Clinical trial NCT06442891: Self-Administered Relaxing Acupressure to Reduce Fatigue in Adolescent and Young Adult Cancer Survivors
Official title: A Pilot Study of Self-Administered Acupressure for Fatigue Among Adolescent and Young Adult (AYA) Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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 an AcuWand on study 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 an AcuWand and self-administer sham acupressure to non-acupressure point locations over 27 minutes QD for 6 weeks.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Up to 2 years
measure: Adherence
timeFrame: At 6 weeks
measure: Satisfaction
timeFrame: Up to week 10
measure: Change in fatigue
timeFrame: At baseline and up to week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Robert Knoerl
role: PRINCIPAL_INVESTIGATOR
References: