NCT03655600

Brief Summary

This study seeks to determine the feasibility of recruiting and training participants in self-acupressure, for women undergoing primary breast cancer surgery or delayed reconstruction surgery. The study seeks to determine also if self-acupressure is effective in reducing the need for opioids post-surgery and the effects on other life factors.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

August 6, 2018

Last Update Submit

October 23, 2019

Conditions

Breast CancerFatigueChronic Pain

Outcome Measures

Primary Outcomes (3)

  • Feasibility of recruitment for self-acupressure: Measure screening to on-study ratio of participants

    Measure screening to on-study ratio of participants from Screening to Baseline

    14 days

  • Feasibility of training, as measured by number of participants who complete the daily self-reported logbook

    Measure the compliance of self-acupressure participants who are using the training application via daily self-reported logbook

    28 days

  • Feasibility of training for self-acupressure: Measure the fidelity (accuracy) of participants using training application via instrument administered by study team

    Measure the fidelity (accuracy) of participants using training application via instrument administered by study team

    1 day

Secondary Outcomes (2)

  • Pain mitigation in acute postoperative period measured using the Brief Pain Inventory

    2 weeks

  • Opioid use mitigation in acute postoperative period

    2 weeks

Study Arms (2)

Self-administered acupressure

ACTIVE COMPARATOR

Acupressure administered by participant self-taught from computer application

Other: Self-administered acupressure

Usual care

NO INTERVENTION

Usual care

Interventions

Self-administered acupressureOTHER

Self-administered acupressure learned through app for reduction of need for opioids post-surgery in breast cancer patients

Self-administered acupressure

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiological females only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of breast cancer stage 0 to III;
  • Planned unilateral or bilateral mastectomy or planned delayed breast reconstruction surgery within 24 months following unilateral or bilateral mastectomy;
  • For delayed breast reconstruction patients only: apparently cancer free at time of delayed reconstruction;
  • No planned new interventions for pain the two weeks prior to surgery;
  • Able to self-administer treatment at the specified points.

You may not qualify if:

  • Medically unstable (e.g. uncontrolled diabetes, high blood pressure, etc.);
  • For delayed breast reconstruction only: taking aromatase inhibitors which could confound surgical and chronic pain measurements;
  • Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder;
  • Unwilling to maintain stable does of allowed chronic pain medications (e.g. NSAIDS, benzodiazepines, SSRIs and SNRIs);
  • Pregnant, those planning a pregnancy, or lactating mothers;
  • Any medical condition or treatment factor that the study team feels would either compromise the data acquired or introduce a potential safety concern.
  • Unable to give consent;
  • Acupuncture or acupressure receipt in past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chronic Pain and Fatigue Research Center, University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsFatigueChronic Pain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic Manifestations

Study Officials

  • Suzanna M Zick, ND, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Richard E Harris, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized two arm (intervention and usual care) clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 31, 2018

Study Start

September 17, 2018

Primary Completion

October 17, 2019

Study Completion

October 17, 2019

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)