Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Cognitive Behavioral Training 5 weekly 1.5-hour sessions of group-based cognitive behavioral training

Relaxation Training 5 weekly 1.5-hour sessions of group-based relaxation training

Health Education Control 5 weekly 1.5 sessions of group-based health education training

Cognitive Behavioral Training \[CBT\] (stress awareness, cognitive restructuring, coping skills training, interpersonal skills training)

Cognitive Behavioral Training

Relaxation Training \[RT\] (muscle relaxation, deep breathing, guided imagery, meditation)

Relaxation Training

Health Education control condition (information about breast cancer diagnosis and treatment, side-effect management, recurrence, physical activity and nutrition, and life after breast cancer)

Health Education Control

Michael H Antoni, Ph.D.

To test the effects of 2 different 5-wk stress management interventions (cognitive behavioral training or relaxation training) vs. a time-matched 5-wk health education condition on psychosocial adaptation and physiological adaptation in women being treated for breast cancer. Participants assigned to either of the stress management conditions will show improved psychosocial adaptation and physiological adaptation compared to those assigned to the health education condition.

This is a randomized controlled trial comparing the effects of 5-wk group-based stress management interventions (cognitive behavioral therapy \[CBT\] or relaxation training \[RT\]) vs a time-matched 5-wk group-based health education (HE) condition on psychosocial adaptation (negative and positive mood, social disruption) and physiological adaptation (cortisol and immune function) in women with non-metastatic breast cancer who are undergoing primary treatment. Participants are recruited in the weeks after surgery and before the start of adjuvant chemotherapy or radiation, are assessed for baseline psychosocial and physiological adaptation indicators, and are then randomly allocated to either CBT, RT or HE. They are re-assessed for psychosocial and physiological adaptation at 6 and 12 month follow-up. Primary hypothesis is that women assigned to CBT or RT will show greater reductions in negative affect and social disruption, and greater increases in positive affect over time compared to women assigned to HE. Secondary hypothesis is that women assigned to CBT or RT will show greater decreases in cortisol and greater increases in immune functioning over time compared to those assigned to HE.

Five Sessions Intervention to Facilitate Adaptation to Breast Cancer

Change from baseline to 12-month follow-up in the Affect Balance Scale- Negative Affect subscale. The Affect Balance Scale includes 40 adjectives assessing negative and positive mood. The Negative Affect subscale (i.e., depression, hostility, guilt, anxiety) will be used. Each emotional state is rated on a Likert Scale (0=never to 5= always) based on the past week and items are averaged, with higher scores indicating more negative affect. Possible scores range from 0-5.

Change from baseline to 12-month follow-up in the Affect Balance Scale- Positive Affect subscale. The Affect Balance Scale includes 40 adjectives assessing negative and positive mood. The Positive Affect subscale (i.e., affection, contentment, vigor, joy) will be used. Each emotional state is rated on a Likert Scale (0=never to 5= always) based on the past week and items are averaged, with higher scores indicating more positive affect. Possible scores range from 0-5.

Change from baseline to 12-month follow-up in the Sickness Impact Profile- Social Interaction subscale, a 16-item subscale measuring the level of disruption in social activities. Respondents are asked statements regarding social disengagement as they specifically apply to their breast cancer (e.g., "I am doing fewer social activities with groups of people") over the past few weeks, and are asked to respond either No (0) or Yes (1), this applies to me. Scores are summed, with higher scores indicating greater social disruption. Possible scores range from 0-16.

Change from baseline to 12 month follow-up in physiological adaptation (decreased serum cortisol, and increased Th1 cytokine production and lower Th2 cytokine production following anti-CD3 stimulation of peripheral blood mononuclear cells (PBMCs)

National Cancer Institute (NCI)

University of Miami

Professor

Hematinics

All Drugs and Chemicals

Gastrointestinal Agents

Liver Extracts

Pancrelipase

Pancreatin

Each participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery.

Each participant of the experimental group 2 receives 3 acupuncture treatments with a semi-standardized acupoint scheme: once a week over 2 weeks and the day before surgery.

Each patient of the experimental group 3 receives 3 acupuncture treatments with a semi-standardized acupoint scheme and 2 one-hour sessions of guided relaxation training prior to surgery.

Patients receive usual senological treatment

The relaxation sessions comprise an introduction in 3 relaxation techniques conducted by a mind-body therapist: "Body Scan", mindfulness meditation and imagination. Patients also receive a CD with different relaxation exercises and the instruction to exercise daily at home for at least 15 minutes.

relaxation training

The acupuncture treatment comprises needling of 6 standardized acupoints: Pericardium 6, Stomach 36, Large intestine 4, Spleen/Pancreas 10, Dumai 20, Liver 3, Shenmen. Additional points can be chosen individual.

acupuncture

Gustav J. Dobos, Prof

Breast cancer surgery is associated with presurgical psychological distress and clinically significant side effects including postsurgical pain, nausea and fatigue. A few studies have examined how to intervene to assist women undergoing breast cancer surgery. For example presurgical hypnosis has been proven to decrease side effects and even intraoperative anesthesia use. Besides the more psychologically based interventions there are a few studies suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery patients.This study aims to investigate whether a presurgical relaxation training, acupuncture treatment or a combination of both therapies is able to reduce presurgical psychological distress an postsurgical side effects in breast cancer patients in comparison to usual care.

Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients

Entspannung Und Akupunktur Zur Reduktion Perioperativer Symptome Bei Brustkrebspatientinnen- Eine Randomisiert-kontrollierte Interventionsstudie im Kontext Einer Integrativ Onkologischen Versorgung (EARpeS)

Measured by 100mm visual analog scale 1 day pre surgery

Measured by 100mm visual analog scale 1 day post surgery

Measured by 100mm visual analog scale 1 week post surgery

intraoperative analgesia use is taken from operative logs

intraoperative anesthesia use is taken from operative logs

postoperative analgesia use is taken from medical records

natural killer cell activity is measured at begin of surgery

natural killer cell activity is measured at end of surgery

Number of patients with adverse events are measured one week post surgery

Measured by Profile of Mood States (POMS) 1 day pre surgery

Measured by Profile of Mood States (POMS) 1 day post surgery

Measured by Profile of Mood States (POMS) 1 week post surgery

Universität Duisburg-Essen

Research fellow

Symptoms and General Pathology

Recurrence

Disease Attributes

ConquerFear-Group is a psychological intervention developed specifically for fear of cancer recurrence

The Relaxation Training serves as a placebo comparator and is not developed specifically to target fear of cancer recurrence.

The intervention consist of one 1½-hour individual session in which a psychologist will conduct an oral psychological assessment, and five 2-hour group sessions. The key goals of the intervention are to: a) teach strategies for controlling worry and excessive threat monitoring; b) modify underlying unhelpful beliefs about worry; c) develop appropriate monitoring and screening behaviors; d) educate about follow-up care and empirically-supported behavioral change (e.g., weight loss, exercise, etc.) to improve overall survival; e) address existential changes brought about by a cancer diagnosis; f) promote goal-setting. Each session is accompanied by home-based practice of skills learned in session and home reading to consolidate skill acquisition. Four trained psychologists (MSc) will perform the therapy. The intervention will be delivered on Zoom, a secure online platform.

ConquerFear-Group

The control group will receive one 1½-hour individual session and participate in five 2-hour group sessions. Patients will receive guided progressive muscle relaxation training. The intervention will be delivered on Zoom, a secure online platform.

Robert Zachariae, DMSc

The primary aim of this randomized controlled trial is to evaluate the effect of ConquerFear-Group (CF-G), compared with a control condition (CC), on Fear of Cancer Recurrence (FCR). Secondary aims are to explore the effect of CF-G on emotion regulation and additional psychological outcomes, and to explore mediating effects of emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion. In addition, treatment expectancy, participation in other treatments after completion of the intervention of the study and demographic and clinical variables will be explored as moderators.

A randomized controlled trial testing the efficacy of ConquerFear-Group (CF-G) on breast cancer survivors with clinical levels of Fear of Cancer Recurrence (FCR), compared with a control condition (CC), will be conducted.

The aims are to:

1. Evaluate the efficacy of CF-G on FCR,
2. Explore the effects on the secondary outcomes of emotion regulation, general distress, health-related QoL, survivors' unmet needs, mindfulness, metacognitions, intervention satisfaction, negative effects of intervention, and sleep.
3. Explore emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion will be explored as possible mediators.
4. Explore treatment expectancy, participation in other treatments after completion of the CF-G or the CC and demographic and clinical variables as possible moderators.

Primary hypothesis:

CF-G will yield larger reductions in FCR than CC at post treatment, and the effect will be maintained through the follow-up period.

Secondary hypotheses:

CF-G will demonstrate a larger improvement in measures of emotion regulation than CC following the intervention period.

Changes in emotion regulation during treatment will mediate the effect of CF-G on FCR.

Changes in metacognitions during treatment will mediate the effect of CF-G on FCR.

CF-G will yield larger reductions in general distress, health-related QoL, survivors' unmet needs than CC, and CF-G will yield larger improvements in metacognitions, mindfulness, and sleep than CC following the intervention period.

Participants are randomized in blocks of 16. Participants in each block will be randomly assigned in a 1:1 ratio to either CF-G or CC, resulting 2 x 8 groups of approx. 8 participants (min 5 and max 10 participants in each group). A computer-generated randomization list will be created by a person not directly involved in the intervention. Allocation to condition will take place after completion of the baseline questionnaire package

The investigator and assessor is masked in terms of not knowing to which condition the participants will be randomized until after completion of the baseline assessment. The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.

ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence

A Randomized Controlled Trial of ConquerFear: A Group-Based Psychological Intervention for Fear of Cancer Recurrence in Cancer Survivors

All data underlying publication will be shared in accordance with current data sharing regulations at host institutions.

Background information about the participants will be assessed with a questionnaire regarding demongraphic information as possible moderators

Clinical data will be explored as possible moderators

Treatment expectancy will be measured with the Credibility/Expectancy questionnaire as a possible moderator

Two questions regarding participation in other psychological, medical or complementary and alternative treatments for FCR after completion of the interventions of the present study will be assessed as a possible moderator

Changes in emotion regulation will be measured with the Brooding - Rumination and Reflection Scale

Changes in emotion regulation will be measured with the Penn State Worry Questionnaire

Changes in emotion regulation will be measured with the Experience Questionnaire

Changes in metacognitions will be measured with the Metacognitions Questionnaire-30

Changes in working alliance will be measured with the Working Alliance Inventory Revised Short Form

Changes in patient adherence will be assessed with a diary of home exercise completion

Changes in group cohesion will be assessed with the Therapeutic Factors Inventory Cohesiveness Scale

Single question to asses level of physical relaxation before and after each session

Single question to asses level of mental calmness before and after each session

Changes in fear of cancer recurrence will be measured with the 42-item Fear of Cancer Recurrence Inventory at baseline, 1 week post intervention, 3- and 6-months follow-up, and session-by-session with the 9-item Fear of Cancer Recurrence Inventory-Short Form

Changes in emotion regulation will be assessed with the Difficulties in Emotion Regulation Questionnaire

Changes in general distress will be measured with the Impact of Event Scale-Revised Questionnaire

Changes in general distress will be measured with the Depression, Anxiety, Stress Scale-21 Questionnaire

Changes in health-related quality-of-life will be measured with the European Organization for Research and Treatment of Cancer QLQ-C30 Questionnaire

Changes in health-related quality-of-life will be measured with EuroQol-5 Domain Questionnaire

Changes in survivors' unmet needs will be measured with the Survivors' Unmet Need Survey - 8 item Information Sub-Scale Questionnaire

Changes in fear of cancer recurrence will be measured with the Concerns About Recurrence Questionnaire

Changes in mindfulness will be measured with the Five Facet Mindfulness Questionnaire

Changes in sleep will be measured with the Insomnia Severity Index

Negative effects of the intervention will be assessed with one question about negative effects of the intervention experienced by the participants (narrative response)

Negative effects of the intervention will be measured with the Negative effects Questionnaire - hopelessness and failure subscales

Intervention satisfaction will be measured with three questions regarding satisfaction with the treatment

University of Aarhus

Aarhus University Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Quality of Life

All relaxation sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving relaxation will learn exercises to release tension through muscle relaxation, breathing, and imagery

All Healing Touch sessions will be given individually, and will be provided by trained nurses or research assistants. Patients receiving Healing Touch will receive a series of standardized therapeutic techniques designed to promote optimal flow of energy throughout the body.

The no intervention group will receive no special intervention other than standard medical care, which includes the regular medical care given by the patient's physician and health care professionals.

Relaxation training

Therapeutic touch

Questionnaire administration

Subjects in all groups will give 4 blood samples during the study

Ancillary studies

Susan Lutgendorf, PhD

The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.

Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression. This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.

Patients are randomized to relaxation, healing touch, or standard care arms of the study

Quality of Life Interventions During Cervical Cancer Treatment

Compare change in natural killer cell cytotoxicity of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.

Fresh peripheral blood mononuclear cells tested for cytolytic activity against the NK-sensitive K562 cells and the NK-resistant LAK-sensitive ZKBL cells in a standard 4-h 51Chromium- release assay.

Compare number of reported side effects of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care as measured by the Common Toxicity Criteria Manual Version 2.0

Compare number of days in treatment delay due to chemoradiation-related toxicity for participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care

Compare changes in depression scores of participants receiving HT to participants receiving relaxation training or usual care during radiation and chemotherapy as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) in which higher scores indicate worse depression (range 0-60)

Compare changes in reported anxiety of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Profile of Mood States- Anxiety Subscale (POMS-SF) (range 0-28)

Compare change in white blood cell counts of participants receiving HT during radiation and chemotherapy vs. patients receiving relaxation training or usual care during this time

hemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.

Compare change in red blood cell counts of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.

Compare change in reported quality of life of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Functional assessment of Cancer therapies (FACT). Higher scores indicate better quality of life. Range= (0-136).

Compare reported fatigue of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Fatigue Severity Inventory (FSI). Mean fatigue intensity (range 0-10) with higher scores indicating more fatigue, and fatigue duration in days last week experiencing fatigue (0-7 days) with greater number of days indicating greater fatigue duration.

Compare metabolic profile of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care. Samples were assayed using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS). The metabolomic profiling analysis measures the quantity of specific compounds in the plasma vs. a platform of 844 known metabolites in a commercial platform powered by Metabolon, Inc. For any specific metabolite, higher levels indicates greater presence of the metabolite.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Five Sessions Intervention to Facilitate Adaptation to Breast Cancer	NCT02103387	Breast Cancer	Cognitive Behav... Relaxation Trai... Health Educatio...	21 Years - 75 Years	University of Miami
Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients	NCT02276404	Breast Neoplasm...	relaxation trai... acupuncture	18 Years - 75 Years	Universität Duisburg-Essen
Five Sessions Intervention to Facilitate Adaptation to Breast Cancer	NCT02103387	Breast Cancer	Cognitive Behav... Relaxation Trai... Health Educatio...	21 Years - 75 Years	University of Miami
ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence	NCT04137575	Fear of Cancer ... Breast Cancer F...	ConquerFear-Gro... Relaxation Trai...	18 Years -	Aarhus University Hospital
Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients	NCT02276404	Breast Neoplasm...	relaxation trai... acupuncture	18 Years - 75 Years	Universität Duisburg-Essen
Quality of Life Interventions During Cervical Cancer Treatment	NCT04905576	Cervical Cancer	Relaxation trai... Therapeutic tou... Questionnaire a... Ancillary studi...	18 Years - 100 Years	University of Iowa
Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients	NCT02276404	Breast Neoplasm...	relaxation trai... acupuncture	18 Years - 75 Years	Universität Duisburg-Essen

Spots Global Cancer Trial Database for relaxation training