Neoplasms

Blood and Lymph Conditions

All Conditions

Leukemia

Neoplasms by Histologic Type

Hematologic Diseases

Children with leukemia and their families/caregivers.

Questionnaires administered to pediatric patients and their parent(s) or caregiver(s).

Questionnaire

Martha Askins, PhD

Overall Objective:

The overall objective of this cross-sectional psychosocial study is to examine illness-related factors, family context factors, and child resiliency as predictors or correlates of child adjustment to leukemia treatment.

Primary Objective 1:

1(a): To examine illness-related factors (i.e., child's health and physical functioning and severity of the child's illness) as predictors of child psychological adjustment to leukemia.

1(b): To examine relapse status as a grouping variable affecting child psychological adjustment to leukemia.

1(c): To examine stage of treatment as a grouping variable affecting child psychological adjustment to leukemia.

Primary Objective 2:

-To examine family context factors (i.e., family psychosocial risk and parental emotional distress) as correlates of child psychosocial adjustment to leukemia treatment.

Primary Objective 3:

-To examine child resiliency as a predictor of child psychological adjustment to leukemia treatment.

Secondary Objectives:

* One secondary objective of the study is to examine parental distress as a moderator affecting parental report of child adjustment to leukemia as compared to the child's self-report of adjustment.
* Another secondary objective of the study is to develop a model by which the relative contribution of each predictor variable (as determined by analyses of primary objectives) as well as their interrelatedness can be understood in relation to child psychosocial adjustment.
* A third secondary objective of the study is to examine demographic variables as covariates in the main analyses. These variables include: age, grade, site, gender, ethnicity, type of leukemia, staging, time spent in treatment, age at diagnosis, and whether the child is undergoing standard or experimental treatment.

Parental Consent/Child Assent for Child Participants:

If you choose to take part in this study, you will be asked to complete a total of 2 or 3 questionnaires (depending on your age). Each questionnaire will be completed only once.

If you are between 6-7 years old, you will be given 2 questionnaires asking you about your physical health and illness, and your personal strengths. These questionnaires will take you about 30-45 minutes to finish. If you are between 8-18 years old, you will be given 3 questionnaires that will ask you about your physical health and illness, your personal strengths, and your emotional adjustment to the disease. These 3 questionnaires will take you about 30-45 minutes in total to finish. A research assistant will help you with the questionnaires, if you need help.

If you are given the questionnaires while you are at the hospital and you cannot complete them before you leave, you will be given a stamped envelope to mail the forms back to the study staff.

After your questionnaires are finished, a member of the research team might look at your medical chart if they need more information about your treatment or the status of the disease.

Parent Participants:

If you choose to take part in this study, you will be asked to complete a total of 5 questionnaires. These questionnaires ask information about your child's emotional adjustment to the disease, your child's physical health and illness, your child's personal strengths, your emotional distress, and the overall functioning of your family. Each questionnaire will be completed only once. It will take about 45-60 minutes to complete all 5 questionnaires.

Medical Staff Participants:

If you choose to take part in this study, you will be asked to complete a questionnaire that asks for information about the patient's illness. It will take about 3-5 minutes to complete this one-time survey.

All Groups:

This is an investigational study. About 220 people (100 children, 100 parents, and 20 medical staff) will take part in this multicenter study. About 130 will be enrolled at M. D. Anderson (60 children, 60 parents, and 10 medical staff members).

Children's Resiliency, Adjustment, and Coping

Children's Resiliency, Adjustment, and Coping: Cancer-Related, Family Context, and Within-Child Factors

M.D. Anderson Cancer Center

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month.

Individuals with stoma in the control group received the training of the company representative that sells stoma materials routinely in the hospital.

Educational booklets are given according to the type of stoma. The individual with the stoma was told that the researcher was always reachable by phone and could communicate if he had any problems. The individuals with stoma in the experimental group received the training of the company representative that sells stoma materials, which is routinely given in the hospital. After discharge, training was given by the researcher via video conference in a total of four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. A post-test was conducted at the end of the 4th training interview, which was administered via video conferencing.

At home education via video conferencing

Deniz HARPUTLU, PhD, RN

The aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance with stoma of individuals with stoma. In addition to the main purpose, it is aimed to determine whether stoma care education given via video conference at home has an effect on individuals with stoma to perform their own stoma care.

After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. Individuals with stoma in the control group received the training routinely given in the hospital. Self-efficacy and compliance with stoma were measured at baseline and at 2 months. The ability to care for one's own stoma was evaluated at the end of the study.

This study is a parallel group randomized controlled study.

The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma

The Effect of Education Via Video Conferencing at Home on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma

The Stoma Self-Efficacy Scale was developed to measure self-efficacy in individuals with stoma. The scale was developed by Bekkers et al. (1996). It is a 22-item scale with two sub-dimensions. Items in this scale are in 5-point Likert type. The first sub-dimension is the "Stoma Care Self-Efficacy" sub-dimension, which consists of the first 13 items. The second sub-dimension is the "Social Self-Efficacy" sub-dimension consisting of the remaining nine items. The minimum score that can be taken from the scale is 22, the maximum score is 110, and an increase in the score from the scale indicates high levels of self-efficacy. There is no reverse scored item in the scale.

It was created by Maekawa (2000) and later this scale was arranged by Simmons et al. (2009) in the form of Ostomy Adjustment Scale-23, consisting of 23 items and 4 sub-dimensions. OAS-23, a self-assessment scale, is a scale used to evaluate the level of adjustment in individuals with stoma. 4 sub-dimensions in this scale: accepting (includes items 1, 3, 4, 6, 9, 14, 15, 19, 23.), anxiety/worry (12, 13, 17, 20, 21 items) .), social cohesion (includes items 5, 7, 8, 11), and anger (includes items 2 and 10). At the same time, there are 3 items (16, 18 and 22) that are not included in any sub-dimensions. Each item of the scale is evaluated in a 5-point Likert type.

After the individuals with stoma in the experimental group were trained by the researcher throughout the study, it was evaluated that they could or could not perform their own stoma care under the supervision of the researcher. However, the status of individuals in the control group for maintaining stoma care is based on their own statements.

Ankara University

Student of master's degree

Symptoms and General Pathology

Recurrence

Thoracic Neoplasms

The intervention, "Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer," is a 10-week, manualized, group yoga program. Sessions are 60 minutes in duration, once a week, across the course of 10 weeks. The 10-week program is comprised of five modules, each of which will take two sessions to complete: (1) Getting Started, (2) Cultivating a Mindful Attitude, (3) Self-Care and Compassion, (4) Finding Peace and Acceptance, and (5) The Power of the Present Moment.

'Stilling the waters,' the prominent theme of this program, is drawn from the core principle in yogic philosophy. It uses breath techniques and physical postures to cultivate inner peace and an ability to live in the present moment. The emphasis on stilling the fluctuations of uncertainty is a direct allusion to the intrusive and inherently unknown future, which characterizes the core experience of Fear of Cancer Recurrence (FCR). This is especially true among gynecologic, gastrointestinal (GI), or thoracic cancer patients for whom the likelihood of recurrence is quite high. An additional motif throughout the program is the lotus flower. The symbolic importance of the lotus in yogic culture is due to its requiring thick muddy waters for ideal growth. The metaphor of cancer as the muddy waters will be used to cultivate benefit-finding and acceptance regarding the mental and physical challenges participants endured during their initial diagnosis and treatment.

Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer

Deidre B. Pereira, PhD

This study will test the feasibility and acceptability of a yoga program for women with gynecologic, gastrointestinal (GI), or thoracic malignancies. This study will pilot an integrative yoga intervention that combines Western psychotherapeutic approaches with classic yogic philosophy to reduce emotional distress among women undergoing treatment for gynecologic, gastrointestinal (GI), or thoracic cancer and provide a comprehensive approach to stress management across the cancer care continuum.

Gynecologic cancers are malignancies of the female reproductive tract that affect over 70,000 women per year. Treatments for gynecologic cancer often result in numerous physical and emotional side effects that affect long-term adjustment, such as anxiety, depression, low self-esteem, sexual dysfunction, difficulties with fertility, and surgically-induced menopause. Even when initial treatments are successful, gynecologic cancers have a high recurrence rate that can reach nearly 80% among those with ovarian cancer. Fear of Cancer Recurrence (FCR) is described as one of the largest unmet psychological needs among gynecologic cancer patients and is associated with psychological distress, increased health care utilization, and functional impairment. Few studies have examined interventions designed to manage symptoms of FCR, which leaves a significant gap in the literature regarding treatment of this prominent psychosocial problem. Cancer patients report growing use of integrative medicine therapies (e.g., yoga, acupuncture, massage) to manage unmet physical and emotional needs related to their disease and treatment. The current study will take advantage of this trend in supportive oncology to investigate the feasibility and acceptability of a novel intervention program created specially to address FCR among women with gynecologic cancer. Patients will be recruited from the UF Health/Shands Hospital Gynecology Oncology Clinic and Medical Oncology clinic and invited to participate in a 10-week, manualized, small group yoga course. Psychoeducation modules, meditation training, and gentle yoga poses will be integrated into a comprehensive program focused on managing the psychosocial concerns of newly diagnosed gynecologic cancer patients. Findings from this research will contribute to the existing literature on FCR and knowledge regarding the use of integrative medicine techniques for addressing unmet psychological needs among gynecologic cancer patients. If the intervention is deemed feasible and acceptable, future research may explore ways in which this manualized yoga program compares to other psychosocial treatments for managing FCR and other forms of emotional distress in women with cancer.

Yoga for Psychological Distress in Gynecologic, Gastrointestinal, or Thoracic Cancer

Feasibility, Acceptability, and Efficacy of a Yoga Intervention for Distress in Women With Gynecologic, Gastrointestinal, or Thoracic Cancer

Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility.

Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility

The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable.

This measure will access participants' Fear of Cancer Recurrence (FCR), which includes cognitive, behavioral, and emotional experiences related to worries that their cancer will return.

The Distress Thermometer will be used to assess cancer-related distress. This measure is designed to assess self-efficacy regarding distress and symptom management while facing a cancer diagnosis. Domains assessed include maintenance of activity and independence, seeking and understanding medical information, stress management, coping with treatment side effects, maintaining a positive attitude, engaging in emotion regulation, and seeking support.

Anxiety will be assessed with the State Trait Anxiety Inventory (STAI) Assesses state /trait anxiety symptoms on 4 pt. likert scale. Medium: May indicate anxiety disorder

Depressive symptoms will be assessed with the Beck Depression Inventory - Second Edition (BDI-2) - high score Suicidal Behavior

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Children's Resiliency, Adjustment, and Coping	NCT00489632	Leukemia	Questionnaire	6 Years - 18 Years	M.D. Anderson Cancer Center
The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma	NCT05531331	Stoma Ileostomy Stoma Colostomy Self Efficacy Adjustment Colorectal Canc... Colorectal Diso...	At home educati...	18 Years -	Ankara University
Children's Resiliency, Adjustment, and Coping	NCT00489632	Leukemia	Questionnaire	6 Years - 18 Years	M.D. Anderson Cancer Center
Yoga for Psychological Distress in Gynecologic, Gastrointestinal, or Thoracic Cancer	NCT03385577	Gynecologic Can... Adjustment Gastrointestina... Thoracic Cancer	Stilling the Wa...	18 Years - 90 Years	University of Florida

Spots Global Cancer Trial Database for adjustment

Every month we try and update this database with for adjustment cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for adjustment

Every month we try and update this database with for adjustment cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for adjustment cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.