Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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 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.
Interventions
PROCEDUREAcupressure Therapy
Self-administer relaxing acupressure
OTHERInternet-Based Intervention
Receive access to acupressure mobile app
OTHERInterview
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Patients are blinded to intervention.
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 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. |
| Number of Participants With Adherence | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue | 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. |
| Acceptability E - Scale | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Knoerl
University of Michigan Rogel Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.4 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 12 |
| other Total, other adverse events | 0 / 30 | 0 / 12 |
| serious Total, serious adverse events | 0 / 30 | 0 / 12 |
Outcome results
None listed