Behaviors and Mental Disorders

All Conditions

Quality of Life

patients who specify their preference for either acupuncture or touch therapy

with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup

Acupuncture points will be selected on an individualized and symptom-directed basis, with the incorporation of points shown in clinical research to be effective for specific symptoms

Acupuncture

Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch

Touch Therapies

Noah Samuels, M.D.

Nathan Cherny, M.D.

The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Organizations such as the American Society for Clinical Oncology and the European Society for Medical Oncology have included CIM modalities in their treatment guidelines, and many of today's leading cancer centers include CIM in their supportive care service. The proposed study will prospectively examine the impact of a CIM treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment.

A total of 750 patients will undergo an integrative oncologist (IP) consultation followed by a series of 8 CIM treatments consisting of either acupuncture or touch-related therapies (reflexology, Shiatsu, Tuina, etc.) with the goal of relieving their symptoms. Patients will be allocated to one of the two study treatment arms: the "Patient-Preference Arm", for patients who specify their preference for either acupuncture or touch therapy; and the "Randomized Treatment Arm", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. Patients will be asked to complete the following study questionnaires before and after the treatment regimen: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); the Edmonton Symptom Assessment System (ESAS); and the Measure Yourself Concerns and Wellbeing (MYCAW) tool. The primary study outcome will be the change in EORTC Global Health-Status / Quality of Life scores, from pre- to post-treatment. Secondary study outcomes will include EORTC QLQ-C30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; ESAS severity scores for 10 quality-of life related items; and MYCAW severity scores for the 2 most significant symptoms, as well as post-treatment narratives. Other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).

Patient-preference, pragmatic methodology

Integrative Oncology for Patient Symptoms

Examining the Impact of an Integrative Oncology Program on Patient Symptoms and Quality of Life: a Prospective Pragmatic Registry Protocol Study

Change from baseline to the end of the 8-week integrative treatment program

Change from baseline and 8-week assessment to 16 week follow-up

Change in severity scores for 10 quality-of life related items

Change in severity scores for the 2 most significant symptoms, as well as post-treatment narratives

Any reported adverse events taking place during the study period which are considered to have possibly/probably resulted from the CIM intervention

Adherence to oncology treatment to be measured using the Relative Dose Intensity (RDI) calculation

Narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).

Shaare Zedek Medical Center

Director, Center for Integrative Complementary Medicine

Symptoms and General Pathology

Death

Caregivers read to patients from literature of the patient's choice for recommended 20 minutes at least 3 times per week for 4 weeks.

Caregivers apply the instruction of the Touch, Caring and Cancer DVD program for patients for recommended 20 minutes at least 3 times per week for 4 weeks.

Caregivers read to the patient from literature of the patient's choice for recommended 20 minutes at least 3 times per week for 4 weeks

Attention control (reading)

DVD- and manual-based instruction for caregivers and patients in the use of touch and massage techniques as supportive care in cancer, including: preparation for a session, safety precautions related to cancer and its treatments, communication about touch, centering to calm the mind; manual techniques for the head, neck, shoulders, back, feet and hands to promote relaxation; and acupressure for pain, nausea and anxiety.

Touch, Caring and Cancer DVD program

William Collinge, PhD, MPH

RATIONALE: A multimedia education program for family caregivers that teaches simple methods of touch and massage for the comfort of cancer patients at home may be effective in lowering stress, reducing symptoms, and improving quality of life for patients; and may improve caregiver satisfaction and self-efficacy.

PURPOSE: This randomized phase II trial is studying how well multimedia instruction of caregivers in use of touch and massage works for cancer patients and their care partners.

OBJECTIVES:

Primary

* Produce a multimedia program to deliver instructional content in massage for cancer patients and their lay care partners.
* Determine the effects of the multimedia program on care partner esteem and stress and on the frequency and duration of the care partner's provision of their assigned form of support to the patient.
* Determine the effects of the multimedia program on patient symptom levels, functional quality of life, perceived stress, and physiologic indices of stress.

Secondary

* Examine the impact of the multimedia program on care partner concerns about use of touch as a form of support, and on self-efficacy in massage.

OUTLINE:

* Multimedia program production and screening (year 1): Patient/care partner dyads representative of a broad spectrum of relationships participate in filming a multimedia program about massage, acupressure, light touch, and massage safety precautions. The multimedia program is titled, "Massage for People with Cancer: Simple Instruction for Family and Friends." The program comprises a menu-driven DVD which allows the viewer to select English or Spanish as well as individual chapters of content, and a manual keyed to the DVD content. A different set of diverse patient/care partner dyads screen and critique the multimedia program.
* Randomized controlled study of program's efficacy (year 2): Patient/care partner dyads who reside in the same home are recruited. Dyads within each race/ethnic group are stratified by patient total scores on the baseline FACT-G assessment. Dyads are then randomized to 1 of 2 arms.

  * Arm I (experimental intervention): Dyads attend an orientation meeting with other dyads of their language group in order to meet the Oncology Massage Therapist (OMT) and research assistant (RA) assigned to them during the study; watch the DVD together and discuss it afterward; receive instructions for weekly data collection; and receive explanation about the safety monitoring home visit and the bi-weekly phone monitoring. Instructions for data collection include instructions for the care partner to fill out a sample of the weekly Study Report card. Dyads are given the DVD and manual to take home, and those who do not have a DVD player are provided one. Dyads complete at least one massage over at least 20 minutes once a week for 20 weeks in which they provide the techniques demonstrated in the film. An OMT makes a home visit to each dyad during the first 2 weeks, and then as needed, to monitor for understanding of and adherence to the relevant safety precautions for the given patient. Dyads receive bi-weekly telephone monitoring from an RA in order to encourage compliance with the weekly activity and monitor for any adverse events or safety concerns that warrant another home visit by the dyad's OMT (e.g., changes in medical treatment that call for changes in precautions).
  * Arm II (control intervention): For 4 weeks, care partners spend at least 20 minutes a week alone with the patient, reading to the patient from literature of interest to the patient. The literature may be fiction, non-fiction, or poetry that does not contain news or stressful subject matter. Dyads receive telephone monitoring from their RA within the first week and then every 2 weeks thereafter to encourage compliance, monitor for any adverse events or concerns, and respond to questions about the project. At the end of the 4 weeks, dyads attend an orientation meeting with the Principal Investigator, OMTs, and RAs. At this meeting, dyads view the multimedia program and discuss precautions and any other issues that may affect their utilization of the instruction. Dyads are then given the multimedia program to take home, and a DVD player if they need one. A home visit by an OMT is scheduled to assure the dyad understands and implements relevant safety precautions. The dyads then participate in the use of the intervention for the remaining 16 weeks of the study.

All participants in the study complete quality of life, perceived stress, and other questionnaires at baseline and then at 4, 12, and 20 weeks. Demographic and patient medical information is also collected. Saliva samples are collected from patients at baseline and then at 4, 12, and 20 weeks to monitor cortisol and DHEA levels.

Multimedia Training for Family Caregivers in Use of Touch and Massage in Supportive Cancer Care

Couples and Cancer: Building Partner Efficacy in Caring

National Cancer Institute (NCI)

Collinge and Associates, Inc.

President

Survey

Sexual health, a vital aspect of the overall human health and a critical component of quality of life, can be negatively affected by cancer and cancer treatments. Although prevalence rates of sexual difficulties vary depending on several factors including primary diagnosis, treatment modality and methods of assessment, estimates rates are reported to range from 40% to 100%. Despite the abundant literature on sexuality and intimacy, communication about sexual health is often absent or inadequate between patients and health care providers. In this context, more research is needed to understand patients' priorities and needs for information about sexuality.

The purpose of this study is to assess the main difficulties faced by patients in their sexual life and to evaluate patient's satisfaction after having followed sessions of psychosexual therapy proposed at Rafaël Institute, France. The survey will be conducted using questionnaires developed specifically for this study. All questions will be coded through a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses to each question will be analyzed with higher mean scores (\>4) indicating main difficulties faced by patients in their sexual life. Patients will also express their positive or negative state of agreement regarding questions evaluating their satisfaction after following a program of psychosexual therapy. Approximately 200 patients will be invite to participated in this survey after provided oral consent.

Sexual health, a vital aspect of the overall human health can be negatively affected by cancer and cancer treatments. Sexual dysfunctions affect the quality of life of an individual since sexual health is a critical component of overall quality of life. The World Health Organization (WHO) defines sexual health as "a state of physical, emotional, mental and social well-being in relation to sexuality; and not merely the absence of disease, dysfunction or infirmity". Indeed, regular sexual activity reduces stress, regularizes sleep cycle, and regulates our mental wellbeing as a whole.

Although prevalence rates of sexual difficulties vary among cancer patients and depend on several factors including primary diagnosis, treatment modality and methods of assessment, estimates rates can range from 40% to 100%. For example, in a French national survey focusing on sexual health of patients with colorectal or breast cancer two years after diagnosis, 54% of patients (235 of 435) reported to have a decrease in sexual desire and 61% had a decrease in frequency of intercourse.

Despite these problems have been well documented in the literature and in practice guidelines, many cancer survivors have limited access to high quality information on sexual health. Indeed, communication about sexual health is often absent or inadequate between patients and the medical team. Among barriers reported by health care providers for avoiding discussing this topic are lack of time, insufficient training, absence of awareness about the subject and unavailable access to integrative medicine solutions where they could send their patients. Cultural values, religious beliefs and social norms may also have significant implications.

Recognizing patients' sexual problems can help health care providers to offer appropriate integrative non-pharmacological interventions to different group of patients. In this context, more research is needed to understand patients' priorities and needs for information about sexuality. The purpose of this study is to assess the main difficulties faced by patients in their sexual life and to evaluate patient's satisfaction after having followed sessions of psychosexual therapy proposed at Rafaël Institute, France.

Survey of Sexual Health in Cancer Patients

Sexual Health in Cancer Patients: a Survey and Pilot Study of Psychosexual Therapy as a Non-pharmacological Supportive Care

Institut Rafael

All Drugs and Chemicals

Immunomodulating Agents

intervention low-protein diet arm (10% protein content)

Control diet consisting of 20% protein, intervention diet consisting of 10% protein

Diet

Ashlee Lang, MPH

Kyle Pasquariello, MA

Roberto Pili, MD

The main idea of this study is that a low protein diet may alter the environment surrounding the tumor, enhancing the body's immune response leading to greater anticancer effects of treatment. This study intends to use a low-protein diet as a tool to enhance the immune response generated by immune check point inhibitor treatments.

This is a single center, randomized, open label study to assess the feasibility of a low-protein diet intervention in cancer patients who are receiving immunotherapies. Subjects will be randomized in a 1:1 ratio to either immunotherapy plus control diet arm (\~20% protein content) or immunotherapy plus intervention low-protein diet arm (10% protein content).

A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies

Change in blood urea nitrogen (BUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.

Change in urine urea nitrogen (UUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.

Includes isolation and characterization of antigen specific T cell clones

Includes evaluation of antigen specific T cell populations by spectratyping T cell receptor expression

Includes characterization of antigen response by cytokine and chemokine production

Compliance with diet measured by self-report of patient

State University of New York at Buffalo

Associate Dean for Cancer Research and Integrative Oncology

Using dietary interventions as an adjuvant tool may represent an effective step toward advancing the treatment options of cancer. Dietary modifications can impact the growth and proliferation of tumors via multiple mechanisms

Caloric restriction may alter the response to chemotherapy induced stress response and enhance its antitumor effect. This study intends to use an intermitted caloric restriction protocol with alternate days before the chemotherapy administration to enhance the cytotoxic effect generated by standard treatment of cancer.

This pilot trial will provide preliminary evidence that 1) intermittent caloric restriction and a plant-based diet is feasible in cancer patients; 2) intermittent caloric restriction and a plant-based diet can be safely combined with standard chemotherapy; and 3) intermittent caloric restriction and a plant-based diet may reduce the side effects but increase the antitumor effects of standard chemotherapy.

Patients with cancer where SOC is represented by chemotherapy will be eligible for the study. After informed consent, eligible patients will be scheduled to the chemotherapy. Each cycle will be every 14, 21 or 28 days depending on the regimen. The diet intervention will commence 1 week prior to the first infusion (i.e. on Day -5 for regimens every 21-28 days, on Day-3 for regimens every 14 days) and will continue until the end of cycle 4 or 6 depending on the regimen in the neoadjuvant or adjuvant setting. For metastatic disease the dietary intervention will last until cycle 6 and not beyond

A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy

A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Protein Diet in Cancer Patients Receiving Chemotherapy

compliance with diet measured by self-reports

objective response rate (partial + complete response)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Integrative Oncology for Patient Symptoms	NCT04940780	Oncologic Compl... Symptoms and Si...	Acupuncture Touch Therapies	18 Years -	Shaare Zedek Medical Center
Multimedia Training for Family Caregivers in Use of Touch and Massage in Supportive Cancer Care	NCT00632398	Cancer	Attention contr... Touch, Caring a...	21 Years - 120 Years	Collinge and Associates, Inc.
Integrative Oncology for Patient Symptoms	NCT04940780	Oncologic Compl... Symptoms and Si...	Acupuncture Touch Therapies	18 Years -	Shaare Zedek Medical Center
Survey of Sexual Health in Cancer Patients	NCT06428279	Integrative Onc...	Survey	18 Years -	Institut Rafael
A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies	NCT05356182	Medical Oncolog... Integrative Onc... Medical Nutriti...	Diet	18 Years -	State University of New York at Buffalo
Multimedia Training for Family Caregivers in Use of Touch and Massage in Supportive Cancer Care	NCT00632398	Cancer	Attention contr... Touch, Caring a...	21 Years - 120 Years	Collinge and Associates, Inc.
A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy	NCT05359848	Medical Oncolog... Integrative Onc... Medical Nutriti...	Diet	18 Years -	State University of New York at Buffalo

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