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NCT06442891 | RECRUITING | Hematopoietic and Lymphatic System Neoplasm

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

University of Michigan Rogel Cancer Center

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."

Condition or disease

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Intervention/treatment

Acupressure Therapy

Acupressure Therapy

Internet-Based Intervention

Interview

Medical Device Usage and Evaluation

Questionnaire Administration

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : SINGLE
Masking Description : Patients are blinded to intervention.
Primary Purpose : SUPPORTIVE_CARE
Official Title : A Pilot Study of Self-Administered Acupressure for Fatigue Among Adolescent and Young Adult (AYA) Cancer Survivors
Actual Study Start Date : 2024-10-01
Estimated Primary Completion Date : 2026-12-01
Estimated Study Completion Date : 2026-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 15 Years to 39 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Self-Administered Relaxing Acupressure to Reduce Fatigue in Adolescent and Young Adult Cancer Survivors

Location Details

NCT06442891

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Locations

RECRUITING

United States, Road cancer

University of Michigan Comprehensive Cancer Center

Ann Arbor, Road cancer, United States, 48109