Acupressure for Cancer-Related Fatigue
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|ClinicalTrials.gov Identifier: NCT03091647|
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: acupressure intervention Behavioral: usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Acupressure Intervention to Improve Fatigue and Physical Functioning of Chinese Immigrant Breast Cancer Survivors|
|Actual Study Start Date :||July 1, 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: acupressure intervention
Practice acupressure at home and complete daily logs
Behavioral: acupressure intervention
Women in the acupressure intervention group will learn how to press three chief energy acupoints on each side of the body through an 11-minute Chinese-language video and press three acupoints (1 minute per acupoint) on both sides of the body every day for a total of 6 minutes per day for an 8-week intervention period and record their practice on daily logs. Women will be asked to return the logs every week by email or self-addressed envelopes.
Placebo Comparator: usual care
Receive usual care and complete daily logs
Behavioral: usual care
Women in the usual care group will receive primary and oncology care from their doctors as usual, and complete daily logs recording their fatigue and daily functioning levels. They also need to return the logs every week by email or self-addressed envelopes.
- Cancer-related fatigue (proximal outcome) [ Time Frame: 8 weeks post-intervention ]The primary outcome will be measured by 6-item PROMIS (Patient-Reported Outcomes Measurement Information System) (e.g., felt tired, exhausted, limited at work).
- Physical functioning (distal outcomes) [ Time Frame: 8 weeks post-intervention ]The secondary outcomes will be measure by 8-item PROMIS (e.g., ability in carrying grocery, kneeling, climbing stairs).
- Sleep disturbance [ Time Frame: 8 weeks post-intervention ]The secondary outcomes will be measure by 6-item PROMIS (e.g., sleep not steady, unsatisfied, hard to fall asleep).
- Anxiety [ Time Frame: 8 weeks post-intervention ]The secondary outcomes will be measure by 7-item PROMIS (e.g., felt anxious, nervous, fearful, tense).
- Depression [ Time Frame: 8 weeks post-intervention ]The secondary outcomes will be measure by 8-item PROMIS (e.g., felt helpless, depressed, unhappy, hopeless).
- Pain interference [ Time Frame: 8 weeks post-intervention ]The secondary outcomes will be measure by 6-item PROMIS (e.g., affecting ability to focus, interact with others, run errands).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091647
|Contact: Judy Wang, Ph.D.||firstname.lastname@example.org|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|Contact: Judy Wang, PhD 202-687-6306 email@example.com|
|Principal Investigator:||Judy Wang, Ph.D.||Georgetown University|