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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-03772 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HUM00248915 | Other Identifier | University of Michigan Comprehensive Cancer Center |
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This clinical trial tests the feasibility of self-administered relaxing acupressure on fatigue in adolescent and young adult (AYA) cancer survivors. Acupressure, a type of complementary or alternative medicine, is the application of pressure or localized massage to specific sites on the body to control symptoms. Relaxing acupressure has been shown to improve cancer-related fatigue (CRF) in adults, however, less is known about the impact of relaxing acupressure on CRF in AYA cancer survivors."
PRIMARY OBJECTIVE:
I. Determine the feasibility of implementing a randomized controlled trial of a six-week, self-administered relaxing acupressure intervention in AYA cancer survivors with clinically relevant CRF.
SECONDARY OBJECTIVE:
I. Explore participants' perspectives of acceptability and satisfaction with the six-week acupressure interventions using semi-structured interviews.
EXPLORATORY OBJECTIVE:
I. Determine the preliminary efficacy of a six-week, virtual, self-administered relaxing acupressure intervention on clinically significant changes in CRF in post-treatment AYA cancer survivors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive access to an acupressure mobile application and self-administer relaxing acupressure to 9 acupoints over 27 minutes once daily (QD) for 6 weeks.
ARM II: Patients receive access to an acupressure mobile application and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks.
Enrollment was increased to 45.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM I (relaxing acupressure) | Experimental | Patients receive access to acupressure mobile application and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks. |
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| ARM II (sham acupressure) | Placebo Comparator | Patients receive access to acupressure mobile application and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure Therapy | Procedure | Self-administer relaxing acupressure |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Self-administered acupressure implementation will be feasible if all participants are recruited over 2 years. Descriptive statistics will be used to summarize recruitment rate. | 1 year |
| Number of Participants With Adherence | 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. | At 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Knoerl | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42337155 | Derived | Knoerl R, Jardine J, Chugh R, Fecher LA, Henry NL, Joquico M, Karimi Y, Ploutz-Snyder R, Taylor S, Walling E, Zick S. Determining the feasibility of self-administered relaxing acupressure for fatigue among adolescent and young adult cancer survivors. Support Care Cancer. 2026 Jun 24;34(7):684. doi: 10.1007/s00520-026-10917-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Intervention |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2025 |
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Patients are blinded to intervention.
| Acupressure Therapy | Procedure | Self-administer sham acupressure |
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| Internet-Based Intervention | Other | Receive access to acupressure mobile app |
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| Interview | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| baseline, 6 weeks, and 10 weeks after starting treatment |
| Acceptability E - Scale | 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 | 6 weeks after starting treatment |
| FG001 | 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 |
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| NOT COMPLETED |
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| Follow Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Rate | Self-administered acupressure implementation will be feasible if all participants are recruited over 2 years. Descriptive statistics will be used to summarize recruitment rate. | 42 participants occurred over approximately 12 months (October 1, 2024 to September 23, 2025) | Posted | Number | participants | 1 year |
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| Primary | Number of Participants With Adherence | 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. | Posted | Count of Participants | Participants | At 6 weeks |
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| Secondary | Change in Fatigue | 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. | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 6 weeks, and 10 weeks after starting treatment |
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| Secondary | Acceptability E - Scale | 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 | Acupressure arm: 7 lost to follow up; 3 discontinued interventions due to lack of time Sham: 1 patient lost to follow up | Posted | Median | Full Range | score on a scale | 6 weeks after starting treatment |
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Subjects were assessed over the 14 months that the study was active, and average of 40 days per subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | clinicaltrialsgov_ccadmin@med.umich.edu |
| Apr 14, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2025 | Apr 14, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D019050 | Acupressure |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Counts |
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| Participants |
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| 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 |
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| Units | Counts |
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| Participants |
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