogel Cancer Center

Phone: 734-936-9499

Results disclosure agreements

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