Clinical Research Directory

Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan

Breast cancer is the most common cancer among women worldwide, and many survivors experience comorbid mental health conditions such as depression and anxiety, which can significantly worsen health outcomes and increase mortality. This large-scale trial in Pakistan aims to evaluate the clinical and cost-effectiveness of a three-stage adaptive intervention to manage depression among breast cancer survivors. Using a Sequential, Multiple Assignment, Randomised Trial (SMART) design, the study will recruit 26,372 participants aged 18 and above who have completed initial breast cancer treatment (surgery and/or chemotherapy or radiotherapy). Participants will be identified through primary care units, outpatient departments, oncology clinics in public hospitals, and charitable organisations across Pakistan. Depression will be screened using the Patient Health Questionnaire PHQ-9, with diagnosis confirmed by the Structured Clinical Interview Schedule of DSM (SCID). Those randomised to the intervention arm will receive adaptive interventions: starting with low-intensity guided self-help, followed by a high-intensity cognitive behavioural therapy-based programme called "Moving On After Breast Cancer Plus" (Moving on ABC Plus), and for non-responders, an additional pharmacological component will be introduced. Participants in both adaptive intervention and enhance usual care groups will be assessed at multiple time points-baseline, 6, 18, 30, and 48 weeks post-randomisation-using validated tools to measure depression (primary outcome), and anxiety, self-esteem, intrusive thoughts, health-related quality of life, satisfaction with services, and health resource use (secondary outcomes). The study will also include qualitative interviews and focus groups discussions with patients, caregivers, healthcare providers, and policymakers to identify barriers and facilitators to implementation and ensure the intervention is both contextually appropriate and scalable.

Testing the Feasibility of a Virtual Application to Support Breast and Colorectal Cancer Survivors

The goal of this study is to determine the feasibility of implementing a mobile health application for breast and colorectal cancer survivors following primary treatment. Developed in collaboration with Seamless MD, the intervention acts as an information hub, providing users with timely and evidence-based information related to follow-up care as well as health system/community-based resources and programs to meet their needs during this period of care. The goal of the intervention is to encourage open communication regarding survivorship expectations and provide survivors with appropriate information and support to meet their needs. This study will: 1. Test the feasibility of implementing the virtual intervention at two cancer centres in Atlantic Canada (Nova Scotia and New Brunswick) 2. Gather feedback regarding the intervention from cancer survivors and healthcare providers. Participants will have access to the intervention for a period of six months. Questionnaires will be distributed to participants through the intervention at baseline, 90 days, and 180 days to assess user experience. Semi-structured interviews will be conducted with select survivor participants and healthcare providers (oncology and primary care) to determine the feasibility and acceptability of this intervention.

Group Interventions for Breast Cancer Survivors

The purpose of this study is to compare two types of groups for breast cancer survivors: a Meaning-Centered Group and a Discussion Group. Many breast cancer survivors seek help to deal with the emotional burden of having gone through the cancer experience. Participation in groups offering support often helps cancer survivors cope with stressors of life after having had cancer by giving them a place to express their feelings. The "Meaning-Centered Group" is intended to teach breast cancer survivors how to maintain or even increase a sense of meaning and purpose in their lives after treatment for cancer. The "Discussion Group" is intended to help breast cancer survivors cope by giving them a place to get support from other breast cancer survivors. The goal of this study is to compare the benefits of these two types of group approaches for breast cancer survivors. The study is also testing the benefits and feasibility of conducting the groups virtually using a telephone and computer.

Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors

The researchers are doing this study to compare two different types of group therapy and find out whether they are effective approaches for helping breast cancer survivors manage joint pain caused by aromatase inhibitors (AI). This type of joint pain is called AI-associated arthralgia, or AIA, and it is common in people taking AIs. AIA and its associated symptoms can make some people decide to stop taking their medication. The study will look at the effects of two different types of group therapy on participants' cancer-related symptoms (such as pain, fatigue, and anxiety), their ability to continue taking AIs on a regular schedule, and their quality of life. We will measure participants' quality of life by having them fill out questionnaires. Both groups will have 2-hour group therapy sessions once a week, over the course of 8 weeks. During the sessions, you will be in a group of 6-10 participants, who may be a mixture of patients from both MSK and University of California San Diego (UCSD).

Quality of Life in Breast Cancer Survivors Who Were Pregnant During Their Cancer Treatment

To assess the quality of life for women who were pregnant during their breast cancer treatment.

tDCS Intervention in Breast Cancer Survivors With and Without Obesity Reporting Cognitive Impairment

The goal of this intervention is to investigate whether transcranial Direct Current Stimulation (tDCS) can alleviate Cancer-Related Cognitive Impairment (CRCI) in breast cancer survivors, as measured by changes in brain structures and cognitive performance. To assess the efficacy of tDCS, the investigators will compare outcomes between participants receiving active stimulation and those receiving sham stimulation (a placebo condition where participants believe they are receiving stimulation, but are not). Participants will: * Undergo a baseline MRI session * Receive either active or sham tDCS for six weeks * Undergo a follow-up MRI session * Complete cognitive tests and respond to psychosocial questionnaires before, during, and after the tDCS intervention

A Targeted Electronic Health Approach to Reduce Fear of Recurrence in Breast Cancer Survivors (FoRtitude)

The goal of this study is to determine if the intervention or if general information about being a breast cancer survivor can help Breast Cancer Survivors reduce their fear of recurrence. The main question it aims to answer are: Can the FoRtitude intervention lower the fear of recurrence for Breast Cancer Survivors? Participants will: Answer questions about their fear of recurrence. Be randomized to 1 of the 3 following options: (1) a weblink to access an eHealth intervention which includes a website and an optional interactive text-messaging feature, (2) a weblink to a non-interactive website that will include links to external websites with general information that may be helpful for Breast Cancer Survivors, or (3) you will need to talk with your oncology team about your concerns about recurrence or seek psychosocial care in the community. Be asked to fill out questionnaires 5 times for up to 18 months.

Transcranial Direct Current Stimulation for Cancer-related Cognitive Impairment in Breast Cancer Survivors

This study aims to evaluate the efficacy of transcranial direct current stimulation (tDCS) in improving cancer-related cognitive impairment (CRCI) in breast cancer survivors. Participants will be randomly assigned to receive active or sham stimulation over the prefrontal cortex. Cognitive outcomes will be assessed using standardized neuropsychological tests and self-reported measures. Functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) will be used to explore neural correlates of intervention effects.

The Use of Combined Motor Imagery and Action Observation to Evaluate the Influence on Functional Parameters Such as Strength, Range of Motion, Pain or Fear of Movement Among Others, in Females Breast Cancer Survivors.

The aim of this study is to evaluate the effectivity of the combined motor imagery and action observation therapies to improve functional parameters such as strenght, range of motion, pain or fear of movements among others in relation to upper limb in breast cancer survivors. The main question it aims to answer is: Will a combined therapy of motor imagery and action observation improve the strenght, rang of motion, pain, limb diameter and fear of movement of the upper limb in breast cancer survivor females? The participants will be part of the IM-OA23 proyect that consist on seeing some diferent videos about upper limb mobility and then they'll have to imagine the movements and to performed themselves. Researches will compare two groups (control group and intervention group) to evaluate the diferences between them.

Acupuncture for Anxiety and Depression

The study aims to primarily investigate the effects and safety of acupuncture on anxiety and depression among patients with breast cancer.

Compassion, Social Support, Flexibility, and Resilience Program for Women Surviving Breast Cancer

The goal of this clinical trial is to investigate the effects of an Acceptance and Commitment Therapy (ACT) based program (ReACT) to increase social support, compassion and psychological flexibility on psychological resilience in women undergoing mastectomy. The main question it aims to answer is: Does the ReACT program improve participants' resilience by increasing social support, compassion, and psychological flexibility? Researchers will compare intervention group to control group to see if ReACT program works to improve participants' resilience. Researchers will randomly divide participants into two groups: intervention group and control group. * Participants will complete some questionnaires. * Participants in the intervention group will join a 3-week ACT-based psychological flexibility program. This program consists of sessions that last 90 minutes each. The program adopts the core principles of ACT and aims to help participants develop skills in mindfulness, acceptance, value-driven living, and cognitive defusion. * Participants will complete the same questionnaires again after the program. * Participants will complete the same questionnaires again 1 month after the program ends.

Effects of Two Strength Exercise Programs on Upper Limb Functionality in Breast Cancer

The goal of this experimental study is to evaluate the effect of a therapeutic exercise program based on upper limb plyometric exercises in breast cancer patients and breast cancer survivors to determine changes in upper limb functionality. The main question it aims to answer is: Does upper limb plyometric strength exercise improve upper limb dysfunctions in breast cancer patients and survivors? The researchers will compare the effects of plyometric exercise with the effects of strength training exercise to determine whether plyometric exercise improves shoulder dysfunctions in breast cancer patients and survivors. Participants from the Pontevedra group will undergo the intervention using plyometric exercise (Experimental Group), while those from the Vigo group will perform strength training exercise (Control Group). They will complete two sessions per week for six weeks. Outcome variables related to upper limb functionality will be assessed at baseline and after the intervention.

The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors

The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.

Collaborative Research: Multiscale Modeling and Intervention for Improving Long-Term Medication

The goal of this study is to learn about the impact of an integrated medication monitoring system in breast cancer survivors aged 21-70 who are prescribed endocrine therapy. The main question it aims to address is: Does the integrated medication monitoring system improve medication adherence among breast cancer survivors when used over a six-month period? Fifteen English-speaking breast cancer survivors who meet the inclusion criteria will use a combination of smartphone-based ecological momentary assessments, a medication event monitoring system (Wisepill), and a wearable sensor (Fitbit). After 2 months, participants will be provided personalized content to facilitate medication adherence through an app (Digital Trails) and through WisePill. Participants will complete online surveys at baseline, 3 months, and 6 months to assess their experiences and adherence.

A Mindfulness-Based Self-Compassion Program

The purpose of this study is a pre-test-post-test, randomized controlled experimental study with a control group, planned to examine the effect of the mindfulness-based self-compassion program applied on women with breast cancer on spiritual well-being and self-compassion levels.

Self-Determination Theory-informed Occupational Therapy Program to Increase Physical Activity Among Survivors of Breast Cancer

We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote engagement in aerobic physical activity (PA) and muscle strengthening exercise (MSE). The telehealth-based delivery of this OT program circumvents some barriers to OT access and participation (e.g., time burden; distance to OT clinic) among breast cancer survivors- particularly important for Oklahoma given that 33% of residents live in rural areas. Additionally, the focus of this program is to promote the preferred aerobic PA and MSE choices of each individual survivor to increase the likelihood of long-term PA engagement. In turn, participants will be more likely to experience the longer-term benefits associated with PA such as improved physical functioning, reduced anxiety, depressive, and pain symptoms, better sleep, and better cardiorespiratory fitness.