Behaviors and Mental Disorders

All Conditions

Stress, Psychological

Behavioral Symptoms

Quality of Life

Participants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period.

Participants in this group will receive standard education.

The CBT skills target reducing anxiety, (e.g., relaxation), changing negative appraisals (e.g., cognitive restructuring), coping skills training (e.g., enhancing adaptive skills), behavioral activation, interpersonal skills (e.g., communication skills) and building or enhancing social networks. The intervention will be administered online, and each module will last about 1-hour.

Cognitive Behavioral Therapy (CBT)-based skills

Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer.

Standard Education

Sara Fleszar-Pavlovic, PhD

Frank Penedo

Frank Penedo, PhD

The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.

QOL and GI Outcomes in Malignancies

Psychosocial Determinants of Health-Related Quality of Life (QOL) and Gastrointestinal (GI) Functional Outcomes During Treatment for Malignancies

Perceived Stress Scale (Scale of 1-40 with higher scores indicating higher stress)

UCLA Loneliness Scale (Scale of 20-80 with higher scores indicating higher loneliness)

Interpersonal Support Evaluation List (12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support).

FACT-G7 (Scale of 0-28 with higher scores indicating better quality of life)

FACT FHSI-18 (Scale of 0-72 with lower scores indicating better quality of life)

GSRS (Scale of 0-78 with higher scores indicating worse gastrointestinal symptoms)

University of Miami

Professor

Wonders \& Worries Psychosocial intervention is a 6 week group or individual sessions for children who have a parent with cancer focusing on psycho-educational information about cancer, treatment and its side effects, feelings expression, positive coping strategies, and family communication about the illness.

Wait list group will complete baseline, 6 week and 8 week follow up measures and then will be enrolled to receive W \& W intervention.

Session 1: Getting to Know Each Other The goal is to create a sense of safety within the group so that the children feel comfortable discussing difficult topics. Session 2: Cancer Education to provide developmentally appropriate education about the illness, treatment, and side effects. Session 3: Cancer Treatment Center Tour: This session consists of a treatment center tour and education about treatment plan involved in family's care in a safe environment. Session 4: Feelings: The focus of this session is expression and validation of all feelings the children may experience. Session 5: Stress and Coping: Goal is to emphasize the different ways individuals cope and differentiate positive vs. negative coping strategies. Session 6: Hopes for the Future/Closure: An emphasis is made on the idea that positive things may evolve from the most difficult circumstances.

Wonders & Worries Psychosocial Intervention

Farya Phillips, PhD

Parental cancer can cause substantial behavioral and emotional distress in both parent and child. Parents struggle with talking with their child about their cancer and supporting the child during treatment. Over 73% of patients with children desire information and services to support their children yet only 9% of these families report receiving this support. The purpose of this study is to evaluate the Wonders \& Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer.This study is a randomized controlled clinical trial (RCT) evaluating the Wonders \& Worries group and individual intervention for school age children (5 -14 years old) who have a parent with cancer. Families will be enrolled at the time of initial parent consultation, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), and the Family Communication Scale FACES IV at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.

The purpose of this study is to evaluate the Wonders \& Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer. The Wonders \& Worries program curriculum is a psychosocial intervention that was designed to address the communication and distress issues raised in prior descriptive research and to respond to the limitations of current research. The goals of the program are to improve children's behavioral-emotional adjustment to their parent's cancer, improve parenting behavior (parenting quality, skills and self-efficacy), and increase family communication about the illness. The aim of the current study is to evaluate the efficacy of the Wonders \& Worries program on child and parent outcomes within a randomized clinical trial.

Wonders \& Worries is an Austin based non-profit agency. Wonders \& Worries works with families in all stages of survivorship, who are affected by any serious or chronic physical illness.

The fully scripted intervention involves 6 group or individual sessions for the children, each of which is briefly summarized, in Table 1. Families will be enrolled at the time of initial parent consultation at Wonders \& Worries, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), the Family Communication Scale FACES IV, and the AMMI-EC3- About My Mommy's Illness at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.

The intervention will be provided by Wonders \& Worries certified child life specialists. Child life specialists are professionals trained to help children and their families understand and manage challenging life events and stressful health care experiences. By using play, recreation, education, self-expression and theories of child development, these specialists help promote the psychological well-being and optimum development of children and families faced with stressful situations. At Wonders \& Worries all services are provided by master's prepared certified child life specialists.

Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer

Revised Children's Manifest Anxiety Scale - child self report

child self report of worries related to parent's illness AMMI-EC3- About My Mommy's Illness

Wonders & Worries

University of Texas at Austin

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Aesthetic care

Fabrice LAKDJA, MD

The aim of this study is to evaluate the impact of a socio-aesthetic intervention on body image and quality of life in post-surgical patients with mastectomy or tumorectomy for breast cancer.Two groups of randomized subjects were constituted. Patients of the experimental group received 2 or 3 aesthetic care during the first post-surgical week, whereas those of the control group not. Body image, quality of life and diverse other personality variables were assessed at three different times: surgical operation day before, exit day before of hospitalization and three months afterwards. Our general hypothesis is that subjects who receive aesthetic care report levels significantly higher of corporal satisfaction and of quality of life at the end of the hospitalization and three months later than patients of the control group.

Socio-aesthetic Intervention on Body Image and Quality of Life in Women With Breast Cancer.

Impact of a Socio-aesthetic Intervention on Body Image and Quality of Life in Patients With Mastectomy or Tumorectomy for Breast Cancer.

Institut Bergonié

Depressive Disorder

Depression

Three months of web-based CaringGuidance psychoeducational program use, independently on home computer in addition to usual care.

Three months of care as usual from subjects' clinics and community as the subject chooses.

CaringGuidance After Breast Cancer Diagnosis, psychoeducational, Internet-accessible program

CaringGuidance After Breast Cancer Diagnosis

Robin M Lally, PhD

Approximately 30% of U.S. breast cancer survivors experience significant cancer-related distress ranging from adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. For rural cancer survivors, lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. However, these barriers may be overcome by a new Internet-based psychoeducational program designed for newly diagnosed women; CaringGuidance™- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding and provide supportive tools to prevent/manage distress and depressive-symptoms. This pilot study will determine preliminary efficacy of the CaringGuidance™ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer.

Of the 3.1 million U.S. breast cancer survivors, approximately 30% experience significant cancer-related distress ranging from sub-threshold to diagnosable adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. Rural cancer survivors report poorer mental health than urban survivors. Lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. These barriers may be overcome by a new Internet-based, psychoeducational program designed for newly diagnosed women; CaringGuidance™- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding, and provide supportive tools to prevent/manage distress and depressive-symptoms.

The aims of this pilot study are to determine preliminary efficacy of the CaringGuidance™ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer, and trial measures and methods, prior to a fully powered randomized controlled clinical trial.

Sixty rural women, will be randomized to 3 months of self-guided CaringGuidance™ program access with usual care or usual care alone. Both groups complete monthly standard psychosocial measures, daily activity/symptom logs and receive a monthly call. Program engagement/dose will be measured by the CaringGuidance™ internal data system. Descriptive and inferential statistics will characterize the sample and determine differences between groups at monthly intervals and overall. Variability of outcome variables will also be assessed to determine usefulness.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
QOL and GI Outcomes in Malignancies	NCT04815746	Psychological A... Psychological A... Stress, Emotion...	Cognitive Behav... Standard Educat...	18 Years -	University of Miami
Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer	NCT02758639	Cancer Psychological A...	Wonders & Worri...	5 Years - 14 Years	University of Texas at Austin
Socio-aesthetic Intervention on Body Image and Quality of Life in Women With Breast Cancer.	NCT00210145	Breast Cancer	Aesthetic care	30 Years - 75 Years	Institut Bergonié
Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer	NCT02758639	Cancer Psychological A...	Wonders & Worri...	5 Years - 14 Years	University of Texas at Austin
Socio-aesthetic Intervention on Body Image and Quality of Life in Women With Breast Cancer.	NCT00210145	Breast Cancer	Aesthetic care	30 Years - 75 Years	Institut Bergonié
QOL and GI Outcomes in Malignancies	NCT04815746	Psychological A... Psychological A... Stress, Emotion...	Cognitive Behav... Standard Educat...	18 Years -	University of Miami
Reducing Distress and Depressive-symptoms in Rural Women	NCT03465813	Breast Cancer Psychological A...	CaringGuidance ...	19 Years - 85 Years	University of Nebraska
QOL and GI Outcomes in Malignancies	NCT04815746	Psychological A... Psychological A... Stress, Emotion...	Cognitive Behav... Standard Educat...	18 Years -	University of Miami
QOL and GI Outcomes in Malignancies	NCT04815746	Psychological A... Psychological A... Stress, Emotion...	Cognitive Behav... Standard Educat...	18 Years -	University of Miami

Spots Global Cancer Trial Database for psychological adjustment