Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Fatigue

Sleepiness

Breast Diseases

Skin Diseases

Chronic Graft Versus Host Disease

Participants randomized into the standard of care group will be asked to continue following the instructions of the healthcare provider throughout the 10 week study period. They will not be asked to perform any study intervention.

In addition to their standard of care, participants will be asked to apply pressure on each of 9 acupressure points (bilaterally where indicated) that have been carefully selected for their relaxing effect. (There are 5 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 9 points to stimulate. Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes done once daily over a period of 6 weeks followed by 4 weeks of intervention wash-out where the participant will be asked to perform no acupressure at all.

In addition to their standard of care, participants will be asked to apply pressure on each of 9 acupressure points (bilaterally where indicated) that have been carefully selected for their excitatory effect. (There are 5 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 9 points to stimulate. There are 6 acupoints with 4 of the acupoints performed on both the left and the right sides of the body giving a total of 10 points to stimulate. Each of the 10 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 30 minutes done once daily over a period of 6 weeks followed by 4 weeks of intervention wash-out where the participant will be asked to perform no acupressure at all.

Apply pressure on 9 relaxatory acupressure points for 3 minutes each once daily for a 6 week period, followed by a 4 week wash-out period.

Relaxation Acupressure

Apply pressure on 10 excitatory acupressure points for 3 minutes each once daily for a 6 week period, followed by a 4 week wash-out period.

Stimulating Acupressure

Suzanna M Zick, ND, MPH

There are over 2 million breast cancer survivors today. Persistent Cancer-Related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by breast cancer (BC) survivors. Rates of significant PCRF in BC survivors range from 30% to 82% within the first 5-years of diagnosis and there are few treatment options for PCRF and these treatments require the availability of a trained practitioner, are associated with significant costs, pose a sizeable burden for the patient, or have unacceptable side-effects.

Acupressure is a technique derived from acupuncture, a component of Traditional Chinese Medicine. In acupressure, physical pressure is applied to acupuncture points by the hand, elbow, or with various devices to treat disease. Pilot studies have demonstrated that self-administered acupressure can significantly decrease PCRF by as much as 70% in cancer survivors. Acupressure can also have positive effects on sleep quality in cancer patients and other chronically ill populations. Self-administered acupressure is a non-toxic and inexpensive treatment that requires minimal instruction. It also requires little effort and time on the part of the patient to successfully complete. Thus, acupressure appears to be a promising treatment for PCRF and associated symptoms.

The investigators are conducting a single-blind, placebo controlled study to examine the specific effect of two opposing acupressure treatments compared to standard of care. The goal of this study is to determine the benefit of acupressure on treating persistent fatigue experience by many patients after completing their cancer treatment. Study patients will be randomized into one of three groups: two different types of acupressure or a standard of care arm. For those participants randomized to receive acupressure, the technique will be taught to them by a study nurse trained by an acupressure specialist. Participants will be asked to perform the acupressure daily over the next six weeks, during which time they will record their fatigue and be asked to wear an activity monitor to have their daily activity levels monitored.

Acupressure for Persistent Cancer Related Fatigue

Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors

National Cancer Institute (NCI)

University of Michigan

Research Associate Professor

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Endocrine System Diseases

Craniopharyngioma

Adamantinoma

Ameloblastoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Bone Neoplasms

Bone Diseases

Neuroepithelioma

The ecological momentary assessment (EMA) will be used for participants to complete surveys from home on two occasions each day over seven days.

Valerie Crabtree, PhD

Pediatric craniopharyngioma patients experience significant endocrine and sleep dysregulation difficulties. Sleep is a crucial part of children's healthy development, and sleep difficulties are associated with severe functional morbidity. Insufficient sleep, excessive daytime sleepiness, and poor sleep quality have all been significantly related to academic, behavioral, and emotional functioning in children and adolescents. Ecological momentary assessments (EMA) will be used to collect observational data.

EMA data will be collected twice daily for one week. For the morning EMA administration, participants will be asked about their sleep. During the evening administration, participants will be asked about their daytime sleepiness, overall well-being, and family functioning. Covariates also administered during the evening administration include medication administration (Y/N) and total screen time. At the end of the EMA data collection period (on day 7 OR 8), participants will be sent a survey asking them to report - anonymously - their overall experience and satisfaction with the EMA data collection method.

After recruitment and informed consent/assent is obtained for the current study, participants will be asked to complete a questionnaire battery online (via REDCap) assessing sleep habits, daytime sleepiness, family routines, family functioning, and overall quality of life in the past six months. The relationship between subjective sleep ratings obtained from the parent craniopharyngioma study at St. Jude (RT2CR) at diagnosis and 3 months later (T1 and T2) and family functioning/routines at the follow-up study (T3) will be assessed. The researchers have permission to use data for all participants who consent to participate in this follow-up EMA study.

Children will be sent electronic surveys two times per day (i.e., morning and evening) for seven days using Ilumivu software (https://ilumivu.com/mema-demo). Ilumivu is an established EMA tool that offers an in-mobile app for participants to respond to questionnaires in real time with limited burden. This application will send notifications to participants to remind them to complete surveys and record response times for each survey.

Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients

Examining Sleep and Family Functioning in Pediatric Craniopharyngioma Using Ecological Momentary Assessment

Study feasibility will be assessed by calculating the participation rate as follows: the number of participants who agree to participants divided by the number who are approached to participate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acupressure for Persistent Cancer Related Fatigue	NCT01281904	Chronic Fatigue Breast Cancer Sleepiness	Relaxation Acup... Stimulating Acu...	18 Years -	University of Michigan
Acupressure for Persistent Cancer Related Fatigue	NCT01281904	Chronic Fatigue Breast Cancer Sleepiness	Relaxation Acup... Stimulating Acu...	18 Years -	University of Michigan
Acupressure for Persistent Cancer Related Fatigue	NCT01281904	Chronic Fatigue Breast Cancer Sleepiness	Relaxation Acup... Stimulating Acu...	18 Years -	University of Michigan
Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients	NCT03330080	Craniopharyngio...		8 Years - 18 Years	St. Jude Children's Research Hospital
Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients	NCT03330080	Craniopharyngio...		8 Years - 18 Years	St. Jude Children's Research Hospital

Spots Global Cancer Trial Database for sleepiness

Every month we try and update this database with for sleepiness cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sleepiness

Every month we try and update this database with for sleepiness cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sleepiness cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.