Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

The intervention will consist of 6 weekly sessions of couples psychosexual counseling delivered via videoconferencing.

Couples will complete six weekly psychosexual counselling sessions. Each session will focus on areas relevant to sex therapy and sexual dysfunction in couples facing breast cancer (e.g. education, communication, body imagery, sensate focusing, and problem solving). Sessions will be one hour in length (Note: Session 1 will be 1.5 hours), during which couples will meet with a facilitator via videoconferencing.

Psychosexual Intervention

Karen Fergus, PhD

Diagnosis and treatment of breast cancer often leads to lower levels of sexual desire, decreased sexual arousal, painful intercourse, and difficulties achieving orgasm, and thus adversely impacts sexual functioning and intimacy. Despite the overwhelming evidence that many couples experience sexual distress following breast cancer, very few interventions have been designed exclusively to address these concerns. The purpose of this study is to develop and evaluate an online psychosexual program geared to the unique needs of couples experiencing sexual distress after breast cancer. This study will utilize a web-based approach, allowing couples to participate in the program from the privacy and comfort of their homes, and providing a resource to couples who may not otherwise be able to readily access support. Accordingly, this project has the potential for widespread positive impact for couples affected by breast cancer.

Many couples experience sexual problems following breast cancer treatment, and difficulties with intimacy and sexuality tend to extend past the 1 year post-treatment point. Given that resources available for couples who experience sexual distress after breast cancer are virtually non-existent, there is a need to develop and empirically evaluate psychosexual interventions for breast cancer patients and their partners.

The purpose of this study is to evaluate the feasibility, process, and outcomes of an online, couples-based intervention designed to address sexual problems encountered by many couples facing breast cancer. The intervention will take place in the form of six E-therapy sessions delivered via secure, encrypted videoconferencing software commonly used by health care providers practicing telemedicine. Each session will be supplemented by psychoeducational materials (i.e. reading and/or video) available through a privately accessed homepage for the study.

Thirty couples will participate in the study, and will be be randomized to either the treatment condition or the wait-list control condition. Participants assigned to the wait-list will have the option of receiving the online program once they have completed their commitment to the study (approximately 5 months later). In addition to completing standardized questionnaires, couples will participate in pre- and post-treatment interviews, which will be analyzed thematically in order to improve the intervention and its delivery.

The proposed project builds upon existing research pertaining to the sexual health implications of female cancer survivorship, and will fill a gap both in the literature and support available to breast cancer survivors experiencing sexual distress. Given that sexual distress is such a crucial concern for women with breast cancer, and that the majority of couples experiencing sexual difficulties may not receive adequate support in this regard, the goal of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help improve the quality of life of couples affected by breast cancer.

An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer

An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial

The Program Expectancy Questionnaire will assess participants' expectations for the intervention, including the degree to which they believe the intervention will be effective.

The SFQ assesses couples' sexual satisfaction and functioning. The SFQ will be used to assess change in couples' level of sexual functioning.

The RDAS assesses couple's level of relationship satisfaction.

The Maudsley Marital Questionnaire assesses martial quality and happiness.

The POMS-SF assesses overall psychological adjustment.

This measure assesses psychological adjustment, specifically with respect to depressive symptoms.

This measure assesses psychological adjustment, specifically with respect to anxiety

The BCPT measures commonly reported physical and psychological symptoms associated with breast cancer and associated treatments.

The SSC measures partners' perceived support of their female partners

Canadian Breast Cancer Foundation

Sunnybrook Health Sciences Centre

Principal Investigator

Head and Neck Neoplasms

Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.

The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention.

Couple-Based CBT Intervention

Tina Gremore, PhD

The purpose of this study is to determine whether a brief couple-based supportive intervention effectively assists patients and their partners coping with the challenges of head and neck cancer.

This intervention will adapt a well-validated cognitive-behavioral therapeutic approach in a four-session intervention to teach patients and partners specific couple-based cancer-focused support skills. In addition, in order to gather information on outcome variables, couples will complete three assessments during the course of treatment (pre-treatment, following treatment, and six month follow-up). These assessments will include questionnaire measures as well as couple communication whereby couples will participate in two videotaped conversations whereby one partner of the couple discusses a concern and the other member of the couple provides support. We also will implement a "daily diary" assessment whereby day-to-day psychological and physical symptoms experienced by the patient and partner will be assessed and daily effects of the intervention can be analyzed. Patients and partners will participate in the daily diary portion of the study following the post-assessment. They will be emailed an electronic link to a brief questionnaire daily for 7 days. The items in this daily assessment will comprise questions that are part of the general assessment measures such as dyadic coping, spousal support, and relationship satisfaction. The patient will also complete questions about pain and fatigue.

Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners

NorthShore University HealthSystem

Asst Director, Research Compliance

CST provides education about acute and long-term side-effects of HNC and teaches: 1) self-management skills to control/prevent side-effects; 2) communication skills to facilitate coordination of care; and, 3) strategies to improve communal coping and confidence in the ability to work as a team.

Patients receive standard symptom management education by their health care team.

Patients and partners each receive a workbook and 6 one-hour telephone sessions with a Masters level trained interventionist. Manual content is tailored based on role (patient or partner). Couples participate together via speaker phone for half the sessions and patients and partners receive separate (individual) intervention calls for the other half of the sessions.

Couples Skill-Training (CST)

Hoda Badr, PhD

By teaching skills to improve the coordination of care and support in couples coping with head and neck cancer (HNC), this couple-based psychosocial intervention holds great promise for improving self-management, reducing costly hospitalizations and treatment interruptions, and improving both partners' quality of life. Home-based delivery will enhance future dissemination and outreach to those who do not have access to psychosocial services or live far away from their care centers. If found effective, the intervention may also have salutary downstream effects on the health and well-being of HNC patients and their partners.

Patients treated with radiation (XRT) for head and neck cancers (HNCs) experience significant side effects such as abnormally reduced salivation, difficulty swallowing, and taste changes even after they have been definitively treated. To control side effects and minimize discomfort, intensive self-care protocols are prescribed, but adherence is poor. Partners (spouses/significant others) can play a critical role in supporting adherence, but often lack knowledge, experience high rates of distress, and display poor communication (e.g., critical or controlling), that can interfere with patient self-care. The investigators have developed a home-based couples skills-training (CST) intervention that teaches: 1) self-management skills to control/prevent side-effects; 2) communication skills to facilitate coordination of care and support; and 3) strategies to improve communal coping and confidence in the ability to work as a team. The goal is to reduce healthcare utilization and improve multiple domains of patient and partner QOL. Specific aims are to: develop and evaluate the content and materials of the CST intervention (AIM 1) and evaluate its feasibility and acceptability (AIM 2). The multidisciplinary team will review and evaluate the content we have already developed based on the ongoing work with HNC couples (K07). Once content is finalized, tailored manuals will be developed for patients and partners and evaluated through two focus groups (AIM 1). The investigators expect that most couples (\> 60%) approached will agree to participate and that CST will be well-accepted (AIM 2). Knowledge gained will be used to refine CST and to collect data on effect sizes and variation for a larger trial. Innovation: CST takes a multiple-behavioral approach to addressing and preventing HNC treatment side effects and, in the process, seeks to improve multiple domains of QOL. It is also the first program in HNC that actively involves both members of the couple to address barriers in the home environment in which self-management occurs. Finally, this study conceptualizes the couple relationship as a resource and leverages that resource to improve patient care and outcomes. Impact: Home-based delivery will enhance future dissemination and outreach to the target population. Overall, CST holds great promise for improving patient self-management behaviors, reducing costly hospitalizations and treatment interruptions, and improving multiple aspects of patient and partner QOL.

Improving Self-Management in Head and Neck Cancer

satisfaction with the intervention by completing a program evaluation questionnaire developed by the study team that asks about perceived skills mastery and satisfaction with program content and logistics

measures distress with Patient Reported Outcomes Measurement Information System (PROMIS) short form for anxiety and depression

number of hospitalizations and unplanned clinic visits

National Cancer Institute (NCI)

Baylor College of Medicine

Associate Professor

Cancer-Related Community and Internet Resources

Couples meet individually with a health educator for 6 sessions to learn about ways to support each other and communicate about breast cancer related issues.

Cancer-Focused Relationship Enhancement

Couples meet individually with a health educator for 6 sessions to discuss the medical aspects of breast cancer and treatment options.

Couple's Cancer Education

Donald H Baucom, Ph.D.

Laura S Porter, Ph.D.

The purpose of the proposed study is to evaluate the efficacy of a new couple-based intervention for women with recently diagnosed, early stage breast cancer and their spouses or male partners. This cancer-focused relationship enhancement intervention adapts well-validated cognitive-behavioral interventions to teach patients and partners specific relationship skills, such as problem-solving skills, communication, and maximizing positive interactions, that they can use in addressing breast cancer. This project's major goals are to improve the patient's individual functioning and specific aspects of the couple's relationship affected by breast cancer (e.g., mood, role functioning, sexual functioning, and social support). In the current investigation, cancer-focused relationship enhancement will be compared to (a) a couple-based Cancer Education intervention and (b) a Treatment-as-Usual condition.

A Couples Approach to Enhance Breast Cancer Survivorship

Duke University

University of North Carolina, Chapel Hill

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Couples will receive four 60-minute intervention sessions via videoconference with Duke staff. Study staff will provide couples with instructions for use of the iPad computer and videoconference software which will be used to deliver the intervention sessions.The first 3 sessions will be conducted weekly, with a booster session occurring approximately one month later.

Couples will have the option to receive the intervention after they complete the follow-up survey. This version of the intervention will not include the booster session, so will last approximately 1 month in total. If they choose to receive the intervention, they will be provided with a tablet computer if they do not have one.

To develop and test a couple-based physical activity intervention among cancer survivors and their partners

Physical Activity Intervention

Laura Porter, PhD

This pilot study will develop and test a couple-based physical activity intervention among cancer survivors and their partners.

Aim 1: To determine the feasibility and acceptability of a couple-based physical activity intervention for cancer survivors. Feasibility will be quantified using rates of study eligibility, overall accrual, attrition, and adherence to the study protocol. Acceptability will be assessed via couples' ratings on a standardized measure of treatment effectiveness/ satisfaction, supplemented open-ended questions

Aim 2: To provide preliminary data on the effects of a couple-based physical activity intervention relative to a wait list control group on survivor outcomes (i.e., level of physical activity, quality of life, self-efficacy for achieving and maintaining physical activity goals, perceived partner support for physical activity, and quality of the survivor-partner relationship). The investigators hypothesize that the intervention will produce benefits in each of these domains.

Aim 3: To provide preliminary data on the effects of a couple-based physical activity intervention relative to a wait list control group on partner outcomes (i.e., partner's level of physical activity, self-efficacy for helping the survivor achieve and maintain physical activity goals, and quality of the survivor-partner relationship). The investigators hypothesize that the couple-based intervention will produce benefits in each of these domains.

Background and Significance:

Physical activity (PA) is an essential part of cancer survivors' treatment plan as it helps prevent recurrence and improves cardiovascular fitness and downstream cardiovascular risk, the cause for most deaths in cancer survivors. Additional benefits of increasing PA include improvements in body composition, physical function, psychological outcomes, and quality of life. However, most survivors are not sufficiently active and would benefit from an intervention to promote PA. Prior PA interventions for cancer survivors have had mixed success. A recent systematic review identified 14 RCTs testing exercise interventions among sedentary cancer survivors and concluded that there was insufficient evidence that existing interventions are successful in achieving recommended levels of PA. In particular, there has been a lack of attention to psychosocial aspects of changing behavior, and to strategies that promote independent exercise behavior that can be maintained over time. Thus, it is clear that novel approaches to PA interventions are needed.

Design:

This is a two-arm randomized controlled trial to evaluate a couple-based physical activity (PA) intervention that systematically trains partners in skills to support the survivor in PA initiation and maintenance strategies.

Couples randomized to Arm 1 (the Couples-Based Physical Activity Intervention) will receive four 60-minute intervention sessions via videoconference with Duke staff. Study staff will provide couples with instructions for use of the iPad computer (if provided by the study) and videoconference software which will be used to deliver the intervention sessions. Couples will also be provided with contact information for technical support. The first 3 sessions will be conducted weekly, with a booster session occurring approximately one month later. The intervention will include components to (a) encourage couples' favorable outcome expectations about the benefits of working together to initiate and maintain increases in PA, (b) build their confidence that they can work together to accomplish their goals, and (c) help them identify and use communal strategies, such as couple communication and joint decision making about goals and plans for increasing physical activity, and working through barriers to making these changes. Finally, the intervention will incorporate important behavior change techniques that have been found to help people change their exercise behavior, such as goal setting, self-monitoring of behavior, and prompts for practice, adapting them to a communal coping approach. Treatment sessions will be audio recorded for QA purposes.

Those randomized to Arm 2 (waitlist control) will have the option to receive the intervention after they complete the follow-up survey. This version of the intervention will not include the booster session, so will last approximately 1 month in total. If they choose to receive the intervention, they will be provided with a tablet computer if they do not have one.

Move 2 Health: A Couple-Based Physical Activity Intervention for Cancer Survivors

A Couple-Based Physical Activity Intervention for Cancer Survivors

We will not share IPD unless requested by Duke Researchers only.

Behaviors and Mental Disorders

Caregiver Burden

Stress, Psychological

Behavioral Symptoms

Young adults with cancer and their partner-caregivers will attend dyadic virtual psychotherapy sessions lasting 45-60 minutes on a weekly basis for eight weeks.

This intervention is based on cognitive-behavioral therapy and couples' therapy. It aims to improve cancer and caregiving-related self-efficacy and coping, as well as promote relationship maintenance in context of cancer. The intervention will be delivered by a trained mental health practitioner and include didactics, experiential exercises, and home practice.

Young Adults Coping with Cancer Together Intervention

Jamie M Jacobs, Ph.D.

Zeba N Ahmad, Ph.D.

Jamie M Jacobs, PhD

Giselle K Perez, Ph.D.

The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.

Young adults (YA) with cancer have unique challenges in coping, and their primary partners may experience burden and low self-efficacy related to caregiving. In this single-arm pilot trial, the investigators shall deliver an eight-session intervention to YAs with cancer and their self-identified partners who provide caregiving. The intervention is founded on principles from cognitive-behavioral therapy and couples-focused interventions, tailored for YA. The aim of the study is to assess the feasibility and acceptability of the intervention, which will inform refinements prior to a larger-scale clinical trial. This study will include 10 YAs and their partner-caregivers (N=20). Participants will complete surveys at baseline and after the intervention, and will be invited to complete optional semi-structured exit interviews.

A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: jjacobs@mgh.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Feasibility will be measured by measured by participant rates of enrollment (≥50% of those eligible), participant retention (≥70% of those enrolled), and intervention attendance (≥70% attending at least 6 of 8 sessions).

Acceptability with be measured by satisfaction with the intervention as rated on the Client Satisfaction Questionnaire. The intervention will be deemed acceptable if ≥75% of participants report average satisfaction that exceeds the CSQ's midpoint.

Massachusetts General Hospital

Assistant Professor, Harvard Medical School Department of Psychiatry

Patients and partners in the partner-assisted emotional disclosure condition will attend four weekly face-to-face sessions with a therapist. The first session will last 75 minutes and will focus on training in skills to facilitate the patient's disclosure. The subsequent 3 sessions will last 45 minutes each. In these sessions, the therapist will briefly review the strategies and provide feedback from the previous session and the patient will spend 30 minutes talking about their cancer-related concerns to the partner.

Partner-assisted emotional disclosure

The cancer education protocol consists of four weekly face-to-face sessions for education about living with GI cancer. The cancer education sessions will be delivered to patients and their partners and use a presentation and discussion format. Handouts and discussion sessions will center on the following topics: Orientation to Duke Cancer Care and the treatment team; suggestions for communicating with health care providers; resources for health information, psychosocial support, and financial concerns; evaluating health information on the internet; the impact of cancer on different domains of quality of life; and suggestions for maintaining quality of life.

Cancer Education

Laura Porter, Ph.D.

The long-range goal of this research is to develop better ways of helping GI cancer patients and their caregivers cope more effectively with the demands of the disease. The study is designed to test the hypothesis that a partner-assisted emotional disclosure intervention will be more effective in enhancing patient' psychological adjustment than a cancer education condition.

The diagnosis and treatment of GI cancer is a traumatic and life-altering event. Many patients with GI cancer experience significant emotional distress and disruptions in their social relationships as well as multiple physical symptoms and limitations in physical activities. There is evidence that cancer patients who are able to confide their feelings and concerns about the cancer experience with supportive others, particularly their partners, fare better. patients who are able to discuss cancer openly with their partners report fewer emotional and physical complaints, and higher levels of self-esteem and perceived control. However, there are a number of barriers that often inhibit discussion of cancer-related feelings. The proposed study will examine the effect of a new partner-assisted emotional disclosure (ED) protocol for patients with GI cancer.

In this study, 200 patients diagnosed with GI cancer and their partners will be recruited to participate. The couples will be randomly assigned to one of two conditions: 1) partner-assisted emotional disclosure, or 2) cancer education. Assessment measures will be collected at evaluations conducted before and after treatment and at 8 weeks post treatment. All evaluations will be conducted over the phone. Information will also be collected from the physician and/or the patient's medical record at each of the three evaluations. Audiotapes of the partner-assisted emotional disclosure sessions will be transcribed and 10-minute segments will be randomly selected and analyzed to assess the extent to which patients express emotions and partners verbally reflect the partner's feeling in an empathic manner.

Partner-Assisted Emotional Disclosure for GI Cancer

Partner Assisted Emotional Disclosure for GI Cancer

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

Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.

Psychological intervention

Dorte G Hansen, PhD

Mariët Hagedoorn, Professor

Christoffer Johansen, Professor

Henrik Flyger, MD, Ph. D

This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care

The intervention intends to improving the patient and partners well-being, quality of life and their relationship adjustment.

The couples in the intervention group participates i six to eight couple sessions. The sessions is conducted by an experienced psychologist and takes place one to five months after the patients cancer diagnosis. The control group receives usual care.

The framework of the intervention is attachment theory and the psychologists support and advise the couples in talking candidly about their feelings regarding their new life situation with cancer. The psychologist focus on the couples ability to feel comfortable and safe in each others presence.

Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners

Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.

IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners

Assesses feelings of anxiety and depressive symptoms. Assessed by both patients and partners.

Assesses mood changes. Assessed by both patients and partners

Assesses relationship functioning and marital satisfaction. Assesed by both patients and partners

RQ provides a profile of an individual's attachment feelings and behaviour. Assessed by both patients and partners

Assesses health-related quality of life with additional questions for women dignosed with breast cancer.

Assesses health-related quality of life. Assessed by partners

Assesses individual fellings of fatigue. Assessed by the patients

Assesses positive changes in individuals experiencing traumatic life events. Assessed by both patients and partners

Assesses health-related quality of life. Assessed by both patients and partners

Odense University Hospital

Ringsted Hospital

University of Copenhagen

Region of Southern Denmark

Danish Cancer Society

University of Southern Denmark

MPH, Ph.D. student

Digestive System Diseases

Rare Diseases

Rumination Syndrome

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Rumination Disorder

MBSR (mindfulness-based stress reduction) is a group-based, 8-week program that was developed at the University of Massachusetts Stress Reduction Clinic under the direction of Jon Kabat-Zinn. MBSR is comprised of a structured, developmentally sequenced curriculum that uses a group format to experientially instruct participants in the practice of mindfulness meditation and mindful Hatha yoga. Each session includes different forms of meditation practice, such as cultivating awareness of thoughts, feelings and bodily sensations, and learning to incorporate this awareness during stressful emotional and/or physical life situations. Lesson activities include the following: (1) mindful meditation (e.g., awareness of breathing, body scan, sitting, walking); (2) yoga; and (3) group discussion.

HealthPro is a health promotion program designed by Dr. David Victorson of Northwestern University Medical Social Sciences Department and his research team to function as a matched control for the MBSR intervention in this research study. The program teaches and promotes healthy behaviors, skills, and lifestyles. Major learning themes include: (1) health behavioral change readiness and self-assessment; (2) physical activity, movement, and non-sedentary lifestyles; (3) dietary and nutritional considerations for optimal health; (4) emotional wellness and coping with difficulties; (5) social engagement, relationships intimacy, and health; (6) managing bodily pain; (7) weight management and weight loss strategies; (8) health behavior maintenance over the long-term.

Health promotion

David E Victorson, Ph.D.

We propose to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a sample of men on AS and their spouses.

The current study proposes to examine the efficacy of couples-based mindfulness-based stress reduction (MBSR) on positive and negative psychological responses to active surveillance (AS) and AS adherence, with a larger, more geographically representative sample of men on AS and their spouses. We will compare the MBSR intervention condition (Group A) with a health promotion and wellness condition (Group B) in a sample of prostate cancer patients and their spouses. We will evaluate its efficacy on self-reported measures of positive and negative psychological responses to AS.

PRIMARY AIM Examine longitudinal change in positive and negative psychological responses to AS between groups over time.

SECONDARY AIM Observe the relation between positive and negative psychological responses to AS and AS adherence between groups over time.

THIRD AIM Explore dyadic factors on positive and negative psychological responses to AS and AS adherence between groups over time.

Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education

longitudinal change in psychological responses as assessed through online survey

relation between psychological responses to AS as assessed by online survey

dyadic factors on psychological responses as assessed by online survey

Fox Chase Cancer Center

University of Michigan

Northwestern University

Symptoms and General Pathology

Body Weight

Participants will receive 12 session (6 weekly and 6 biweekly) of a behavioral weight and symptom management intervention.

Investigators anticipate that the intervention developed in phase I will consist of a total of 12 sessions 90 minutes in length (18 therapy hours) spaced across approximately 5 months. Sessions are spaced to provide participants sufficient time to complete home practice exercises and adequately examine change in weight and maintenance of weight loss. Sessions will be conducted individually for each day. The first 6 sessions will occur weekly and the final 6 sessions will occur biweekly.

Couples-Based Behavioral Weight and Symptom Management

Caroline S Dorfman, PhD

The objective of the study is to develop and test the feasibility, acceptability, and initial efficacy of a novel couples-based behavioral weight and symptom management intervention for obese breast cancer survivors and their partners. The proposed project consists of two phases. Phase I will include intervention development and refinement. Intervention development will be guided by the research team's prior work, the interdependence model of communal coping and behavior change, and information obtained from couples participating in focus groups. The intervention protocol will then be tested with 5 couples to assist with refinement of intervention content. During phase II, the feasibility, acceptability and initial efficacy of the intervention will be examined. Obese breast cancer survivors in the three years following treatment and their overweight or obese partners will receive 6 weekly and 6 biweekly sessions for a total of 12 sessions spaced across approximately 5 months. The intervention will be provided in a couples-based format where each couple will meet separately with the therapist. Couples will be assessed at pre-, post-, and 3-months post-treatment. Study outcomes will be weight, symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity. Exploratory outcomes examine biomarkers (i.e., insulin, IL-6, IL-8, TNF-alpha, adiponectin) associated with health outcomes for cancer survivors and their partners. It is hypothesized that the intervention will be feasible (i.e., completed sessions), and participants will find the intervention acceptable as assessed by a measure of treatment acceptability. It is also hypothesized that participants will evidence decreased weight and improvements in symptoms (i.e., pain, fatigue, distress), eating behavior, and physical activity, and their change in weight will covary with change in symptoms, eating behavior, and daily physical activity. Finally, it is hypothesized that participants with greater weight loss will evidence improved functioning in insulin, IL-6, IL-8, TNF-α, adiponectin, and heart rate.

Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners

Participants will be weighed at each assessment and each session.

Participants will wear wireless activity trackers (Fitbits) to measure daily activity (e.g., steps taken). Participants will be provided with the activity trackers by study staff and begin to use the trackers following the pre-treatment assessment. Participants will continue to use the trackers throughout treatment. Participants will return the Fitbits to the study staff upon completion of the study.

The 6-minute walk test is a self-paced, timed test of the total distance in meters that a patient is able to walk over a six-minute period and assesses the ability to exert effort during activity.

The degree of pain experienced during the 6-minute walk test will also be assessed.

The L-Cat is a measure of physical activity. Individuals identify which descriptive category best describes their level of activity during leisure time in the last month. Descriptive categories range from inactive to very active.

Participants will also be asked to complete the Dietary Instrument for Nutrition Education (DINE). The DINE is a brief assessment of the amount of fat and dietary fiber in an individual's usual diet. Participants are provided with a list of food items and asked about the frequency with which they have eaten the items per week when considering the last month.

The BPI is a 9-item self-report measure assessing pain severity. Participants rate their pain on a scale from 0 to 10 where 0 represents "no pain" and 10 represents "pain as bad as you can imagine." Participants also rate their level of interference from pain.

The Promis Fatigue Scale is a 6-item self-report measure of fatigue in the last week

The POMS will be used to assess psychological distress. Each item is rated on a scale from 0 (not at all) to 4 (extremely) as being self-descriptive for the last seven days.

Participants will also complete the International Physical Activity Questionnaire (IPAQ). This seven-item questionnaire assesses the amount of time participants have spent doing moderate and vigorous physical activities in the last seven days.

Eating behaviors will be assessed using the Three Factor Eating Questionnaire (TFEQ). The 21-item short-form will be used for the present study. The TFEQ measures three domains of eating behavior: 1) cognitive restraint, 2) uncontrolled eating, and 3) emotional eating.

Fasting insulin will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.

The pro-inflammatory cytokine IL-6 will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.

The pro-inflammatory cytokine IL-8 will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.

The pro-inflammatory cytokine TNF-alpha will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.

The anti-inflammatory cytokine adiponectin will be examined by taking a sample of peripheral blood from participants at the baseline and post-treatment assessments.

Heart rate will be assessed via the wireless activity trackers (Fitbit) worn by participants throughout the study.

The Treatment Acceptability Questionnaire (TAQ) is a six-item scale assessing whether participants view an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable).

Treatment feasibility will be assessed by measuring the session attendance rate for each participant and each day.

Participants' use of intervention strategies will be assessed using a measure developed for components of the present study. Participants will be asked about how frequently treatment strategies discussed in session have been used outside of session in the past week or past month depending on the timing of the questionnaire. A scale ranging from 0 "not at all" to 5 "2 or more times a day" will be used.

Partner support for eating and exercise will be assessed using a modified version of the Social Support for Diet and Exercise questionnaires. Participants will be asked to provide information about the amount of encouragement and discouragement they have received from their partner over the last three months regarding healthy eating and exercise. Items are rated on a 5 point scale from 1 "none" to 5 "very often."

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer	NCT01881022	Breast Cancer	Psychosexual In...	- 80 Years	Sunnybrook Health Sciences Centre
Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners	NCT01785576	Head and Neck C...	Couple-Based CB...	18 Years -	NorthShore University HealthSystem
An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer	NCT01881022	Breast Cancer	Psychosexual In...	- 80 Years	Sunnybrook Health Sciences Centre
Improving Self-Management in Head and Neck Cancer	NCT02409485	Head and Neck C...	Couples Skill-T...	18 Years -	Baylor College of Medicine
A Couples Approach to Enhance Breast Cancer Survivorship	NCT00665899	Early-Stage Bre...	Cancer-Focused ... Couple's Cancer...	-	University of North Carolina, Chapel Hill
Move 2 Health: A Couple-Based Physical Activity Intervention for Cancer Survivors	NCT03266718	Physical Activi... Cancer Survivor	Physical Activi...	18 Years -	Duke University
A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers	NCT06172907	Cancer Survivorship Caregiver Burde... Psychological D... Coping Skills Couples	Young Adults Co...	25 Years - 39 Years	Massachusetts General Hospital
Partner-Assisted Emotional Disclosure for GI Cancer	NCT00734513	Cancer of the G...	Partner-assiste... Cancer Educatio...	18 Years -	Duke 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
Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners	NCT01368380	Breast Cancer	Psychological i...	18 Years -	University of Southern Denmark
Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination Thru Engagement in Mindfulness Education	NCT02871752	Prostate Cancer	Health promotio...	18 Years -	Northwestern University
Behavioral Weight and Symptom Management for Breast Cancer Survivors and Partners	NCT02574507	Breast Cancer	Couples-Based B...	21 Years - 80 Years	Duke University
Partner-Assisted Emotional Disclosure for GI Cancer	NCT00734513	Cancer of the G...	Partner-assiste... Cancer Educatio...	18 Years -	Duke University

Spots Global Cancer Trial Database for couples

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

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