Behaviors and Mental Disorders

All Conditions

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Alcohol Drinking

Mouth Neoplasms

Drinking Behavior

Oral Cancer

Lip and Oral Cavity Cancer

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

MAPS+ (Motivation and Problem-Solving Plus):

Counseling using specific treatment approach that focuses on combined smoking cessation and the reduction of at-risk alcohol use.

MAPS (Motivation and Problem-Solving):

Counseling treatment approach with a focus on smoking cessation.

7 counseling calls where quit date set on first counseling call; then counseling calls on quit date, 3-5 days after quit date, 7-10 days after quit date, 15-30 days after quit date, 45-60 days after quit date, and 90 days after quit date, each taking about 15 to 30 minutes to complete.

Telephone Counseling

4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete.

Telephone Assessments

Lorna McNeill, MPH,PHD

Objectives:

1. Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
2. Assess MAPS and MAPS+ effects on treatment mechanisms (increased self-efficacy, decreased temptations/craving, decreased stress and negative affect) and the role of those mechanisms in mediating MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
3. Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.

Participants for this study will be recruited mainly through media advertisements (such as TV, radio, newspapers, magazines, etc.).

If you are interested in participating in this study, you will be asked to provide demographic information, such as your name, telephone number, and address. You will then be mailed a packet, which will include a copy of this informed consent document, self-help reading materials, and a guide to answering the questionnaires.

Within about 2 weeks after you have received your packet, you will be interviewed by a research staff member by phone. You will be given detailed information about this study as part of the consent process. This is a telephone counseling study. Please read this copy of the consent very carefully. When the research staff member calls you in about 2 weeks, he or she will review this consent form with you. You should ask any questions you have about the consent or the study, and discuss any concerns you have with the research staff member. After discussing the consent and the study with the research staff member, you will be asked if you have read and understood the consent, and asked if you agree to participate in this study. Your consent to participate in this study will be tape recorded. This is so researchers can verify (know) that you have freely consented to participating in this study. You should keep this copy of the consent, and you may ask questions about it and/or the study at any time.

If you agree to participate, you will then go over several questionnaires with the interviewer. You may be asked questions about your living situation, mood, depression, anxiety, sleeping habits, appetite, smoking and alcohol use habits, social status, finances, job, physical activity, and support base (family and/or friends). Then a quit date will be set as well as the first telephone counseling call. This interview may take a total of about 1 hour to complete.

After this interview, participants will be randomly picked (as in the toss of a coin) to be in one of 2 groups. One group will receive standard quit-smoking counseling to help decrease their risk of cancer. The other group will also receive counseling, which will focus on decreasing the risk of getting cancer by decreasing smoking and alcohol use.

Your counselor will be contacting you to set up your first counseling call. You will receive a total of 7 counseling calls. You will discuss the timing of the counseling calls with your counselor based upon when it is felt to be most beneficial for you. Depending on which group you are in, you will be counseled on strategies for quitting smoking and/or decreasing alcohol use to help decrease your risk of cancer. These calls will take about 15 to 30 minutes each to complete.

At Weeks 12, 26 and 52, you will be interviewed by telephone by a research staff member, who will cover the same information as before. These evaluation (assessment) calls will take about 30 minutes each to complete. You will receive a total of 4 assessment phone calls. You will receive a total of 11 calls (including the counseling and assessment calls) over about a 12-month period of time.

Your counseling calls (not the assessment calls) will be tape recorded. You will be reminded before each counseling call that it will be taped recorded. This is so researchers can make sure that correct procedures are being followed. Only the study staff will be allowed to listen to these tapes. Your identity will be kept secure and confidential. These tapes will be erased when this study has ended.

Your participation in this study will be over after the assessment call at Week 52.

This is an investigational study. Up to 370 participant will take part in this multicenter study. None will be enrolled at M. D. Anderson.

Combined Treatment for Tobacco and Alcohol Use in Puerto Rico

Oral Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Lung Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.

Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.

For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.

Unsigned note to provider about cessation medication prescription

Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.

Proactive Telephone Counseling from VA Quitline

Steven B. Zeliadt, PhD MPH

This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.

This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.

Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

The investigators anticipate publishing the findings alongside other similar trials funded by NCI through the Smoking Cessation within the Context of Lung Cancer Screening (SCALE) collaboration, with journals that will likely require concurrent publication of de-identified datasets.

The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records

Provider surveys will assess acceptance of and satisfaction with the proactive care approach among primary care clinicians referring Veterans for lung cancer screening

Costs of implementing the proactive care approach will be monitored and analyzed, including intervention staff effort, provider time, costs of telephone counseling, and pharmacotherapy costs

Patient surveys will assess satisfaction with VA Quitline telephone counseling

Surveys will assess patient motivation to quit smoking

Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective

Surveys will assess patients' self-efficacy for quitting smoking

Fred Hutchinson Cancer Center

VA Office of Research and Development

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Depression

Depressive Disorder

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Fallopian Tube Neoplasms

Behavioral Symptoms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Quality of Life

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Weekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided.

Lists of professional resources and referral recommendations will be provided.

Weekly phone calls lasting about 30 minutes.

Usual Care

Eileen H. Shinn, PhD

The goal of this behavioral research study is to find a quick and effective way to identify depression in patients with ovarian, peritoneal, or fallopian tube cancer. Another goal of this study is to compare an intervention program with "enhanced" standard care to see which may be more effective in improving quality of life for these patients.

Study Participation:

If you agree to take part in this study, you will fill out a questionnaire, complete an interview (called a SCID interview), and information will be collected from your medical record.

For the questionnaire, you will answer questions about your mood, ability to cope with cancer, thoughts about cancer, and demographic information (such as your age and race). It should take between 30 and 40 minutes to complete the questionnaire.

For the SCID interview (which may be conducted during your routine visit at M. D. Anderson or by telephone), a trained interviewer will ask you questions related to the degree of depression you may be experiencing. It should take between 30 and 40 minutes to complete the SCID interview. The study staff will also show you TAT cards, which are standardized psychological testing cards, and ask you to give responses to the cards.

Information collected from your medical record will include the cancer stage, if the disease has gotten worse, treatment, and side effects. This information will help researchers learn how specific treatments affect patients.

* You may also be asked to have an informal interview on your personal experience about matters not related to depression. Information learned from this interview may need to be addressed in order to help you cope with your personal cancer experiences (such as communicating with your study doctor and study staff, financial counseling, and spiritual guidance).
* If you are not found to be eligible for the intervention group, you will be contacted again in 4 months to complete a second questionnaire and SCID interview. Both will be the same as the first questionnaire and SCID interview, except that the questionnaire will have additional questions about the type of psychosocial help you may have received outside of this research study during the 4-month period.

Study Group Randomization:

If your answers to the first questionnaire show that you might benefit from psychosocial support, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups (an intervention group or an enhanced standard care group).

Intervention Group:

If you are assigned to the intervention group, you will receive intervention plus enhanced standard care that is described below. For the intervention, you will have 10 telephone calls by a trained psychologist under the supervision of a licensed psychiatrist. The psychologist will discuss with you and teach you cognitive-behavioral techniques. These techniques will show you ways to relax, how to schedule physical activities, and how to identify and counter negative thoughts. You will also receive a journal to write down ideas on how to practice fighting depression. These intervention calls will last about 30 minutes each time, and will occur once a week (almost every week).

Standard Care Group:

If you are assigned to the enhanced standard care group, you will be informed of the results of the analysis of your first questionnaire and provided with a list of professional resources and referral recommendations for psychosocial counseling. Your treating doctor and/or regular doctor will also be informed of these results as well. After 4 months in this group, you will be able to receive the intervention as described above.

Additional Information:

In order to check for quality control (to see if the intervention and SCID interview have been appropriately done), a random sample of telephone counseling sessions (from the intervention group) will be tape recorded, and a random sample of interviews (the SCID interviews) will be tape recorded and/or videotaped. Before any information is tape recorded and/or videotaped, you will be asked for your permission.

The tape recording and/or videotaping will be done by members of study staff. No identifying information (such as your name and medical record number) will be recorded on the audiotape and/or videotape. The audiotape and/or videotape will only be labeled with study ID numbers.

Length of Study:

If your answers to the first questionnaire do not show that you might benefit from psychosocial support, your participation will be over (in about 4 months) after you have completed the follow-up questionnaire and SCID interview.

If you are assigned to the intervention, your participation will be over (in about 4 months) once you have completed the 10 weekly intervention sessions.

If you are assigned to the standard care group, your participation will be over in about 4 months, or about 8 months if you are able to also take part in the intervention once you have completed your participation in the standard care group.

This is an investigational study. Up to 588 patients will take part in this study. All will be enrolled at M. D. Anderson.

Depression Treatment and Screening in Ovarian Cancer Patients

Lance Armstrong Foundation

Participants given an activity tracker at the given an accelerometer at each visit. Participants instructed in use of a smartphone application at the baseline visit.

Participant emailed electronic newsletters to read that may help participant be more physically active.

Research staff provides telephone counseling to participant and partner biweekly during weeks 1-8 (weeks 1, 3, 5, and 7), and monthly during weeks 9-16 (weeks 11 and 15).

Study visits performed 2 times (1 time at the beginning of the study, and 1 time 16 weeks after beginning the study).

Participants complete questionnaires 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.

Participants invited to take part in a final focus group sometime after the 16-week visit.

Participants sent electronic newsletters throughout the study that may help participant be more physically active.

Study visits performed 2 times (1 time at the beginning of the study, and 1 time 16 weeks after beginning the study).

Participants complete questionnaires 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.

Participants invited to take part in a final focus group sometime after the 16-week visit.

Group 1 - Intervention: Participants given an accelerometer at each visit. Participant wears the accelerometer for 7 days.

Group 2 - Newsletters: After completing the 16 week visit, participant given an activity tracker.

Activity Tracker

Group 1 - Intervention: Participant given smartphone application baseline visit to track physical activity, connect with participant's partner to share information about participant's physical activity, and provide support to partner to be more physically active.

Group 2 - Newsletters: After completing the 16 week visit, participant given instruction in the use of a smartphone application.

Smartphone Application

Participants complete questionnaires about feelings, moods, motivation for physical activity, any social support received from others, the neighborhood participant lives in, and other physical activity-related topics. Questionnaires completed 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.The questionnaires should take about 45 minutes to complete.

Questionnaires

Participants invited to take part in a final focus group. Focus group takes place sometime after the 16-week visit. Focus groups/interviews are audio recorded.

Focus Group

Participant emailed electronic newsletters to read that may help participant be more physically active.

Electronic Newsletters

Research staff provides telephone counseling to participant and partner biweekly during weeks 1-8 (weeks 1, 3, 5, and 7), and monthly during weeks 9-16 (weeks 11 and 15).

Larkin L. Strong, PHD

The goal of this research study is to learn if enrolling in a program with a partner that involves monitoring each other's physical activity and providing support to one another can help both participants be more physically active.

Study Groups:

If you are found to be eligible to take part in this study, you and your partner will be randomly assigned (as in a flip of a coin) to be in 1 of 2 groups after you complete the first in-person visit. You will have an equal chance of being in any group.

If you are assigned to Group 1, the following tests and procedures will be performed:

* You will wear an activity tracker that you will be given at the baseline visit. The activity tracker is a small device worn on your wrist that records how many steps you have taken.
* You will be instructed in the use of a smartphone application at the baseline visit which you will use to track your physical activity, connect with your partner to share information about your physical activity, and provide support to your partner to be more physically active.
* You will have 6 counseling calls over the telephone throughout the study with a trained counselor and your partner.
* You will be emailed electronic newsletters to read that may help you be more physically active.

If you are assigned to Group 2, you will be sent the newsletters that may help you be more physically active and upon completing the16 week visit, you will be given an activity tracker and instruction in the use of a smartphone application.

Study Visits:

You will visit MD Anderson Cancer Center, Windsor Village United Methodist Church, or a community site 2 times (1 time at the beginning of the study, and 1 time 16 weeks after you begin the study). Each visit should take about 90 minutes. The following procedures will be performed:

* Your blood pressure will be measured. If you have a blood pressure reading higher than 140/90 mm Hg, you can participate in this study only with a clearance letter from your physician or nurse practitioner. If your blood pressure reading is higher than 180/120 mm Hg, the study staff must contact 911 and have EMS come and treat you due to your blood pressure being dangerously high. You have the right to refuse EMS services but study staff are still required to contact 911 immediately as a precaution. You will not be able to continue in the study until the clearance letter has been received.
* You will complete questionnaires about your feelings, moods, your motivation for physical activity, any social support you may receive from others, the neighborhood you live in, and other physical activity-related topics. The questionnaires should take about 45 minutes to complete. For the 2nd visit, you will have the option of completing the questionnaire online before your scheduled visit. This may reduce the length of your 2nd visit.
* You will be asked about your diet (for example, what you eat and drink each day).
* Your height, weight, and waist and hip circumference will be measured. To measure your waist and hip circumference, you may be asked to lift your shirt to expose your stomach area and lower your pants to expose your mid-hip area. The height, weight, and waist and hip circumference measurements should take about 10 minutes and will be performed in a private area.
* Your heart rate variability (HRV) will be measured with a wrist watch and a belt band. To measure your HRV, you will be asked to lift your shirt to expose your upper stomach area (at the breast bone). The band will be damp and should make firm contact with your skin. °You will wear the device for 5 minutes while it records your HRV as you sit quietly.
* You will be given an accelerometer at each visit. You will wear the accelerometer for 7 days and then return it in an pre-addressed envelope provided to you. An accelerometer is a small device that is worn on your hip that measures the amount of physical activity you do.

At 8 weeks after you begin the study, you will answer some questions either over the phone or through an online survey. The questions will cover the same topics as for the in-person visits. This should take about 30 minutes to complete.

All participants will be invited to take part in a final focus group. This focus group will take place sometime after the 16-week visit. You will be asked what you think about the study, including what you liked, did not like, and how you think it could be improved. If you want to provide this feedback but you cannot come to the focus group, you may provide feedback in another way (such as a phone interview or you could meet the study staff at the church or a community setting). These focus groups/interviews will be audio recorded. Your name and identifying information will be deleted from the recording before being transcribed (typed out) by an outside party. This should take about 90 minutes. The digital audio files will be destroyed within 10 years after publication.

Length of Study:

Your participation on this study will be over after you complete the final focus group visit.

Additional Information:

If you are assigned to Group 1, you may be contacted by phone or mail while you are taking part in this study to remind you about study visits, study procedures, and counseling calls.

You will be asked to give the names and contact information of family members and/or friends for the study staff to contact in the event they cannot reach you first.

The counseling calls for Group 1 will be recorded to monitor counseling procedures.

You will also be asked to participate in two optional procedures. First, you will be asked to "friend" your counselor on the mobile application so that the counselor can monitor your steps in preparation for the counseling calls. Second, you will also be asked to share your user ID and password for the activity tracker. This will enable research staff to download your physical activity data that will help staff to understand how much participants are using the device and how many steps they are taking. These data will only be examined during the 16-week study period, and you will be instructed to change your password at the end of the study.

If the accelerometer is lost or stolen, you will not be responsible for the replacement cost, but you should tell the study staff right away.

You will be able to keep the activity tracker after the study is complete.

Your home address may be used to access public information about the area where you live. This is to help researchers learn about how your neighborhood encourages physical activity. The results from this study will only be reported as a group and you will not be identifiable from any products resulting from this study (such as research papers). Your home address will never be released or published in any form. Your address will be stored separately from other study data, and only the study chair will be able to see the data after the neighborhood information has been collected.

You may be contacted in the future to see if you would agree to take part in other research studies.

Women who are pregnant or thinking about becoming pregnant during the study period will no longer be able to participate. If you become pregnant during this study, please tell the study staff right away.

This is an investigational study.

Up to 64 participants will take part in this study. All will be enrolled at MD Anderson.

Using Social Networks to Promote Physical Activity in African American and Hispanic Women

Women's preferences for a physical activity (PA) promotion intervention determined by focus groups.

Study considered feasible only if recruitment and retention percentages reach the lower bound of the one-sided 90% confidence intervals of the target unless there are convincing arguments they can be improved sufficiently by modifying recruitment or retention strategies.

Uterine Cervical Neoplasms

Telephone counseling

Telephone interview

Lari B Wenzel, PhD

The purpose of the study is to:

1. Test the efficacy of psychosocial telephone counseling (PTC) for cervical cancer survivors, compared to usual care.
2. Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care.
3. Examine the longitudinal relationship between PTC associated modulations of quality of life (QOL) measures and biologic parameters (immune and neuroendocrine).

The incidence and mortality rates for invasive cervical cancer in minority, low-income, and less educated women exceeds that for white, higher income, and better educated women. In southern California the incidence and mortality rates for cervical cancer are nearly twice that of non-Latina white women. Our preliminary work supports and extends the extant literature, noting that quality of life can be significantly disrupted among cervical cancer survivors, with qualitative differences in how Latina women experience cancer survivorship. However, there is a paucity of literature on interventions designed to assist cervical cancer survivors manage illness-specific stress and improve health behaviors. Our current NIH-funded work suggests that a six session psychosocial telephone counseling (PTC) intervention can improve QOL and decrease psychological distress, with accompanying intervention-induced neuroendocrine and immune parameter modulations which may be related to disease endpoints. In primary support of these significant biobehavioral findings, the project herein proposes to accomplish the following Specific Aims:

1. Test the efficacy of PTC for cervical cancer survivors, compared to usual care.
2. Evaluate the longitudinal immune and neuroendocrine parameters in cervical cancer patients who have received PTC, compared to usual care.
3. Examine the longitudinal relationship between PTC associated modulations of QOL measures and biologic parameters (immune and neuroendocrine).

To achieve these aims the investigators will randomize patients ascertained through the two SEER cancer registries to PTC (N=125) or usual care (N=125), stratifying on English or Spanish language preference. Assessments will occur at baseline (9-20 months post diagnosis), and three and nine months post enrollment/baseline. Assessments will include evaluation of QOL (overall QOL, psychological distress, coping, social support, sexual functioning), health behaviors, neuroendocrine parameters dehydroepiandrosterone sulfate, growth hormone \[DHEA-S, cortisol, GH\] and immunologic parameters (natural killers \[NK\] cell activity, IL-5, interferon, human papillomavirus (HPV) E6/E7 peptides, IL-15, IL 10). This project has significant public health relevance for an important unstudied cancer survivor population, many of whom are poor and underserved. If effective, an intervention which could improve quality of life (QOL) and health behaviors, and enhance neuroendocrine and immune responses for women with cervical cancer could have significant implications toward disease recurrence or survival.

Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes

Stress, Immunity & Cervical Cancer: Biobehavioral Outcomes of a Randomized Trial

National Institutes of Health (NIH)

University of California, Irvine

Professor of Medicine

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Disease Attributes

20-30 minute structured conversation with breast cancer patient using Mini-AFTERc Manual

20-30 minute structured conversation following guidelines and instruction within the Mini-AFTERc 20 page manual

Mini-AFTERc

this consists of a 20-30 minute conversation about the general well-being of the patient with no specific reference to recurrence fears unless raised by the patient explicitly themselves

telephone call

Gerry Humphris, PhD

This is a controlled trial of the Mini-AFTERc intervention to reduce fears of recurrence in breast cancer patients. The sample will be collected in NHS Fife Breast Cancer Services (n=32). The intervention is a short telephone counseling service of 20 minutes delivered by the patient's breast cancer specialist nurse. Dependent measures consist of the ACCRE FoR 4 item measure and the EORTC Intervention overall satisfaction scale.

1. Background The majority of breast cancer patients completes successfully their treatment and therefore become survivors with some of them experience negative outcomes. One of the most prevalent unmet needs of the breast cancer survivors is Fear of Recurrence. Fear of Cancer Recurrence is defined as "the fear or worry that cancer will return, progress or metastasise". More specifically, 33% to 96% of the patients report FoR of cancer, while in 9% to 34% of these patients, the fear of recurrence is so detrimental even to their lives. Women of younger age with children have reported to have more severe FCR .

   Findings suggest that FoR can remain stable in cancer survivors five years or more after the diagnosis . Research has shown that cancer survivors that experience FoR, suffer from psychological and affective difficulties because of their initial worries of being cancer patients a second time. The most frequent of these negative outcomes are distress, stress-response symptoms and lower quality of life. Consequently, there is much interest of the researchers to focus on the factors that influence FoR in cancer patients, and the effect of FoR in survivors' quality of life . Less research has focused on interventions that can reduce fear of recurrence in cancer patients. The AFTER intervention is one of them, conducted a systematic intervention. The intervention was successful, since the study reported reduction in FoR at 6 month follow-up.

   The aim of the current study is to examine the effect of the Mini-AFTERc intervention, which is a shorter version of AFTER intervention, in reduction of fear of recurrence in breast cancer survivors with moderate level of FoR in comparison with a control group, where as the full AFTER intervention target patients with more severe FoR.
2. Research Question Whether the single-session intervention Mini AFTERc, delivered by a phone call, can reduce fear of recurrence in breast cancer patients with moderate level of fear in contrast with a control group.
3. Hypothesis The mini AFTERc intervention will reduce fear of recurrence in breast cancer patients with moderate level of fear, whereas FoR will not be reduced in the control group.
4. Methods and materials 4.1 Study design The study will be a quasi-experiment design implementing a single-session intervention which is aimed at reducing fear of recurrence in breast cancer patients with moderate level of fear, whereas FoR will not be reduced in the comparison group.

   4.2 Location of study The location of the study will be at NHS fife, Breast Cancer Unit of Queen Margaret Hospital, Dunfermline, where breast cancer patients can be treated and supported. Three experienced nurses of this unit will employ the Mini-AFTERc intervention.

   4.3 Participants Patients of NHS fife, Breast Cancer Unit of Queen Margaret Hospital, Dunfermline, in order to be included in the study, have to be breast cancer patients who have completed primary treatment and are worried about fear of cancer recurrence. An estimated number of participants are 34 patients to be able to answer successfully the research question. More specifically, the 17 patients of the treated group will receive a structured phone, based on the mini AFTERc intervention, whereas call the 17 patients of the control group will receive a standard phone call, which will not be a mini- After. A power analysis was conducted using NQueryAdvisor. A sample size of 17 in each group will have 80% power to detect a difference in means of 4 on the four item Fears of Recurrence Scale (the difference between the Control group mean: 25 and a Intervention group mean: 21) assuming that the common standard deviation is 4 using a two group t-test with a 0.05 two-sided significance level. Values obtained of SD and likely effect size from unpublished data held by Ozakinci and Humphris of breast and colorectal cancer patients and the original feasibility study conducted by Davidson and Humphris.

   All patients of the unit are welcome to participate. Participants will be invited in the study after the primary treatment, during a routine-care follow-up. The information sheet, the consent form and a pre-paid envelope will be provided in the patients. After they have completed the consent form, they will complete the questionnaire measure of FoR severity (ACCRE), in which they have to score above the cut-off to be included in the study.

   4.4 Measures and intervention The severity of FoR will be measured by employing the 4-item severity scale ACCRE at baseline and at 1-month follow-up. The second outcome measure will be the EORTC Satisfaction of Intervention measuring the overall satisfaction of the patients. The study will employ the Mini-AFTERc intervention, which is based on the six-session full AFTER intervention. The AFTER intervention was initially developed for head and neck patients to be targeted as patients with high level of FoR.

   The Mini-AFTERc intervention is a single-session, cognitive behavioral intervention based on the Leventhal's Self-Regulation Model and has been designed to be used with patients who report moderate levels of FoR. The aim of the intervention is to normalize and reduce FoR to a manageable level but still facilitate patients to be aware of the risks. The patients are enabled to be vigilant in symptoms change.
5. Data analysis The audio recording of the intervention consultation will be transcribed. Analysis of pre and post tests will be conducted by SPSS Predictive Analytics software v.21. The post-test will be subtracted from the pre-test to derive a change score. An analysis of variance will be conducted with a number of covariates (i.e. age and disease severity). The dependent variable will be the FoR ACCRE change score
6. Ethical approval

   The National Research Ethics Service will be contacted to prepare the NRES form and NHS Fife R\&D Governance forms as the study will be conducted with NHS Fife.

   Furthermore, we need to apply UTREC Ethics for the University of St Andrews, too.
7. Governance of study and support of participants The research project will be supervised by Professor Gerry Humphris. If needed, additional support to the patients will be provided by The Psychological Services at Edinburgh Cancer Unit, where Professor Humphris is a honorary clinical psychology consultant to the service and can pick up these referrals.

A Single Session Intervention For Fear Of Recurrence In Breast Cancer Patients

A Single Session Intervention For Fear Of Recurrence In Breast Cancer Patients (The Mini AFTERc): A Controlled Trial

University of St Andrews

Chair of Health Psychology

Breast Diseases

Skin Diseases

A letter sent to women reminding them that are coming due or overdue for a mammogram. It contains a reminder that their primary care provider (PCP) recommends mammography screening every 1-2 years. It urges them to call a special number to a study scheduler to get assistance scheduling a mammogram and is signed electronically by their primary care provider. Repeat "Booster" letters will be sent in subsequent years to those failing to get a mammogram.

A reminder letter (as in the 1st group) is sent. If a woman does not call in to schedule a mammogram within 2 weeks, a study scheduler will call her, remind her she is coming or is overdue, remind her that her PCP recommends screening every 1-2 years and offer to schedule a mammogram for her. Repeat "Booster" letters will be sent and repeat scheduler calls made in subsequent years to those failing to get a mammogram.

A reminder letter as above is sent first. If a woman does not call in to schedule a mammogram within 2 weeks, a second letter is sent along with a mammography educational booklet. The second letter also reiterates a reminder that her PCP recommends screening every 1-2 years, and offers a special number to call to schedule. If a woman does not schedule within 8-10 days, a counselor will call. The protocol script included tailored barriers counseling, correction of misinformation and motivational interviewing. Repeat "booster" letters will be sent and repeat counselors calls made in subsequent years to those failing to get a mammogram. techniques. Average calls last 20-30 minutes.

A letter sent to women reminding them that they are coming due or overdue for a mammogram. It contains a reminder that their doctor recommends mammography screening every 1-2 years; urges them to call a special number to a study scheduler to get assistance scheduling a mammogram and is signed electronically by their primary care provider. For women in the reminder letter only arm, who did not complete a mammogram within 12 months of the first reminder, a booster intervention (I.E. reminder letter) will be sent. The letter requests that a woman call in to schedule a mammogram, and reminds her that her PCP recommends she get one. Booster letters will be sent up to three times at annual intervals for those failing to get a mammogram

Reminder Letter

A reminder letter (as in the 1st group) is sent. If a woman does not call in to schedule a letter, 2 weeks later, a study scheduler will call her, remind her she is coming or is overdue, remind her that her PCP recommends screening every 1-2 years and offers to schedule a mammogram for her. For women in the reminder letter arm who did not complete a mammogram within 12 months of the first reminder, a booster intervention ( I.E.a reminder letter will be sent requesting that they call in to schedule a mammogram. The letter reminds her that her PCP recommends she get a mammogram. Those who do not respond within 7 days, will receive a scheduler call) will be repeated as necessary for up to 3 times.

Reminder Call

Reminder letter s as above is sent. If subject does not call in to schedule within 2 weeks, second letter is sent with mammography educational booklet. Second letter reiterates reminder that PCP recommends screening. Has number to call to schedule. If subject does not schedule within 2 weeks, counselor will call. Protocol script includes tailored barriers counseling, correction of misinformation and motivational interviewing techniques. For those who did not complete a mammogram within 12 months of the first reminder, a booster intervention will be repeated annually for up to 3 times as necessary.Booster is reminder letter with pamphlet stressing the 4 reasons why women need regular mammograms.

Counselor Call

Mary E Costanza, MD

Roger Luckmann, MD, MPH

This randomized study compares the effectiveness and cost-effectiveness of 3 proven methods of reaching out to women who are coming due for or who are overdue for a mammogram. The study originally embedded in a community healthcare plan and an associated community clinic, now accepts patients using the community clinic and 3 other health care plans. The study makes use of a complex computer driven reminder system.

The study also will examine ways to improve the efficiency and sequencing of the interventions by identifying patient factors associated with intervention effectiveness.

The randomized study compares three interventions. All eligible women are randomly assigned to 1 of 3 interventions. If they become 18 or more months from a prior mammogram, they will receive the intervention to which they were assigned.

The 3 arms are

1. RL ARM: (reminder letter) a control arm which consists of a reminder letter only that states when the last mammogram was, contains a standard recommendation from her primary care provider (PCP), and requests that the woman call a special number for help scheduling a mammogram.
2. RC ARM: (reminder call) a reminder letter as above, followed, if no response, by a reminder call from a study scheduler who offers to help schedule a mammogram.
3. ETTC ARM: (enhanced tailored telephone counseling call) a reminder letter as above, followed, if no response by a second letter, a mammography educational booklet and a second request to call a special number to schedule a mammogram. If no response, a study counselor/educator will call.

A complex computer-based tracking system identifies women coming due for a mammogram or those overdue for a mammogram. The system interfaces with the clinic database systems and stores information re age, telephone number, address, prior screening dates, primary care provider name, scheduling dates, etc. The system can generate reminder letters as appropriate.

The tracking system also interfaces with computer-assisted telephone script systems(CATI) which prompt the study scheduler or the study counselor to follow the protocol that is tailored to the individual patient.

The CATI system captures data from all calls, including how ready a woman is to schedule, the answers to a brief socio-demographic survey and in the counselor call script barriers and misinformation about mammography.

The computer system also interfaces with the radiology scheduling system so that study personnel can assist women in scheduling a mammogram during the phone call.

The primary outcome is the number of women in each arm getting a mammogram. This data will come from the clinic data base and the healthcare plan billing system.

Secondary outcomes include evaluation of the effect of booster or repeat interventions in women failing to respond to prior request for mammogram.

Promoting Breast Cancer Screening in Non-adherent Women

The outcome will be determined for each of the 4 years of intervention. But the main interest will be the outcome measured in the final intervention year because we believe this best illustrates the magnitude of intervention effect that could be achieved in future years.

We anticipate that fewer women who receive the ETTC call (Counselor call) will need repeat interventions compared with the women in the reminder call arm or the women in the reminder letter arm.

We anticipate that women who received a counselor (ETTC) call and who scheduled a mammogram on the call will have the highest completion rate compared to women who received a reminder call or a reminder letter.

The relative effectiveness and cost effectiveness of repeating reminders (letters, calls vs. counseling calls) in women who have not responded to a prior request(s) for completing a mammogram will be studied.

Reliant Medical Group

Fallon Community Health Plan

University of Massachusetts, Worcester

Study Principal Investigator

Digestive System Diseases

Carcinoma, Hepatocellular

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

Sorafenib

regular telephone counseling for compliance and advese event

telephone counseling

Ju Hyun Shim, MD. PhD

Jin-A Park

Sorafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects used as systemic treatment in patients with unresectable hepatocellular carcinoma.

Although sorafenib has demonstrated many clinical benefits in patients, its adverse cannot be ignores.

This drug occasionally causes severe adverse events (AEs), which include hand-foot skin reaction (HFSR), hypertension, diarrhea, anorexia, fatigue, weight loss, and so on. Although most adverse events are reversible, they can significantly impact a patient's quality of life and occasionally result in dose reduction or discontinuation of therapy Patients are also more likely to remain on treatment if they are guided over the difficult initial 4\~6wks of therapy during which time the development of adverse events following sorafenib treatment initiation are most likely to occur.

Patient education, proactive management and establishing and maintaining open communication between patients and the nurse are crucial to the effective management of these adverse events.

This study design is a randomized controlled trial and 64 patients will be randomized to one of 2 groups in a 1:1 ratio. 32 patients will be enrolled into the controlled group and the rest of 32 patients will be enrolled into the intervention group. The intervention group will be received the routine telephone calls of six times at intervals of once a week during 10\~15 minutes (from a well-trained nurse)

The purpose of this study is to confirm whether an effective intervention that telephone counseling and education by a nurse can increase drug compliance for patients with HCC who is taking Sorafenib and is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib after investigating patient satisfaction by "The Satisfaction with information about Medicines Scale(SIMS)" tool.

This study design is a randomized controlled trial and 64 patients will be randomized to one of 2 groups in a 1:1 ratio. 32 patients will be enrolled into the controlled group and the rest of 32 patients will be enrolled into the intervention group. The intervention group will be received the routine telephone calls of six times at intervals of once a week during 10\~15 minutes (from a well-trained nurse)

The purpose of this study is to confirm whether an effective intervention that telephone counseling and education by a nurse can increase drug compliance for patients with HCC who is taking Sorafenib and is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib after investigating patient satisfaction by "The Satisfaction with information about Medicines Scale(SIMS)" tool.

The Effect of Telephone Counseling on the Compliance and Satisfaction for Advanced HCC Patients Receiving Sorafenib

The Effect of Telephone Counseling on the Compliance and the Level of Satisfaction for Patients Receiving Sorafenib Due to Advanced Hepatocellular Carcinoma

SIMS is to use for developing individual educational program as a fundamental data that can be applied for patients taking Sorafenib

"Drug compliance for patients with HCC who is taking Sorafenib" as Assessed by MMAS-8 Score and compare "MMAS-8 score" between control group and intervention group.

Measurement is Scores range from 0 \[high adherence\] to 3\~8 \[low adherence\] )

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combined Treatment for Tobacco and Alcohol Use in Puerto Rico	NCT00570804	Smoking	Telephone Couns... Telephone Asses...	18 Years -	M.D. Anderson Cancer Center
Combined Treatment for Tobacco and Alcohol Use in Puerto Rico	NCT00570804	Smoking	Telephone Couns... Telephone Asses...	18 Years -	M.D. Anderson Cancer Center
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment	NCT03612804	Smoking Reducti... Tobacco Use Tobacco Smoking Tomography Lung Diseases Lung Neoplasms	Unsigned note t... Proactive Telep...	- 80 Years	VA Office of Research and Development
Combined Treatment for Tobacco and Alcohol Use in Puerto Rico	NCT00570804	Smoking	Telephone Couns... Telephone Asses...	18 Years -	M.D. Anderson Cancer Center
Depression Treatment and Screening in Ovarian Cancer Patients	NCT00515372	Ovarian Cancer Peritoneal Canc... Fallopian Tube ...	Telephone Couns... Usual Care	18 Years -	M.D. Anderson Cancer Center
Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment	NCT03612804	Smoking Reducti... Tobacco Use Tobacco Smoking Tomography Lung Diseases Lung Neoplasms	Unsigned note t... Proactive Telep...	- 80 Years	VA Office of Research and Development
Using Social Networks to Promote Physical Activity in African American and Hispanic Women	NCT03199196	Cancer Preventi...	Activity Tracke... Smartphone Appl... Questionnaires Focus Group Electronic News... Telephone Couns...	25 Years - 60 Years	M.D. Anderson Cancer Center
Stress, Immunity and Cervical Cancer: Biobehavioral Outcomes	NCT00496106	Ovarian Cancer	Telephone couns... Telephone inter...	21 Years -	University of California, Irvine
Depression Treatment and Screening in Ovarian Cancer Patients	NCT00515372	Ovarian Cancer Peritoneal Canc... Fallopian Tube ...	Telephone Couns... Usual Care	18 Years -	M.D. Anderson Cancer Center
A Single Session Intervention For Fear Of Recurrence In Breast Cancer Patients	NCT02357927	Fear	Mini-AFTERc telephone call	18 Years - 80 Years	University of St Andrews
Promoting Breast Cancer Screening in Non-adherent Women	NCT01332032	Breast Cancer	Reminder Letter Reminder Call Counselor Call	40 Years - 84 Years	University of Massachusetts, Worcester
The Effect of Telephone Counseling on the Compliance and Satisfaction for Advanced HCC Patients Receiving Sorafenib	NCT02564666	Hepatocellular ...	telephone couns...	20 Years - 90 Years	Asan Medical Center

Spots Global Cancer Trial Database for telephone counseling