Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Quality of Life

* Brief Index of Sexual Functioning for Women questionnaire
* Quality of life questionnaire (EORTC QLQ-BR23)
* Partnership questionnaire (partnerschaftsfragebogen; PFB)
* Short interview about their sexual intimacy

Medical questionnaire

Dubuc Myriam

Sexual health is one of the relevant parameters for assesing the quality of life.

Improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase.

The purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.

We use a quantitative methodology to assess quality of female sexual life, quality of life and quality o relationship with validated scientific questionnaires.

The sexual and emotional intimacy will be explored by semi structured interview, not mandatory for patients.

Metastatic Breast Carcinoma and Women Sexual Quality of Life

Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life

Quality of sexual life will assessed by BISF-W (Brief index of sexual functioning for women) questionnaire

Quality of life will assessed by quality of life breast cancer module questionnaire (QLQ-BR23) (Hinz et al, 2014)

Quality of Relationship of the couple will assessed by partnership questionnaire (PFB). 30 items making up a global scale measuring the Quality of relationship (PFB).Quality of relationship (PFB) score can be obtained with the following equation: PFB = (30 - Quarreling) + Tenderness + Togetherness/communication ( Rossier et al, 2006).

Patients will be interviewed by open-ended questions face to face concerning their Sexual and emotional intimacy.

Institut de Cancérologie de Lorraine

Respiratory Tract (Lung and Bronchial) Diseases

Anxiety Disorders

Depressive Disorder

Depression

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients in the intervention group receiving the 8 weeks MSC intervention sessions.

No interventions except conventional care were performed for the control group.

Patients in the intervention group had access to conventional care, in addition to receiving the 8 weeks MSC intervention sessions. The intervention was provided by trained nurses, including one researcher and one MSC therapist. The intervention is mainly out-of-hospital intervention, supplemented by short-term in-hospital intervention. Among them, the first and second weeks of the intervention project in the hospital phase focus on guiding the research subjects to understand the content of mindful self-compassion and emotions, and carry out basic mindful self-compassion training; the content of the 3-8th week of the intervention program outside the hospital, Focus on the maintenance of mindful self-compassion training and the promotion of mindful life. Each face-to-face group contact lasted about 1 hour, depending on the complexity of the patients' problems.

MSC intervention

The incidence and mortality of lung cancer ranks first among cancers in the world, and the five-year survival rate of lung cancer patients is only 15% to 30%. Lung cancer patients bear a great psychological pressure, prone to anger, isolation, anxiety, depression, self-esteem and other psychological problems. The incidence of psychological disorders in lung cancer patients was 24.2 to 73.4%. A diagnosis of cancer not only causes physical and mental pain to the patient, but also has a huge impact on the family and their caregivers. As patients'primary coping resources, caregivers have to bear both physical and mental pressures. Therefore, it is worth to attention the mental health of lung cancer patients and their caregivers.

With the further deepening of self-concept research and the integration of Buddhist thought and psychology, the new concept of 'self-compassion' was proposed and developed. Self-compassion means that individuals treat themselves like their friends, with a friendly and tolerant attitude; maintains an objective and rational attitude towards the individual's own situation at all times; thinks that pain is a common experience shared by others, and everyone should be understood and sympathized. At the same time, self-compassion not only includes acceptance and affirmation of oneself, but also connects oneself with others, advocating that one should sympathize with oneself as sympathizing with others, providing the possibility of emotional connection between patients and their caregivers. Therefore, the study of mindfulness and self-compassion is expected to provide a reference for improving the dyadic mental health of lung cancer patient-caregiver dyads in China.

Mindfulness Self-Compassion (MSC) is a positive psychology intervention method that covers the concept of self-compassion developed by Neff and Germer on the basis of Mindfulness-based Stress Reduction. MSC is a 2.5-hour weekly, 8-week standardized training course. Some studies have shown that MSC can promote the emotional health of cancer patients and buffer their mental symptoms.

To sum up, the current mindfulness self-compassion training program has been applied to some cancer patients, and shows that the intervention has a positive effect, while the research in China has only been initially applied in the student population, and has not been applied in the field of cancer. Therefore, for lung cancer patient-caregiver dyad, the researchers can learn from the experience of mindfulness self-compassion training and develop a dyadic mental health intervention program based on Chinese condition. The current study aims to verify the effect of the dyadic mindfulness self-compassion intervention program for lung cancer patients and their caregivers, and explore its mechanism.

The study was a single blind, follow-up, randomized, controlled trial. Researchers recruited subjects from two general tertiary hospitals in Changsha, Hunan province, China. And the whole trail was on the basis of the CONSORT statements. The two hospitals provided similar conventional care for lung cancer patients. Study procedures were approved by the institutional review boards of all participating centers before data collection began. All patients were screened by researchers for eligibility and then enrolled in the study if eligible and if the provided consent.

Potential eligible participants were identified by researchers according to medical records at the colorectal surgery unit in each hospital. The participants were recruited with informed consent, and researchers explained the study purposes, procedures, benefits, and risks involved orally. The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list. A sequentially numbered and opaque , sealed envelope system was used by a non-investigator. The generated random numbers were put into consecutively numbered and opaque sealed envelopes. When enrolling and randomising a new participant, the enrolling investigators opened the sealed envelope after participant's name was written on next available envelopes; the enrolling investigators were blinded to the trial design and study hypotheses.

The researcher will recruit 74 lung cancer patient-caregiver dyads and randomly divide them into 2 groups: the control group, the dyadic intervention group. Among them, patients in the control group and caregivers received routine psychological care programs; patients in the intervention group had access to conventional care, in addition to receiving the 8-week dyadic MSC intervention sessions. The intervention was provided by trained nurses, including one researcher and one MSC therapist. The researcher was regarded as primary leader of the intervention sessions. The leader informed patients of the schedule for each session using the educational manual'Caring for ourselves, we are together' (developed by psychologists, nursing managers, experienced MSC therapist, oncology Nurse, and researchers).

The MSC techniques include body scanning, breathing meditation, sitting meditation, walking meditation, loving-kindness practice, and self-compassion writing expression. Intensive training once a week, 1 hour each time, encourage students to use 15-20 minutes a day to learn these skills, the total training time per week is 2.5 hours. The intervention is mainly out-of-hospital intervention, supplemented by short-term in-hospital intervention (1-2 weeks, adjusted according to the patient's hospital stay). The in-hospital stage focuses on guiding the research subjects to understand the content of mindful self-compassion and emotions, and conduct basic mindful self-compassion training; the outside of the hospital focuses on the maintenance of mindful self-compassion training and the promotion of mindful life.

Data were collected by a research assistant who was blind to the study design and allocation of participants. At baseline, before randomization, sociodemographic and clinical characteristics were collected from medical records and personal interviews. The two groups of participants completed surveys after each follow-up via face to face interviews at baseline (T0) and immediately after intervention (T1). The next two evaluations were performed at 1-month (T2) and 3-months (T3) after intervention via telephone contact.

Patients in the intervention group had access to conventional care, in addition to receiving the follow-up MSC intervention sessions. The intervention was provided by trained nurses, including one researcher and one MSC therapist. The researcher was regarded as primary leader of the intervention sessions. The leader informed patients of the schedule for each session using the educational manual 'Caring for ourselves, we are together' (developed by psychologists, nursing managers, experienced oncology nurses, and researchers).

No interventions were performed for the control group participants during the study. However, these patients received conventional care in the oncology departments according to the two hospitals' similar nursing guidelines.

Potential eligible participants were identified by researchers according to medical records at the oncology departments in each hospital. They were recruited with informed consent, and researchers explained the study purposes, procedures, benefits, and risks involved orally. The participants were then randomly allocated to the intervention or the control group according to a computer-generated block randomization list. The generated random numbers were put into consecutively numbered and opaque sealed envelopes. When enrolling and randomising a new participant, the enrolling investigators opened the sealed envelope after participant's name was written on next available envelopes. A sequentially numbered and opaque , sealed envelope system was used by a non-investigator. Additionally, all data collection was conducted by another research assistant who was blind to the study design and allocation of participants.

Effects of MSC Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers

Effects of Mindfulness Self-Compassion Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers: a Randomized Controlled Trial

The process of data collection cost a lot of human and material resources, some of the data was privacy information of participants, and so on. Considering this, it is improper to share these data.

Patient Health Questionnaire 2-item Depression Screen (PHQ-2) is used to initially screen the high-risk groups of depression. The score of each item ranges from "0 means no at all" to "3 points means almost every day". The total score is equal to the sum of the items is 6 points, and 3 points or more can be considered as depressed. . PHQ-2 has good reliability and validity in the screening of depression in patients with cardiovascular diseases. Cronbach's α coefficient is 0.809, and the test-retest reliability coefficient is 0.882.

Generalized Anxiety Disorder-7 (GAD-7) is used to screen for Generalized Anxiety. There are 7 items in total. It is scored from 0 (never) to 3 (almost every day). , The higher the score, the more serious the anxiety. According to Spitzer's assessment of GAD-7 scale, 5 is divided into the cut-off value of symptom-positive samples.

The Self-compassion Scale has good adaptability in both healthy people and patients with chronic diseases. The scale contains 6 subscales of self-tolerance, self-criticism, universal humanity, loneliness, mindfulness and over-identification, with a total of 26 items. Each item uses a Likert 5-level score, ranging from "never" to "always". The score is 1 to 5, and the total score is 26 to 130. The three dimensions of self-criticism, loneliness, and over-identification use the reverse scoring method. The Cronbach coefficient of the scale is 0.84, and the test-retest reliability is 0.89.

Central South University

Principal investigator

Following completion of the virtual consent/baseline visit and the virtual education visit, dyads will work through content of self-guided workbook. Every two weeks, participants will receive a check-in email and/or text message from study staff to assess their adherence and respond to questions or concerns.

The workbook contains 3 modules. To complete the workbook in six weeks (one module every 2 weeks), it is recommended that a dyad schedule at least three 30-minute blocks of time each week. Dyads are asked to work through the modules in order and encouraged to set a pace that works for them.

Self-Guided PEPP Intervention Workbook

Self-Guided PEPP Education Workbook

Noel M Arring, DNP, PhD, RN

Carrie K Lafferty, PhD

Noel M Arring, DNP,PhD,RN

The purpose of this study is to compare two Psychosexual Educational programs for women who have completed treatment for breast or gynecological cancer and their partners in preparation for a well-powered phase III study. The investigators plan to enroll 30 dyads in a 2-arm pilot randomized controlled trial (RCT).

The primary aim will be to assess the preliminary efficacy of the Psychosexual Educational Partners Program (PEPP) on sexual communication.

The Psychosexual Educational Partners Program (PEPP) is a two-arm pilot randomized controlled trial that will compare two approaches to a self-paced, workbook-based intervention. PEPP was designed to enhance intimacy among breast and gynecological cancer survivors and their partners by improving sexual communication. The primary aim of the study is to assess the preliminary efficacy of the revised PEPP intervention on sexual communication. Secondary aims include assessing the preliminary efficacy of PEPP on self-efficacy to communicate about sex and intimacy among cancer survivors; and evaluating adherence, acceptance and adverse events within each study arm.

The intervention is six weeks long and does not require any in-person visits. If a breast or gynecological cancer survivor is determined eligible, they will be educated on the purpose, requirements, and procedures. If interested, participants will be emailed the consent form and will schedule a virtual consent/baseline visit that will include their partner. After consent is obtained from both partners, the dyad will be randomly assigned to a study arm and given study numbers. Both members of the dyad will complete online surveys at the virtual baseline visit. The PEPP workbook will be sent to the participants' address and a virtual education visit will be scheduled. At this second virtual visit, both members of the dyad will receive education about their study arm and a start date will be agreed upon for week 1. Beginning week 1 and continuing through week 6, dyads will work through the PEPP workbook which contains three modules. Participants will receive a scheduled email and/or text check-in message from study staff every two weeks to coincide with the end of each module. Messages will provide a link to a brief survey to assess adherence and respond to any participant questions or concerns. Online surveys will be repeated and adverse events will be assessed at week 6.

This is a two-arm randomized controlled trial

Eligible participants must be female breast or gynecological cancer survivors and their intimate partners.

Psychosexual Educational Partners Program (PEPP)

Psychosexual Educational Partners Program (PEPP): Randomized Phase II Trial

This is a small pilot study and as such, data will be thoroughly interrogated. However, if an investigator feels there are unanswered questions or wishes to add to a larger dataset, we would entertain all data-sharing requests for de-identified data as appropriate.

The preliminary efficacy of the revised PEPP intervention on sexual communication among dyads. The DSC is a single-dimensional 13-item scale that measures sexual communication between partners on a 4-point Likert scale, disagree strongly to agree strongly. Possible scores range from 13-52 with higher scores indicating better sexual communication.

The SECSI is a is a 10-item scale that measures self-efficacy to communicate about sex and intimacy among women treated for cancer. Participants respond using a 4-point Likert scale, strongly agree to strongly disagree. Possible scores range from 0-30 with higher scores indicating greater self-efficacy to communicate with a partner about sex and intimacy after cancer treatment.

The number of PEPP modules completed by participants divided by the number of participants multiplied by 3 (the total number of modules).

Evaluate the adverse events in participants randomized to each study arm.

The University of Tennessee, Knoxville

Associate Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Sensate Focus Exercises aim to help couples be more present with one another through talking and through touch.

Sensate Focus exercise

Don S Dizon, MD

This project seeks to help patients address and improve intimacy at the end of treatment for breast or prostate cancer. It is intended to address the needs of cancer survivors, broadly defined as paftients and their loved ones or caregivers facing a cancer diagnosis. While we know sexual health is impacted by the diagnosis and treatments for cancer, we also are increasingly aware that partners and spouses are also impacted by the experience. Yet, there are no evidence based interventions that focus on the couple's recovery after the initial cancer experience.

The objective of this study is to look at the impact of an intimacy intervention at the completion of cancer treatment for couples facing breast or prostate cancer. We will enroll patients and their intimate partners in this study in two phases. In the first phase, couples will receive sensate focus homework, explained to them at a standard survivorship care visit (SCV) by a study nurse practitioner (NP). The objective in the first phase is to see if this is something feasible by looking at how many use sensate focus homework in 6 weeks. If it is not feasible, we will rework the study based on what we learned. However, if it is feasible, we will reopen the study to a larger group and employ a random assignment to an SCV with or without sensate focus homework. This phase will give us evidence of efficacy that we will use to propose a larger randomized trial, potentially in the National Cancer Institute system.

Participants will be asked to answer questionnaires at baseline, 6 weeks, and then at 12 weeks during phase 2. Those who complete treatment at 12 weeks will be re-contacted 6 months after protocol enrollment for an optional end of treatment interview to assess what they thought of the intervention, including sensate focus homework itself and the timing.

The National Comprehensive Cancer Network (NCCN) identifies sexual dysfunction as a major issue facing cancer survivors (defined broadly as patients and their caregivers, starting at the point of the index cancer diagnosis). It is well known that a cancer diagnosis and treatment negatively impacts partner relationships and quality of life (QOL) (for both patient and partner). Despite this, only about a third of patients seek assistance, and the figures regarding assistance from caregivers is lacking.

The etiology of sexual dysfunction is multifactorial and includes problems with sexual desire and pleasure, hormonal deficiencies, vaginal and penile alterations related to treatment, delayed or absent orgasm and/or ejaculation, pain with intercourse, erectile dysfunction, and psychological problems such as anxiety, depression, and changes in body-image. Unfortunately, interventions have largely focused on ways to improve sexual function, although even these are limited. Additionally, clinicians are often reluctant to address sexual function with their patients due to their lack of training and discomfort in engaging in these conversations. Given the well-documented burden of sexual dysfunction, there is a compelling need to develop interventions to address sexual health, for both patient and partner while encouraging clinicians to discuss sexual health issues.

Beyond the issues of the individual, couples and families are also impacted by cancer treatment. A wide body of literature shows that a cancer experience can add additional demands on couples, especially in the realms of communication, intimacy, and sexuality. A small study of 8 couples where the female partner had breast cancer identified three themes of significance: (1) disconnection from the relationship, due to the woman prioritizing her own needs before those of the partner or of them as a couple; (2) renegotiation of the couple relationship; and (3) need for support for negotiating going forward as a couple. Unfortunately, they also comment on the limited evidence-based interventions to aide this transition, particularly for the couple.

In this project, the investigators will build upon standard procedures to address intimacy at the end of curative intent therapy through sensate focusing exercises (SF). SF will be delivered during a face-to-face survivorship visit using a trial-specific script.

The project will proceed in two phases. During phase 1, the investigators will assess feasibility by conducting a prospective pilot study. During phase 2, the investigators will conduct a randomized trial comparing survivorship care with or without sensate focusing.

This project has the potential to substantially enhance the care of survivors. By implementing such an intervention to improve sexual function, we aim to enhance the QOL and intimacy of cancer survivors.

An Intimacy Intervention for Couples Completing Breast or Prostate Cancer

Proportion of couples enrolled in phase one who are practicing sensate focus at 4 weeks

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metastatic Breast Carcinoma and Women Sexual Quality of Life	NCT03408769	Metastatic Brea...	Medical questio...	50 Years - 70 Years	Institut de Cancérologie de Lorraine
Effects of MSC Intervention on the Dyadic Mental Health of Lung Cancer Patients and Their Caregivers	NCT04795700	Depression, Anx...	MSC interventio...	18 Years -	Central South University
Psychosexual Educational Partners Program (PEPP)	NCT06253182	Breast Cancer Gynecologic Can... Sexual Dysfunct... Partner Communi...	Self-Guided PEP... Self-Guided PEP...	18 Years - 99 Years	The University of Tennessee, Knoxville
An Intimacy Intervention for Couples Completing Breast or Prostate Cancer	NCT04221607	Sexual Dysfunct... Breast Cancer Prostate Cancer	Sensate Focus e...	18 Years -	Brown University

Spots Global Cancer Trial Database for intimacy

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

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