Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Reflexology Sessions: One session per week performed by certified reflexologist for four consecutive weeks.

Placebo Sessions: One session per week performed by research aide for four consecutive weeks.

One session per week performed by certified reflexologist for four consecutive weeks.

Reflexology Sessions

One session per week performed by research aide for four consecutive weeks.

Placebo Sessions

Gwen Wyatt, PhD, RN

The aim of this study is to test a complementary therapy intervention (reflexology) that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III or IV) breast cancer within the context of conventional medical care. Quality of life will be assessed via intermediate indicators: 1) physical indicators (greater physical functioning, lower presence of symptoms) 2) emotional indicators (greater spirituality, lower anxiety, and lower depressive symptomology); and the outcome indicator of quality of life.

The goal of this study is to test a complementary therapy intervention that will assist in improving quality of life (QOL) for women undergoing chemotherapy for late stage (III and IV) breast cancer within the context of conventional medical care. This longitudinal randomized clinical trial (RCT) will test a three-group design in which participants will continue to receive conventional care. Two groups of the study will involve a single-blinded four-week protocol: Group A will receive reflexology (a specialized foot therapy) from a certified reflexologist; Group B will receive placebo sessions from a research aide. The control group (Group C) will receive conventional medical care alone. The specific aims are: 1) to determine if women who receive either Groups (A or B) of an experimental protocol (reflexology or placebo) report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone (Group C); 2) to determine if women who receive Group A of an experimental protocol (reflexology), report significantly better QOL outcomes (total and subscales) at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving Group B (placebo; 3) to determine if women who receive either Group A or B of an experimental protocol (reflexology or placebo), report significant differences on Intermediate Indicators (physical and emotional), at 7 weeks, 13 weeks, and longitudinally over time, relative to women receiving conventional care alone; and 4) to determine if the Intermediate Indicators mediate the group effect on the QOL outcomes (total and subscales) at 7 weeks. This has the potential of leading to an enhanced system of care through the integration of conventional and scientifically-based complementary therapies. It also focuses on advanced disease that is currently under investigation in terms of supportive care measures. Finally, this study utilizes an improved design over existing work. It is a RCT with adequate numbers to detect group differences, and could ultimately serve as a model for rigorous investigation of other complementary therapies.

Reflexology: An Intervention for Advanced Breast Cancer

National Cancer Institute (NCI)

Michigan State University

Professor

Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member

Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient

Reflexology

The purpose of this project is to test foot reflexology delivered by a friend or family member in the home for women with breast cancer. The primary aims of the proposed study in a sample of women with breast cancer receiving chemotherapy and/or hormonal therapy are to determine the effects of 4 family- or friend-delivered weekly reflexology sessions compared to an attention control group.

This project tests the benefits of a home-based intervention of foot reflexology for improving health-related quality of life (HRQOL) including symptom responses, functioning, and health perceptions in women treated with chemotherapy for advanced breast cancer. Reflexology applies a firm walking-motion during sessions and is based on the premise that the foot has reflexes mirroring organs of the body. Symptom burden is the strongest predictor of HRQOL for cancer patients. This project brings together expertise from nursing, reflexology, communication, statistics, and health economics. The primary specific aims, in a sample of women with advanced breast cancer receiving chemotherapy, are to determine the effects of a 4-week, home-based reflexology intervention delivered by a friend/family provider compared to attention control for improvement of:

1. HRQOL including symptoms, functioning, and health perception at study weeks 5 and 11.

   The investigators hypothesize that the reflexology group will have better HRQOL (symptoms, functioning, and health perception) than the attention control group at study weeks 5 and 11.
2. Multiple symptom responses and times-to-response as determined by weekly symptom assessments during the 4-week intervention time.

   The investigators hypothesize that the reflexology group will have a higher proportion of symptoms that respond to the intervention and shorter time-to-symptom-responses than the attention control group.
3. Symptom-related use of unscheduled health services during the 11-week study. The investigators hypothesize that fewer unscheduled services will be used for symptom management over the 11-week study period by women receiving reflexology compared to women in the attention control.

The exploratory aims are to: 1) Explore differences between trial arms in perceptions of social support due to the family- or friend-delivered reflexology sessions at study weeks 5 and 11; 2) Determine if effects of the reflexology intervention on HRQOL are mediated by social support; and 3) Use the newly developed NIH PROMIS standardized symptom and functioning instruments to assess the effects of the reflexology intervention and to compare the responsiveness of PROMIS instruments and existing instruments designed to measure similar constructs.

This project has immense potential to make an effective symptom management intervention accessible to patients in their homes via a friend or family home provider. The investigators will not only intervene to enhance HRQOL but also to evaluate social support and costs associated with unscheduled health services. Effective symptom management provides time and cost savings to clinicians, advances the current state-of-the-science, and promotes adherence to medical treatment that may ultimately enhance survival.

Home-Based Symptom Management Via Reflexology for Breast Cancer Patients

The M.D. Anderson Symptom Inventory (MDASI) evaluates severity of 13 symptoms experienced by cancer patients (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling) on the scale from 0=symptom not present to 10=as bad as you can imagine. Summed symptom severity score ranging from 0 to 130 was derived. MDASI also assesses how much symptoms interfered with 6 aspects of daily life: general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life on the scale from 0=did not interfere to 10=interfered completely. Summed interference score ranging from 0 to 60 was derived.

Higher symptom severity and interference scores represent worse outcome.

1. PROMIS-Physical functioning subscale contains four items. Score for each item ranging from 1 to 5, yielding a total score ranges from 4 to 20. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.
2. PROMIS-Satisfaction with participation in social roles subscale contains four items. Score for each item ranges from 0 to 4, yielding a total score ranges from 0 to 16. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.

Higher scores representing better outcomes in each subscale.

The QLI assesses perceived quality of life including health and functioning domain, psychological/spiritual domain, social and economic domain, and family domain. The QLI consists of two sections: one measures respondent's satisfaction with the various domain of life and the other measures the importance of those domains. The satisfaction scores are centered and weighed by the importance scores to obtain the QLI composite score that ranges from 0 to 30 with higher scores representing better outcomes.

Measured by Conventional Health Service and Productivity Costs to assess the number of unscheduled times the patient visits an emergency room, urgent care center, and hospitalization.

Adverse events were tracked from patient's report of the unexpected foot effect (UFE) which adapted from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) including discomfort, numbness or tingling, discoloration or bruising.

Reflexology: 4 weekly foot reflexology sessions delivered by friend/family member.

Friend/family member was trained in foot reflexology protocol by certified reflexologist.

Friend/family member provides 4 weekly sessions to patient.

Intervention

Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Gwen Wyatt

MDASI summed symptom severity

MDASI summed symptom interference

Week 5 Intervention Group

Week 5 Control Group

Week 11 Intervention Group

Week 11 Control Group

Patient outcome data collected at week 5 and week 11

The M.D. Anderson Symptom Inventory (MDASI)

PROMIS-Physical function subscale

PROMIS-Social role subscale

Participant outcome data collected at week 5 and week 11

Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0

Quality of Life Index (QLI)

Number of emergency room visits

Number of urgent care center visits

Number of Hospitalizations

Participant outcome data collected at week 11

Use of Unscheduled Health Service

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Fatigue

Quality of Life

500 mg PG2 / 500 ml normal saline IV infusion for 3 hours once daily for 4 doses in the 1st week, 3 doses in the 2nd week and 3 doses in the 3rd week of each chemo-cycle for three cycles. Total 10 doses will be given in each cycle even with skip days.

The objective of this study is to evaluate the efficacy and safety of PG2 as a complementary treatment to conventional chemotherapy among NSCLC patients. In reference to previous studies, "Clinical Benefit Response" and "Incidence of Grade III plus VI Neutropenia" will be used as the primary endpoints in this study. Clinical Benefit Response is a metric measurement including change in cancer or cancer treatment related "fatigue" which is related to chronic fatigue syndrome (CFS), change in karnofsky performance status and change in weight. The secondary endpoints include patient's global quality of life, and the blood c-reactive protein level which is related to weight change, tumor response, survival time, incidences of myelosuppression (including neutropenia, anemia and thrombocytopenia) and the related G-CSF and antibiotics consumption.

This is a multi-center, double-blind, randomized and placebo-controlled study to evaluate complementary effect of PG2 in patients with advanced non-small-cell lung cancer under conventional chemotherapy. Patients with Stage IIIb-IV non-small-cell lung cancer will be screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.

All enrolled patients will be randomized to PG2 or Placebo arm and will receive the cisplatin-based chemotherapy treatment (Cisplatin 75mg/m2 and Docetaxel 60mg/m2 on Day1) during the first three 21-day chemo-cycles. Chemo regimen modification is allowable, as usual, in case of disease progression or unacceptable toxicity (see Section 6). After randomization, each patient will be administered with PG2 or placebo for 4 days in the 1st week, 3 days in the 2nd week and 3 days in the 3rd week of each chemo-cycle for 3 cycles (Dosing Schedule in Section 6). Total 10 doses will be given in each cycle.

Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue

PhytoHealth Corporation

Inflammation

Anti-Inflammatory Agents

All Drugs and Chemicals

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Hormones

Hands-on-Healing

Shamini Jain, Ph.D.

Paul J Mills, Ph.D.

This randomized controlled trial examines the efficacy of hands-on-healing for fatigue and immune function in breast cancer survivors. Participants may be randomized to one of three groups: hands-on-healing, touch alone, or a control group.

Please see our website at http://healing.ucsd.edu for detailed information on the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reflexology: An Intervention for Advanced Breast Cancer	NCT01577420	Breast Cancer	Reflexology Ses... Placebo Session...	21 Years -	Michigan State University
Home-Based Symptom Management Via Reflexology for Breast Cancer Patients	NCT01582971	Breast Cancer	Reflexology	21 Years -	Michigan State University
Complementary Treatment of PG2 to Improve Clinical Benefit Response and Quality of Life in Fatigue	NCT00518869	Quality of Life Fatigue Complementary	PG2	17 Years - 75 Years	PhytoHealth Corporation
Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors	NCT00440089	Breast Cancer	Hands-on-Healin...	18 Years - 70 Years	University of California, San Diego
Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors	NCT00440089	Breast Cancer	Hands-on-Healin...	18 Years - 70 Years	University of California, San Diego

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