Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

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

All Drugs and Chemicals

Vaccines

Mimia C Logsdon, DNS, ARNP, FAAN

Preventing cervical cancer is a public health concern. Since 2006 a quadrivalent vaccine for young women nine to twenty six years of age has been available to protect against the human papillomavirus (HPV) and to prevent some types of cervical cancer (Gardasil). The vaccine is an important health promotion tool to address the widespread prevalence of HPV and cervical cancer, but not all eligible young women receive the vaccine. The vaccine is most effective when administered to young women before their sexual debut. When the vaccine is given to young women less than 18 years of age, parental permission is required. This permission is usually provided by the young woman's mother. Understanding predictors of a mother's decision for her minor daughter to receive the HPV vaccine will inform interventions that seek to increase the number of young women who receive the vaccine.

The study will focus on mothers and their adolescent daughters between 13-17 years of age. We hypothesize that the Expanded Theory of Planned Behavior will explain a mother's decision to choose the HPV vaccine for her daughter.

Research Questions include: 1)What TPB variables predict a mother's decision to choose HPV vaccine for her daughter? 2)What variables predict the strength of a daughter's influence on the mother's decision to choose HPV vaccine for her daughter? 3) What are the relationships between the mothers' and daughters' scores on the variables related to the decision to choose HPV vaccine? 4) How do the mothers and daughters who chose to receive the HPV vaccine differ descriptively from those mothers and daughters who do not choose to receive the HPV vaccine?

Preventing cervical cancer is a public health concern. Since 2006 a quadrivalent vaccine for young women nine to twenty six years of age has been available to protect against the human papillomavirus (HPV) and to prevent some types of cervical cancer (Gardasil). The vaccine is an important health promotion tool to address the widespread prevalence of HPV and cervical cancer, but not all eligible young women receive the vaccine. The vaccine is most effective when administered to young women before their sexual debut. When the vaccine is given to young women less than 18 years of age, parental permission is required. This permission is usually provided by the young woman's mother. Understanding predictors of a mother's decision for her minor daughter to receive the HPV vaccine will inform interventions that seek to increase the number of young women who receive the vaccine.

Health behavior theories, such as the Theory of Planned Behavior (TPB), indicate the factors and mechanisms that predict health promotion decisions and activities. TPB provides a direct statistical model through which variables related to health behaviors can be measured and evaluated, and will be used to guide the proposed study.

The study will focus on mothers and their adolescent daughters between 13-17 years of age. The normative changes and realignments in the parent child relationship that arrive with the onset of adolescence, coincide with greater adolescence behavioral autonomy, and influence over parental decisions related to the adolescent. Thus, we expanded the TPB to include the influence of the adolescent on the mother's decision for her daughter to receive the HPV vaccine.

Hypothesis: We hypothesize that the Expanded Theory of Planned Behavior will explain a mother's decision to choose the HPV vaccine for her daughter.

Research Questions:

RSQ1: What TPB variables predict a mother's decision to choose HPV vaccine for her daughter?

RSQ2: What variables predict the strength of a daughter's influence on the mother's decision to choose HPV vaccine for her daughter?

RSQ3: What are the relationships between the mothers' and daughters' scores on the variables related to the decision to choose HPV vaccine?

RSQ4: How do the mothers and daughters who chose to receive the HPV vaccine differ descriptively from those mothers and daughters who do not choose to receive the HPV vaccine?

Data will be analyzed using path analysis, multiple regression, and analysis of variance. The model demonstrates multiple potential influences on the mother's decision to choose the HPV vaccine for her daughter, and all influences are potential targets for family teaching interventions and tailored social marketing. Further study will be needed to determine how well the model applies to various family types and diverse cultures and nationalities.

Health Care Decisions for Female Adolescents: The Role of Mothers and Daughters in Decision Making

Merck Sharp & Dohme LLC

University of Louisville

Professor

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Breast Neoplasms

Weight Loss

Body Weight

Breast Diseases

Skin Diseases

Quality of Life

7 sets of print materials will be mailed every 6-7 weeks. A short survey about the information received and how useful it was will be completed.

Standardized Materials Group

Personalized notebooks and newsletters of diet and exercise information will be mailed. A short survey about the information received and how useful it was will be completed.

Independent Tailored Intervention

Daughters and Mothers, as a team, will each receive personalized notebooks and newsletters of diet and exercise information. A short survey about the information received and how useful it was will be completed.

Partner-Assisted Tailored Intervention

Wendy Demark-Wahnefried, PhD

Primary Aim:

-To explore the feasibility and acceptability of two distinctly different tailored, home-based diet and exercise interventions (one that relies on a partner-assisted, team-based approach that emphasizes the mother-daughter bond and one that is delivered to each independently) vs. standardized materials (attention control). This aim will be accomplished by assessing overall accrual, and by quantifying retention and adverse events in each study arm.

The study will be deemed feasible if it achieves the following criteria:

1. Accrual of 67 mother-daughter dyads into the intervention is accomplished within a 1-year period;
2. An attrition rate of less than 20% is achieved; and
3. The frequency of total adverse events is not significantly higher in either of the intervention arms (as compared to the attention control arm), and there is no more than one reported serious adverse event that is directly attributable to either of the interventions.

Detailed process data also will be collected on each intervention, i.e., use and perceived helpfulness of materials in promoting behavior change, frequency and quality of interaction between members of the mother-daughter dyad, feedback regarding intervention materials, etc.

Secondary Aim:

-To explore potential effects (and variation) noted among each of the three intervention arms from baseline to 6 and 12- month follow-up on the following endpoints: BMI, energy intake and nutrient density of the diet, exercise \[min/week and metabolic equivalents (METs)\], self-efficacy to adhere to an energy restricted, plant-based, low saturated fat diet and increased exercise, blood pressure, health-related quality of life (HRQOL), social support (in general and as specifically related to healthful dietary and exercise behavior), and characteristics of the mother-daughter bond (e.g., strength).

Secondary Aim:

-To explore potential mediators and moderators of healthful dietary and exercise behaviors, such as the strength of the mother-daughter bond, geographic proximity of mothers and daughters, self-efficacy for lifestyle change, etc.

DAUGHTER AND MOTHER - FULL INTERVENTION STUDY:

Women who are overweight have a greater chance of developing breast cancer as they get older, and also are at greater risk of developing more aggressive cancer. Researchers want to study 3 different home-based diet and exercise weight loss programs and find out the effect of the programs on body weight, quality of life, and other health-related factors.

If you and your mother agree to participate in this year-long research study, you will be asked to sign this consent form and send it into our study office in the envelope provided. As soon as the study staff receives these forms from both you and your mother, they will contact you to schedule your first study visit.

First Study Visit:

If you live within 60 miles of the clinic, you will be asked to come in for an in-person appointment that lasts about 1 hour. During this visit, the study staff will measure your height, weight, blood pressure, and your waist (using a tape measure).

You will also be asked to have cardiopulmonary exercise testing, also known as a "stress test." The purpose of this test is to check your fitness level. During this test, you will pedal a stationary (exercise) bicycle. You will be asked to pedal at the same speed, as the difficulty is increased every minute. It will feel like you are pedaling up a hill that gets steeper and steeper. The test is stopped when you cannot pedal at the desired speed or you become too tired to pedal.

To accurately measure your fitness level, the study staff will measure the air that comes in and out of your mouth during exercise. You will be asked to wear a mouthpiece (similar to a snorkel used in deep sea diving) which is connected to a tube that sends the air you breathe out into a machine where it is tested. The exercise test will last about 8-12 minutes. As a safety precaution, during the test the study staff will also monitor your heart rate using a 12-lead electrocardiogram (ECG--a test that measures the electrical activity of the heart). This means that the study staff will place electrodes (sticky pads) at certain locations on your body so that they can monitor how your heart responds to exercise.

If you do not live within 60 miles of the clinic, or if you do not or cannot report to these medical centers, the study staff will send a study nurse to your house (or another location easy for you to reach) to measure your height, weight, blood pressure, and your waist (using a tape measure).

If the blood pressure measurement shows that your blood pressure is elevated (greater than 179/109), the study chair will need your personal doctor to say it is okay for you to take part in the study.

Activity Monitor and Phone Interviews:

After your first study visit, you will be given an activity monitor and instructions to wear it on your waistband or belt (like a pedometer), during the time you are awake, for 7 days in a row. The activity monitor will record your daily activity. At the end of the 7 days, you will be asked to return the activity monitor using a pre-addressed, postage-paid return envelope that you will be given to you with the monitor.

You will also receive a food poster and survey guide after your first study visit. You will use these to participate in 2 unscheduled telephone interviews within the next month. Each interview will take about 30 minutes. At the beginning of the interview, the interviewer will ask if the time is convenient for you, or if you need to reschedule the call for another time when you are available. During these interviews, you will be asked questions about your health and your diet and exercise behaviors.

Study Groups:

After both you and your mother have completed your surveys and the information from your activity monitor has been received by the study staff, both you and your mother will be randomly assigned as a team (like drawing names from a hat) to 1 of 3 intervention groups. All 3 interventions will not start sooner than 6 months after your mother's cancer diagnosis, to allow time for her to recover from treatment.

Standardized Materials Group:

If you are assigned to this group, you will be asked to exercise and to improve your diet to the best of your ability. In order to do this, you will receive 7 sets of print materials about diet, exercise, and other health information. These materials will be mailed every 6-7 weeks throughout the 1-year intervention period. After each mailing, you will be asked to complete a short survey (16 questions) about the information you received and how useful it was for you. You will be asked to return the survey in a prepaid, addressed envelope that was sent with the materials.

Independent Tailored Intervention Group If you are assigned to this group, you will be asked to exercise and to improve your diet to the best of your ability. In order to do this, you will receive a personalized notebook of diet and exercise information, which will be mailed to you at the start of the intervention. About every 6-7 weeks throughout the 1-year intervention period, you also will receive 6 personalized newsletters that will also provide you with more information. After each mailing, you will be asked to complete a short survey (16-20 questions) about the information you received and how useful it was for you. You will be asked to return the survey in a prepaid, addressed envelope that was sent with the materials.

In addition, you also will be given the following equipment and supplies to help you exercise and eat better:

* A pedometer, which is a small device worn just like the activity monitor that counts the number of steps you take each day;
* An Apple Nike + iPod® Sport kit (including iPod) that will play music to exercise to and record the time and distance you exercise;
* Food portion and fat information guides to help you make good food choices; and
* Logbooks that you will use to record what foods you eat and your exercise behaviors while you are on study.

Partner-Assisted Tailored Intervention Group:

If you are assigned to this group, you and your mother, as a team, will be asked to exercise and to improve your diets to the best of your ability. In order to do this, you will each receive a personalized notebook of diet and exercise information, which will be mailed to you at the start of the intervention. About every 6-7 weeks throughout the 1-year intervention period, you also will receive 6 personalized newsletters, which will also provide you and your mother with more information. After each mailing, you will be asked to complete a short survey (16-20 questions) about the information you received and how useful it was for you. You will be asked to return the survey in a prepaid, addressed envelope that was sent with the materials.

In addition, you and your mother also will be given the following equipment and supplies to help you exercise and eat better:

* A pedometer, which is a small device worn just like the activity monitor that counts the number of steps you take each day;
* An Apple Nike + iPod® Sport kit (including iPod) that will play music to exercise to and record the time and distance you exercise;
* Food portion and fat information guides to help you make good food choices; and
* Logbooks that you will use to record what foods you eat and your exercise behaviors while you are on study.

These materials that you will receive will emphasize a "team approach" to weight loss, and will encourage you and your mother to support one another. If you are assigned to this group, you will be encouraged to talk with your mother regularly. The study will reimburse you for up to 20 minutes/day of telephone calls between you and your mother. You will be told how to submit these phone charges if you are assigned to this group.

Follow-up Interviews and Visits:

At both 6 months and 1-year after you start this study, you will have a telephone interview with a member of the study staff. Each interview will last about 30 minutes, and will involve the same information collected during the 2 interviews at the beginning of study participation.

You will also be asked to take part in 2 more in-person visits (one at 6 months and another after a year) that will be like the visits performed at the beginning of the study.

Up to 134 women (67 mother-daughter pairs) will take part in this multicenter study. Up to 34 mother-daughter pairs will be enrolled at M. D. Anderson, and the rest will be enrolled at the Duke Comprehensive Cancer Center.

DAMES: Daughters And MothErS Against Breast Cancer

National Cancer Institute (NCI)

Duke University

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Must have been in a partnership at the time child was diagnosed with cancer \&amp; must have been diagnosed at least 3 months prior to enrollment on this study \&amp; be currently receiving treatment

Must have been in a partnership at the time the child was diagnosed with cancer and the child has completed treatment at age 21 or younger (without evidence of disease) within the previous 3 years

Must have been in a partnership at the time the child was diagnosed with NF1 and the child must have been diagnosed with NF1 at least 3 months prior to enrollment on this study.

Lori Wiener, Ph.D.

Background:

- Serious illnesses like cancer or Neurofibromatosis Type 1 (NF1), can cause high levels of stress in a family. When a child is diagnosed with cancer or NF1, parents face numerous stressors, each of which can strain relationships. Many parents struggle to effectively cope with the changes in parenting roles that often accompany treatment of childhood cancer or NF1. How parents cope with this stress can influence whether the relationship is strengthened or weakened. Stress levels can also affect the care of the child who has cancer or NF1. Researchers want to better understand the critical time points and events during the child s treatment when the relationship becomes most stressed and/or strengthened.

Objectives:

- To study how stress affects the relationship between parents who have a child with cancer or Neurofibromatosis Type 1 (NF1).

Eligibility:

* Parents of a child (between 1 and 24 years of age) who has been diagnosed with cancer or NF1.
* Participants must have been in a partnership at the time the child was diagnosed with cancer or NF1. At least one of the parents must be a biological or legal parent of the child.

Design:

* Participants will fill out a questionnaire either online or by paper and pencil. It will take about 20 minutes to complete. The questions ask about the experience of dealing with a child s cancer OR NF1 diagnosis and how it affects participants relationship with their spouse/partner.
* Some participants will also have an in-depth interview. It will last about an hour. It will ask further questions about the cancer OR NF1 diagnosis and treatment and its effect on the relationship.
* Treatment will not be provided as part of this study.

Background:

* Parents face numerous stressors when their child is diagnosed with cancer or NF1, each of which can strain a marriage/partnership.
* Marital/partner relationship dynamics are often not assessed or addressed when providing health care for children with cancer or NF1. Many parents struggle to effectively cope with the changes in parenting roles that frequently accompany treatment of childhood cancer or NF1.
* How parents cope with these stressors can strengthen or weaken the relationship, and can impact the entire family, including the care to the child undergoing cancer or NF1 treatments.
* Limited studies have examined relationship stress or satisfaction during a child s illness trajectory for cancer or NF1 or the critical time points and events during the child s illness trajectory when the relationship becomes most stressed and/or strengthened.

Objectives:

* To explore whether the stress associated with having a child with cancer or NF1 is perceived to impact the communication between partners.
* To explore whether positive dyadic coping (joint decision making, joint problem solving, sharing responsibilities) is perceived to have strengthened the marital relationship/partnership following the child s diagnosis with cancer or NF1.
* To describe the time points and events during the child s illness trajectory when the parents relationship becomes most stressed and/or strengthened.
* To compare the perceptions of various subgroups in the sample, (e.g. parents who score either high or low on a marital stress scale, mothers versus fathers) statistically or qualitatively as the distribution of the characteristics of the sample allow.

Eligibility:

* Participants must have been in a partnership at the time the child was diagnosed with cancer or NF1. At least one of the participating parents must be a biological or legal parent of the child. If a divorce/separation occurred with a previous partner during/after the child s diagnosis, the other partner will be invited to participate.
* The participant s child must be between 1-24 years of age.
* There are 3 groups of participants being recruited: 1) those who have a child who has been diagnosed with cancer at least 3 months prior to enrolling on this study and are currently undergoing cancer treatment, 2) those who have completed treatment at age 21 or younger (without evidence of disease) within the previous 3 years, and 3) those who have a child who has been diagnosed with NF1 at least 3 months prior to enrolling on this study.
* Participants must be fluent in the English language
* The participant s child must have been diagnosed with cancer or NF1 at least 3 months prior to enrollment on this study.
* Participants must verbalize willingness to discuss the impact of their child s cancer or NF1 diagnosis on their relationship.

Design:

* Cross-sectional, multi-center, exploratory study utilizing a convenience sample to explore the parents perception of how the child s cancer or NF1 diagnosis, treatment, decision making and other aspects of care are addressed and impact the martial relationship/partnership.
* Subjects will complete a self-administered measure that addresses potential stresses experienced in the partnership since the child s diagnosis and how each are either resolved or create a divide in the relationship.
* Subjects who experience a high or low degree of relationship stress on a standardized marital stress form (a score greater than one standard deviation from the norm) will be invited to participate in a qualitative interview, that further explores which components of parenting a child with cancer is most challenging on the relationship.
* Up to 360 participants will be enrolled onto this study (up to 180 couples). Subjects may be offered a gift card ($20 Target gift card at NIH) upon completion of the questionnaire for their time and inconvenience, where available. Due to limitations with funding, participants enrolled after July 2016 will not receive a gift card.

Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)

Understanding the Perceived Influence of Childhood Cancer and NF1 on the Parents' Marital/Partner Relationship: A Descriptive Study

To explore whether the stress associated with having a child with cancer or NF1 is perceived to impact the communication between partners.

To explore whether positive dyadic coping (joint decision making, joint problem solving, sharing responsibilities) is perceived to have strengthened the marital relationship/partnership since the child s diagnosis with cancer or NF1.

To describe the time points and events during the child s illness trajectory when the relationship becomes most stressed and/or strengthened.

To compare the perceptions of various subgroups in the sample, (e.g. parents who score either high or low on a marital stress scale, mothers versus fathers) statistically or qualitatively as the distribution of the characteristics of the sample allow.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Health Care Decisions for Female Adolescents: The Role of Mothers and Daughters in Decision Making	NCT00807898	Cervical Cancer		13 Years -	University of Louisville
Health Care Decisions for Female Adolescents: The Role of Mothers and Daughters in Decision Making	NCT00807898	Cervical Cancer		13 Years -	University of Louisville
DAMES: Daughters And MothErS Against Breast Cancer	NCT00630591	Breast Cancer	Standardized Ma... Independent Tai... Partner-Assiste...	21 Years -	Duke University
Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)	NCT01702922	Parents of Chil... Parents of Chil... Parents of Chil...		18 Years -	National Institutes of Health Clinical Center (CC)
Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)	NCT01702922	Parents of Chil... Parents of Chil... Parents of Chil...		18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for mother

Every month we try and update this database with for mother 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 mother

Every month we try and update this database with for mother 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 mother 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.