Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Symptoms and General Pathology

Anxiety Disorders

Breast Neoplasms

Parasomnias

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Women will undertake sessions of therapeutic massage

Women will undertake sessions of sham massage

Massage therapy involves the administration of combinations of specific physical manipulations applied in a systematic way, with varying intensity, direction, rate, and rhythm, to the soft tissues of the body.

Therapeutic massage

Sham massage involves only light touch massage in a non systematic way

Sham massage

Andreas Charalambous, PhD

This is a randomized control trial to test the effectiveness of therapeutic massage on the sleep quality and the stress levels in women that have completed their treatment for breast cancer.

The period following the completion of treatment for breast cancer (but also for any other type of cancer as well) is once that is accompanied by an increased uncertainty. This can often trigger increased anxiety levels and sleep disturbances. This trial tests the effectiveness of therapeutic massage as a non pharmaceutical intervention that can increase the management of stress and sleep disturbances during this period of time.

Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer

Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer: A Randomized Control Trial

Athens insomnia scale (The AIS is a self-assessment psychometric instrument designed for quantifying sleep difficulty based on the ICD-10 criteria. It consists of eight items: the first five pertain to sleep induction, awakenings during the night, final awakening, total sleep duration, and sleep quality; while the last three refer to well-being, functioning capacity, and sleepiness during the day). Each item of the AIS can be rated 0-3, (with 0 corresponding to no problem at all and 3 to very serious problem); thus, the total score ranges from 0 (absence of any sleep-related problem) to 24 (the most severe degree of insomnia).

Hamilton Anxiety Rating Scale (HAM-A). The scale consists of 14 items. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Cyprus Anticancer Society

Cyprus University of Technology

Associate Professor

Inflammation

Fatigue

Sleep Initiation and Maintenance Disorders

Breast Diseases

Skin Diseases

Sleep Disorders, Intrinsic

Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage

Therapeutic Massage

Judith G Myers, PhD

Anthony E Dragun, MD

Krystal S Angevine, MSW

A majority of women with breast cancer receive radiation therapy, and many of them experience the debilitating side effects of fatigue and insomnia. There is a need for an effective treatment that could ameliorate these symptoms and improve quality of life in the radiation therapy population.

The primary purpose of the proposed research is to study the impact of massage therapy as a tool for the management of fatigue and insomnia experienced by women diagnosed with breast cancer and receiving radiation therapy.

The secondary purpose is to explain, at the biochemical level, the effect of therapeutic massage on the level of fatigue and insomnia in radiation therapy patients. Prior studies have shown an association between fatigue and insomnia in the breast cancer patient following radiation therapy and the presence of inflammation as evidenced by increased proinflammatory cytokine production. The investigators hypothesize that therapeutic massage will ameliorate the symptoms of fatigue and insomnia associated with radiation therapy, and will be associated with a reduction in the plasma levels of interleukin-6 (IL-6),soluble IL-6 receptor (sIL-6R/CD126), and C-Reactive Protein (CRP). This reduction in proinflammatory biomarkers will be due to the activation of the cholinergic anti-inflammatory pathway via the activation of the vagus nerve.

The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy

Indiana University

Floyd Memorial Hospital and Health Services

Judith G. Myers, PhD

Wounds and Injuries

Heart and Blood Diseases

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Stroke

Heart Failure

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Sepsis

Toxemia

Quality of Life

Subject receives a 10-minute massage daily for three consecutive days

Subject receives a 20-minute massage daily for three consecutive days

The massage therapists were scheduled on a rotating schedule with two alternates scheduled for each day to ensure adherence to assigned study arm and to avoid "therapist effect" as much as possible. For each enrolled subject, the therapist assessed the subject and created a treatment plan depending on his/her individual needs and preferences. For example, if a subject reported bothersome lower extremity pain, the therapist might focus the massage on that lower extremity or might avoid massaging that lower extremity, depending solely on the preference of the subject. Massage duration was determined by the assigned study arm.

Therapeutic massage is the most common non-traditional treatment option offered to improve quality of life, provide comfort and decrease pain in hospice and palliative care settings outside the hospital. Three systematic reviews of data in general pain, surgical and cancer populations found massage to be effective for treating pain versus active comparators.

Given the remarkable negative impact on QOL experienced by patients hospitalized with a serious progressive illness, a nationwide opioid crisis in the setting of public concern for untreated pain, and patient demand for integrative therapies, we wish to investigate non-traditional methods of supporting patients in pain and providing clinicians with viable alternatives. Unfortunately, very little is known about optimal delivery of massage interventions in the hospital setting, including dosing parameters such as time and frequency

We conducted a single center comparative effectiveness study to evaluate therapeutic massage "dosing" to improve self-reported quality-of-life in hospitalized patients receiving palliative care consultation.

Palliative care (PC) provides expert symptom management and communication skills for patients and families facing serious life-limiting illness in the hospital. Many such patients experience lower quality of life (QOL) due to moderate-severe pain or other symptoms and require strong pharmacotherapies - often controlled substances such as opioids or benzodiazepines - to alleviate associated distress. A major tenet of quality supportive care is the combination of many types of therapy, both pharmacologic and nonpharmacologic. Patients with serious life-limiting illnesses often rely on the use of nonpharmacologic therapies to manage pain or other symptoms at home. However, implementing complementary therapies in the hospital setting can be challenging and thus they are rarely available for hospitalized patients with serious illness. Patients often request non-drug options, but medications remain the mainstay of treating pain while hospitalized.

Therapeutic massage is the most common non-traditional treatment option offered to improve quality of life, provide comfort and decrease pain in hospice and palliative care settings outside the hospital. Nevertheless, there remains limited data describing the impact of therapeutic massage in hospitalized patients receiving palliative care.

Additionally, in the hospital setting, the logistical challenges of providing massage therapy include a number of setting-specific factors. A massage therapy session may be interrupted by care being provided by other members of the team, by personal visitors, or by the activities of his/her roommate in a semi-private room. Also, the availability of massage therapy may be such that a patient's session time is limited because of the high demand on the short amount of time a non-integrated, contracted massage therapist has to see multiple patients. Given the remarkable negative impact on QOL experienced by patients hospitalized with a serious progressive illness, a nationwide opioid crisis in the setting of public concern for untreated pain, and patient demand for integrative therapies, we wish to investigate non-traditional methods of supporting patients in pain and providing clinicians with viable alternatives. Unfortunately, very little is known about optimal delivery of massage interventions in the hospital setting, including dosing parameters such as time and frequency.

The purpose of this study is to examine the impact of different massage dosing strategies on QOL, symptom management, and satisfaction in hospitalized patients already receiving PC consultation.

Study to Determine Therapeutic Massage Dosing to Improve Quality of Life in Hospitalized Patients Receiving Palliative Care

The McGill QOL Questionnaire is a validated reliable tool to evaluate self-reported QOL. One item in the Questionnaire has been shown to effectively assess subject's self-reported QOL.

The Edmonton Symptom Assessment Scale is a validated, reliable instrument developed to measure 9 different common symptoms in advanced illness

The NCCN Distress Thermometer is an 11-point Likert scale tool to self-report general distress between 0 (no distress) and 10 (extreme distress)

We adapted a single-item probe of spiritual concerns ("are you at peace?") to a 5-point Likert scale to self-report experience of being at peace, where 0=experiencing no peace and 5=experiencing total peace.

We developed a post-intervention Patient Satisfaction Survey that included pain-related questions from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, modified to reference the current hospitalization

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer	NCT03415230	Sleep Disturban... Anxiety	Therapeutic mas... Sham massage	18 Years - 60 Years	Cyprus University of Technology
The Clinical and Biochemical Effect of Therapeutic Massage on Fatigue and Insomnia in Women With Breast Cancer Receiving Radiation Therapy	NCT01071109	Breast Cancer Fatigue Insomnia	Therapeutic Mas...	18 Years -	Floyd Memorial Hospital and Health Services
Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer	NCT03415230	Sleep Disturban... Anxiety	Therapeutic mas... Sham massage	18 Years - 60 Years	Cyprus University of Technology
Study to Determine Therapeutic Massage Dosing to Improve Quality of Life in Hospitalized Patients Receiving Palliative Care	NCT04916223	Cancer Heart Failure COPD Sepsis HIV Infections ESRD Trauma Stroke	Therapeutic mas...	18 Years -	Medstar Health Research Institute

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