Acupressure for Post-Treatment Cancer Fatigue - Tabular View

Tracking Information
First Received Date ^ICMJE	August 14, 2009
Last Updated Date	August 14, 2009
Start Date ^ICMJE	September 2007
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 14, 2009)	To examine the effect of two intensities of self-administered stimulating acupressure compared to self-administered relaxation acupressure on severity of chronic fatigue in people diagnosed with cancer who had completed all cancer therapies [ Time Frame: Once per week for 13 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: August 14, 2009)	Secondary objects were to evaluate the safety, tolerability, adherence, blinding and beliefs/expectation of participants of the three acupressure treatments [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Acupressure for Post-Treatment Cancer Fatigue
Official Title ^ICMJE
Brief Summary	Persistent cancer related fatigue (PCRF) is a common symptom experienced by many cancer survivors, which may last for as long as 10 years following treatment. PCRF is currently under diagnosed, with between 20% to >60% of survivors experiencing this symptom. Currently there are few effective treatment options for these patients. Acupressure offers a potential low-toxicity self-administered treatment option to treat PCRF. The investigators performed a pilot randomized single-blinded controlled trial of acupressure in cancer survivors experiencing moderate to severe PCRF. Potential participants were excluded if they had other causes of fatigue such as anemia, malnutrition, or chronic fatigue syndrome. Participants were randomized to one of three treatment groups: 1. relaxation acupressure (RA), 2. high intensity stimulatory acupressure (HIS), and 3. low intensity stimulatory acupressure (LIS). Participants performed acupressure for 12 weeks between 3 to 14 times per week depending on group. Fatigue was measured with the Brief Fatigue Inventory (BFI). Secondary outcomes included beliefs and expectations, assessment of blinding, compliance to treatment, demographics, and clinical parameters. The effect of group on BFI was assessed with ANOVA and linear regression. Correlations were also made between compliance and change in BFI.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Fatigue
Intervention ^ICMJE	Other: Self-administered Acupressure
Study Arms	Active Comparator: Relaxation acupressure Intervention: Other: Self-administered Acupressure Experimental: High Intensity Stimulating Acupressure Intervention: Other: Self-administered Acupressure Experimental: Low Intensity Stimulating Acupressure Intervention: Other: Self-administered Acupressure
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	43
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: People aged 18 years of age and older A diagnosis of cancer, except for squamous and basal cell carcinomas, who had completed their cancer-related treatments at least 12 weeks prior (except for on-going hormone therapy, which must have been initiated at least three weeks prior to enrollment To have a complaint of persistent, moderate to severe fatigue despite standard treatment [defined as > 4 on the Brief Fatigue Inventory (BFI)] To maintain their typical dietary patterns, especially the use of caffeinated beverages throughout the study, To be disease free and be acupuncture and acupressure naïve Exclusion Criteria: Diagnosed with anemia [defined as hemoglobin levels < 12 gm/dl] or receiving treatment for anemia Have any comorbidities likely to cause significant fatigue (i.e., moderate to severe heart failure, hypothyroidism) either currently or before cancer diagnosis Have problems with easy or spontaneous bruising from any cause, e.g. bleeding disorders Have nutritional deficiencies [defined by albumin levels < 35 g/liter] Have a diagnosis of depression and are not receiving active successful treatment for depression or have a HADS depression score of ≥ 11had a diagnosis of depression and are not receiving active successful treatment for depression or have a HADS depression score of ≥ 11 Have a thyroid disorder, defined as either thyroid stimulating hormone or free T4 lower than the normal range or greater than 2xs the upper range Have an anticipated survival rate of less than 6 months Have an initiation, a cessation or change of dose (up to three weeks prior to the study's start) of any chronic medications or dietary supplements or any planned change of chronic medications or dietary supplements during the study and are pregnant or lactating
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00959998
Other Study ID Numbers ^ICMJE	10915
Has Data Monitoring Committee	No
Responsible Party	Suzanna M. Zick, University of Michigan
Study Sponsor ^ICMJE	University of Michigan
Collaborators ^ICMJE	University of Michigan Cancer Center
Investigators ^ICMJE
Information Provided By	University of Michigan
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP