A Pilot Study of Self-Administered Acupressure for Fatigue Among Adolescent and Young Adult (AYA) Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Change in fatigue
Study Overview
Brief Summary
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."
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Masking Description
Patients are blinded to intervention.
Eligibility Criteria
- Ages
- 15 Years to 39 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Acupressure Therapy (Procedure)
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.
Intervention: Internet-Based Intervention (Other)
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.
Intervention: Interview (Other)
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.
Intervention: Medical Device Usage and Evaluation (Other)
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.
Intervention: Questionnaire Administration (Other)
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.
Intervention: Acupressure Therapy (Procedure)
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.
Intervention: Internet-Based Intervention (Other)
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.
Intervention: Interview (Other)
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.
Intervention: Medical Device Usage and Evaluation (Other)
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.
Intervention: Questionnaire Administration (Other)
Outcomes
Primary Outcomes
Change in fatigue
Time Frame: At baseline and up to week 10
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.
Recruitment rate
Time Frame: Up to 2 years
Self-administered acupressure implementation will be feasible if all participants are recruited over 2 years. Descriptive statistics will be used to summarize recruitment rate.
Satisfaction
Time Frame: Up to week 10
Interview data will be analyzed using inductive content analysis. Perspectives of the intervention will be analyzed using inductive content analysis.
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.
Secondary Outcomes
No secondary outcomes reported