Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Frailty

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

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

Ovarian Cancer

Ovarian Epithelial Cancer

Circuit-based prehabilitation exercise intervention

The exercise intervention will consist of light-to-moderate intensity aerobic, resistance, and mobility exercises. These exercises will be performed in a circuit type manner. Participants will perform similar exercises that are modified to meet their individual abilities. Exercise intensity, modifications and substitutions will be determined for each participant based on their medical history, 6 minute walk test results, and baseline frailty scores. Exercise sessions will be performed 3x/wk beginning at 30 min and progressing to 60-min as tolerated for a minimum of four weeks but will continue up until the time of the participants surgery. A hybrid approach will be used for the exercise sessions whereby the participant must attend the first exercise session in person and subsequent sessions will be delivered virtually. Sessions will be overseen by the study Clinical Exercise Physiologist.

Prehabilitation Exercise Intervention

Scott Grandy, PhD

Scott Grandy, MD

Individuals with ovarian cancer have very poor survival rates. This is because the cancer is not usually detected until it has reached advanced stages. How long an individual survives also is determined by the cancer treatment they receive. Although there are best treatment practices to improve survival, some women have other conditions that limit treatment options. One such condition seen in as many as 50% of women with advanced ovarian cancer is frailty (an age-related decline in function and health). This is a major concern as doctors will often have to change how the cancer is treated based on the patient being frail. For example, patients living with frailty are less likely to have their full tumor removed during surgery. They are also more likely to have complications with surgery, stay in the hospital longer, and recover less well from surgery overall. Patients living with frailty also are more likely to experience delays in their chemotherapy starting, receive lower doses of chemotherapy and/or receive fewer cycles of chemotherapy. These changes in treatment may decrease how long a patient survives after diagnosis. Thus, research is needed to explore strategies to decrease frailty in patients who require treatment for advanced ovarian cancer. An option gaining more attention is physical exercise (e.g. walking, repeatedly rising from a chair). Exercise performed before surgery, which is called prehabilitation, can improve how well a patient recovers after surgery and increase how long they survive. Research has shown that prehabilitation is very beneficial for patients undergoing surgery for heart disease. However, it is not clear whether prehabilitation works for those with advanced ovarian cancer that are going to have surgery. Therefore, the investigators want to explore how a 4+ week exercise program performed while waiting for surgery for advanced ovarian cancer changes frailty and how a patient recovers after surgery. The investigators will specifically look whether the exercise program: 1) reduces how frail a patient is before surgery; 2) improves how well the patient recovers after surgery; and 3) affects the patient's chemotherapy treatment plan. This study will provide important information about the ability of prehabilitation exercise to improve surgical and treatment outcomes in women with advanced ovarian cancer. Overall, it is believed that exercise has the potential to improve the survival of advanced ovarian cancer patients.

Prehabilitation for Ovarian Cancer Patients

The Impact of Prehabilitation Exercise on Frailty and Treatment Outcomes in Ovarian Cancer Patients

Participant accrual calculated as % of patients referred divided by number of patients consented to participation

Participant attrition calculated as % of consented patients who complete a minimum of 4 weeks of pre-surgical exercise divided by number who withdraw

Participant program adherence calculated as % of minimum number of exercise sessions completed (e.g., 3 sessions/week for a minimum of 4 weeks for a total of 12 sessions) divided by total number of available exercise sessions over 12-week intervention

All exercise-related adverse and serious adverse will be recorded

Frailty will be assessed using the Clinical Frailty Scale (CFS). The CFS is a The CFS is a 9-point scale (1 - very fit, through very severely frail to 9 - terminally ill) developed for healthcare professionals to summarize the overall level of fitness/frailty of an individual. The CFS covers domains of mobility, energy, physical activity, and function. The higher the score on the CFS the more frail/less fit an individual is.

Surgical complexity will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines. Complexity scores will be interpreted as "low" (3 or fewer points), "intermediate" (4-7 points), and "high" (8 or more points).

Post-surgical outcomes will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines. Specific outcomes will include post-op glucose control, analgesia usage, pain, daily weight, early mobilization, and post-operative complications.

Surgical complications will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines. Specific outcomes will include length of hospital stay and number of readmissions.

Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment

Weight (kg) and height (m) will be used to calculate BMI

The six-minute walk will be used to calculate aerobic fitness

Muscular fitness will be assessed using the Canadian Society of Exercise Physiology's Physical Activity Training Protocol (CSEP-PATH) and will include the timed sit-to-stand and grip strength.

Health-related quality of life will be assess using the EuroQoL five dimensional questionnaire (EQ-5D-5L). The EQ-5D-DL measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; higher scores indicate higher problems

The Functional Assessment of Cancer Therapy for Ovarian Cancer (FACT-O) will be used to measure cancer-specific quality of life; 27-item questionnaire with higher scores indicating higher overall quality of life.

Dalhousie University

Nova Scotia Health Authority

Digestive System Diseases

Behaviors and Mental Disorders

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Quality of Life

Participants with esophageal cancer will be administered questionnaires, and medical charts will be accessed to collect study related data.

Questionnaires will be administered to participants

Assessment of patient-reported outcomes (PROs)

Geoffrey Buckle, MD, MPH

Michael Mwachiro, MBChB

Fatma F Some, MBChB, MMed

Gift Mulima, MBBS

Yona Ringo, MD, MMed

Alita Mrema, MD, MMed

Blandina Mmbaga, MD, MMed,PhD

Katherine Van Loon, MD, MPH

This study will be a carried out through a prospective observational cohort design in conjunction with researchers in the African Esophageal Cancer Consortium (AfrECC). The purpose of this research is to prospectively evaluate outcomes related to existing treatment strategies for esophageal cancer (EC) at participating sites within AfrECC.

SPECIFIC AIMS:

Aim 1: To describe the types of treatments administered for all patients diagnosed with EC at participating AfrECC sites, including chemotherapeutic regimens, radiation therapy, chemo-radiotherapy, esophageal stenting, esophagectomy, and basic supportive care.

Aim 2: To evaluate the effect of different EC treatment modalities on patient reported outcomes during and after completion of treatment.

Aim 3: To measure the effect of different treatment modalities on overall survival.

Treatment Outcomes of Esophageal Cancer

Descriptive statistics will be used to describe the proportion of EC patients receiving treatment with each modality at participating AfrECC sites. The investigators will assess the associations between demographic and clinicopathologic characteristic and treatment modalities employed (chemotherapy, radiotherapy, chemo-radiation, esophageal stenting, esophagectomy, supportive care alone, or a combination of these treatments)

The 6-item Modified Rosenblatt Index by Rosenblatt, et al. adapted for use within a resource-limited context evaluates EC related parameters scored on a Likert scale assessing presence and severity of symptoms: Odynophagia (0=no pain on swallowing to 3=severe pain); Dysphagia (0=normal, no dysphagia to 4=unable to swallow saliva); Regurgitation (0=never to 3=constant); Chest and/or Back Pain (0=no pain to 2=pain not relieved by non-narcotics or requiring opiate medication); World Health Organization (WHO) performance status/Overall Well-Being (0="A lot better" to 4="A lot worse"). Scores will be assessed at the following time points: Baseline, 1 month and 3 months after initiation of treatment, and every 3 months thereafter.

Survival will be defined as the time elapsed from date of diagnosis (either confirmed or date of diagnostic modality leading to presumptive clinical diagnosis) to date of death. For participants who are not deceased, censorship will be performed on the date when the participant was last known to be alive.

Westat

African Esophageal Cancer Consortium (AfrECC)

National Cancer Institute (NCI)

Celgene Corporation

University of California, San Francisco

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Nervous System Diseases

Breast Neoplasms

Pain

Musculoskeletal Pain

Breast Diseases

Skin Diseases

Muscular Diseases

Neurologic Manifestations

All Drugs and Chemicals

Aromatase Inhibitors

The hypnosis intervention involves three, face-to-face, hypnosis sessions delivered by doctoral-level psychology professionals

The attention control intervention is matched to the hypnosis intervention in terms of the amount of professional time received by patients.

The hypnosis intervention involves three parts. First, participants will receive three, face-to-face hypnosis sessions delivered by doctoral-level psychology professionals. The sessions are based on materials developed by experienced psychologists in the Integrative Behavioral Medicine Program at the Icahn School of Medicine at Mount Sinai. Second, participants will be taught how to use hypnosis themselves (self-hypnosis) to help manage their pain. Third, participants will receive a hypnosis recording to listen to in-between sessions and throughout the course of the study. At home hypnosis practice will be recommended.

Participants will be asked to complete questionnaires over a period of 12 months.

Hypnosis

The attention control intervention involves three face-to-face meetings with a doctoral-level psychology professional. During these sessions, participants will be asked to discuss with the interventionist their experience of taking aromatase inhibitors and associated musculoskeletal pain. The interventionist will not lead the patient in imagery, relaxation, evaluation of thought processes, or even simple discussion. Rather interventionists will allow the patient to direct the flow of the conversation and will provide support and empathy. Interventionist contact time in AC sessions will be identical to that in the hypnosis group. Overall, the attention control intervention will control for professional attention.

Participants will be asked to complete questionnaires over a period of 12 months.

Attention Control

Guy H Montgomery, PhD

The purpose of this study is to determine whether hypnosis is efficacious in reducing musculoskeletal pain in breast cancer survivors taking aromatase inhibitors, and by doing so, whether hypnosis can help survivors to be more adherent to their medication regimen.

The primary purpose of this study is to evaluate the efficacy of hypnosis for reducing musculoskeletal pain (MSP) in women taking aromatase inhibitors (AIs) for breast cancer. Research indicates that AIs are associated with musculoskeletal pain in up to 61% of breast cancer survivors. AI-associated MSP can include joint pain in the wrists, hands, and knees; carpal tunnel syndrome and trigger finger; and decreased grip strength, morning stiffness, and general muscle pain. MSP can lead to difficulty performing daily activities and can reduce quality of life in breast cancer survivors. This pain is not only aversive in and of itself, but also is associated with non-adherence to prescribed, daily AI regimens. In some studies, AI non-adherence estimates were as high as 50%.

At the present time, there is no "gold standard" treatment for AI-associated MSP. What is needed is an intervention that: reduces breast cancer survivors' MSP and helps them be more adherent to their prescribed AI regimen, does not have side-effects of its own, does not place a large time or financial burden on survivors, and which can be taught to survivors to practice on their own.

Hypnosis, a mind-body intervention, has been widely demonstrated to reduce pain. In fact, analgesia is perhaps the best known effect of hypnosis. Meta-analyses have consistently supported the efficacy of hypnosis for pain control, including chronic pain. Hypnosis also has a long tradition in cancer symptom management, especially for pain reduction. Hypnosis has been defined as an agreement between a person designated as the hypnotist (e.g., health care professional) and a person designated as the client or patient to participate in a psychotherapeutic technique based on the hypnotist providing suggestions for changes in sensation, perception, cognition, affect, mood, or behavior.

This study will examine whether or not hypnosis is helpful in reducing breast cancer survivors' AI-related MSP and in improving their adherence to their prescribed AI regimen. This study will also examine whether the hypnosis intervention is cost effective. To answer these questions, this randomized clinical trial will compare hypnosis (three sessions) to a non-hypnosis, attention control, empathic listening condition (three sessions). For each intervention, the first session will be approximately 40 minutes, and sessions 2 and 3 will be approximately 30 minutes each. Both interventions will be delivered face-to-face, by a doctoral-level psychology professional.

All participants will be taking AIs for breast cancer, will be experiencing some musculoskeletal pain since starting AIs (≥3 on a 10 point scale), and will be randomized to one of the two intervention groups. Study participants will be asked to complete measures of pain, AI adherence, and other behavioral and psychosocial measures over the course of 12-month period. The follow-up assessments will evaluate the clinical efficacy and cost-effectiveness of hypnosis versus professional attention.

Overall, this project is a critical step towards reducing the struggles of breast cancer survivors experiencing AI-related MSP, and associated non-adherence. By reducing MSP and improving AI adherence, the hypnosis intervention tested here has the potential to improve quality of life and well-being.

Hypnosis to Reduce Aromatase Inhibitor Pain and Improve Adherence

Hypnosis to Reduce Aromatase Inhibitor (AI) Associated Musculoskeletal Pain and to Improve AI Adherence: An RCT to Explore Efficacy and Cost Effects

The Brief Pain Inventory-Short Form (BPI-SF) is a self-report questionnaire assessing pain.

Adherence to aromatase inhibitors as measured by the eCap system. The eCap system is a medication event monitoring system that tracks medication usage without active patient input. eCaps record the date and time whenever the cap is opened to remove a pill.

AUSCAN is a self-report measure of musculoskeletal pain.

WOMAC is a self-report measure of musculoskeletal pain.

BCPT-MS is a self-report measure of musculoskeletal pain.

MARS is a self-reported measure of AI adherence.

Adapted TiC-P is a self-report measure to calculate costs associated with AI-related musculoskeletal pain.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prehabilitation for Ovarian Cancer Patients	NCT05364879	Prehabilitation Exercise Frailty Ovarian Cancer Surgical Compli... Treatment Outco... Enhanced Recove...	Prehabilitation...	18 Years -	Nova Scotia Health Authority
Treatment Outcomes of Esophageal Cancer	NCT05177393	Esophageal Canc...	Assessment of p...	18 Years -	University of California, San Francisco
Hypnosis to Reduce Aromatase Inhibitor Pain and Improve Adherence	NCT02657993	Breast Neoplasm... Musculoskeletal...	Hypnosis Attention Contr...	18 Years -	Icahn School of Medicine at Mount Sinai

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