- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06442891
Self-Administered Relaxing Acupressure to Reduce Fatigue in Adolescent and Young Adult Cancer Survivors
A Pilot Study of Self-Administered Acupressure for Fatigue Among Adolescent and Young Adult (AYA) Cancer Survivors
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University Of Michigan Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 15 - 39 years old
- At least three months post cancer treatment (e.g., surgery, radiation or chemotherapy). Participants receiving maintenance hormonal or targeted therapies will be allowed to enroll as determined by the study investigator
- Report clinically relevant fatigue in the past seven days (Patient Reported Outcomes Measurement Information Systems [PROMIS] Fatigue 4a scores ≥ 55)
- Speak / read English
- CRF started at or after the diagnosis of cancer
- Completed cancer treatment within the past five years
Exclusion Criteria:
- Diagnosis of untreated anemia, mood disorder, or hypothyroidism
- Plan to begin new pharmacological, psychological, or other treatments (i.e., physical therapy or dietary supplements) for CRF during the study. Although, participants may continue usual treatments for CRF if the treatments were initiated at least eight weeks prior to study enrollment, and the dose has not changed
- Plan to become pregnant or lactating during the study period
- Received acupressure or acupuncture in the past year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ARM I (relaxing acupressure)
Patients receive access to acupressure mobile application and self-administer relaxing acupressure to 9 acupoints over 27 minutes QD for 6 weeks.
|
Ancillary studies
Ancillary studies
Self-administer relaxing acupressure
Other Names:
Self-administer sham acupressure
Other Names:
Receive access to acupressure mobile app
|
|
Placebo Comparator: ARM II (sham acupressure)
Patients receive access to acupressure mobile application and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks.
|
Ancillary studies
Ancillary studies
Self-administer relaxing acupressure
Other Names:
Self-administer sham acupressure
Other Names:
Receive access to acupressure mobile app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Rate
Time Frame: 1 year
|
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
Time Frame: 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.
|
At 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fatigue
Time Frame: baseline, 6 weeks, and 10 weeks after starting treatment
|
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.
|
baseline, 6 weeks, and 10 weeks after starting treatment
|
|
Acceptability E - Scale
Time Frame: 6 weeks after starting treatment
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robert Knoerl, University of Michigan Rogel Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Therapeutics
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Interviews as Topic
- Acupressure
Other Study ID Numbers
- UMCC 2024.016
- NCI-2024-03772 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- HUM00248915 (Other Identifier: University of Michigan Comprehensive Cancer Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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