Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants received one-on-one breast cancer awareness education; one-on-one monthly Breast Self-Examination (BSE) training; general breast cancer screening recommendations; and general lifestyle modification recommendations

Participants received Standard care as described in the SC arm above in addition to individualized breast cancer risk assessment, individualized breast cancer risk counseling, and lifestyle risk reduction recommendations

Individualized breast cancer risk assessment: The Nigerian Breast Cancer Study (NBCS) absolute risk prediction model was used to predict the 5-year and lifetime breast cancer risks of the participants. The model utilized individual breast cancer risk factors.

Individualized breast cancer risk assessment

Individualized breast cancer risk counselling: The Principal Investigator (PI) and other trained risk counsellors discussed the results of the NBCS risk prediction model with participants and counselled them about the risk of developing breast cancer. The

Individualized breast cancer risk counselling

OLADOSUN A OJENGBEDE, FMCOG, FWACS, FICS, M.B.B.S

OLADELE O.O KALE, B.A, M.B, B.Ch, B.A.O

IKEOLUWAPO O. AJAYI, MBBS; PhD

CELIA IMARIA AGWAI, M.P.H; Ph.D.

DEZHENG HUO, PhD

OLUFUNMILAYO OLOPADE, M.D., F.A.C.P

The study will be a randomized controlled trial. The aim of the study is to determine the Breast Cancer (BC) risk and to evaluate the effect of BC risk counseling on lifestyle changes and adherence to risk-reduction practices among first-degree female relatives of BC patients in South-West Nigeria. This study's research questions are:

* What are the Nigeria Breast Cancer Study (NBCS) and Gail models estimates of the BC risk of first-degree female relatives of BC patients in South-West, Nigeria?
* What are the effects of BC risk assessment and counseling on adherence to breast screening recommendations among first-degree female relatives of BC patients in South-West, Nigeria?
* What are the effects of BC risk assessment and counseling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of BC patients in South-West, Nigeria?
* What is the knowledge, attitudes, and perception of first-degree female relatives of BC patients in South-West Nigeria towards genetic testing and BC etiology?
* What factors predict breast screening among first-degree female relatives of BC patients in South-West Nigeria?
* What factors predict the time to first BC screening (post-intervention) among first-degree female relatives of BC patients in South-West Nigeria?

Participants will be randomized into the control arm (standard care) and intervention arms of the study. The intervention arm of the study will have a BC risk assessment followed by individualized BC risk counseling. In addition, the intervention arm will receive BC awareness and MammaCare® BSE training. The control arm will receive only standard care comprising BC awareness and MammaCare® BSE training. Both study arms will receive BC screening recommendations and lifestyle modification recommendations.

We hope that the BC risk counseling will improve BC screening practices and modification of risk behaviors and this hypothesis will be tested.

For this study, first-degree female relatives are mothers, sisters, and daughters of BC patients

Nigerian Breast Cancer Risk-Reduction Study

Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria

Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to breast screening practices

Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to lifestyle risk reduction practices

Statistical analysis will be carried out to determined the independent variables predicting BSE

Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening

Semi-structured questionnaires will be used to determine the perception of familial BC risk among participants

Semi-structured questionnaires will be used to determine the knowledge of familiar BC risk among participants

Semi-structured questionnaires will be used to determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among participants

Lagos State University Teaching Hospital (LASUTH)

Obafemi Awolowo University Teaching Hospital

Lagos University Teaching Hospital (LUTH)

University College Hospital, Ibadan

University of Ibadan

Epidemiologist

1. Patient survivorship education via telehealth with the cancer center
2. Ongoing patient-tailored education program by MyChart within the EHR patient portal
3. Structured interactive phone communication between the research RN at the cancer center and community PCP clinic
4. In-person visit with the PCP clinic for survivorship care.

In-person visit at specialty survivorship clinic

1) Patient survivorship education via telehealth with the cancer center- The research registered nurse (RN) will discuss the contents of the survivorship care plan and coordination between the cancer center and PCP clinic. 2) Ongoing patient-tailored education program by MyChart within the EHR patient portal- Patients will be asked to select survivorship topics of interest from a panel (e.g. school issues, fertility, fatigue, physical activity, single kidney health, emotions/coping) that will then be sent over 1 year. 3) Structured interactive phone communication between the research RN at the cancer center and community PCP clinic- The discussion will explain the patient's cancer history, tumor recurrence monitoring schedule, individualized risk of late effects and surveillance schedule, psychosocial challenges, health behaviors, and coordination between the cancer center and PCP clinic. 4) In-person visit with the PCP clinic for survivorship care.

Multi-level Intervention of shared model of survivorship care

Participants will be contacted by study staff at their cancer center to schedule an in-person visit at the survivorship clinic that will include a comprehensive history focused on cancer-related medical and psychosocial issues, physical examination, ordering of recommended surveillance for late effects, and delivery of hard copy of their survivorship care plan.

Comparison Group

Nina Kadan-Lottick, MD, MSPH

Jacqueline Casillas, MD

Jenna Demedis, MD

Burton Appel, MD

Andrew Smitherman, MD

More than 80% of childhood cancer survivors develop serious or life-threatening late effects after cancer therapy, but \<20% receive recommended survivorship care offered at cancer center survivorship clinics. In a shared care model, the investigators propose to investigate an innovative multi-level intervention consisting of: 1) patient survivorship education via telehealth with the cancer center, 2) ongoing patient-tailored education program within the electronic health record patient portal, 3) a structured interactive phone communication between the cancer center and the primary care clinic, and 4) an in-person visit with the primary care clinic for survivorship care with the goal of achieving high rates of adherence to recommended surveillance for late effects, as well as improving patient and physician knowledge and self-efficacy. If this scalable intervention demonstrates patient completion of recommended care comparable to cancer center survivorship clinics, this innovative study has the enormous potential to deliver recommended care to a larger proportion of childhood cancer survivors and reduce survivorship care disparities, while engaging p to integrate survivorship care as part of overall, lifelong health maintenance.

More than 80% of childhood cancer survivors (CCS) develop serious or life-threatening late effects. Yet \<20% of CCS receive recommended survivorship care, despite the availability of consensus guidelines for lifelong surveillance for late effects starting 2 years post-therapy. The "gold standard" cancer center-based survivorship clinic provides high-quality care to CCS who attend, but patients avoid reminders of their past cancer and lack knowledge and self-efficacy for survivorship care. Other barriers include travel distance, inadequate insurance, and out-of-pocket costs-these structural issues contribute to health disparities. Partnering with community primary care provider (PCP) clinics in a shared model of care is a promising strategy to overcome these barriers, but PCPs lack knowledge, self-efficacy, and interactive communication with the cancer center and are confused about the division of care responsibilities. This intervention is scalable and distance-based, is informed directly by patient and PCP barriers and preferences from previous studies, and is boosted by a nationwide explosion in telehealth services precipitated by the COVID-19 crisis. The proposed randomized controlled trial will enroll 240 CCS 2.0-4.0 years post-chemotherapy/radiation to investigate an innovative multi-level intervention (i.e., interpersonal and organizational levels) consisting of 1) patient survivorship education via telehealth with the cancer center, 2) ongoing patient-tailored education program within the electronic health record (EHR)'s patient portal, 3) a structured interactive phone communication between the cancer center and the PCP clinic (with 1-year follow-up call), and 4) an in-person visit with the PCP clinic for survivorship care. The comparison group will be randomized to an in-person visit with their cancer center survivorship clinic. This study includes 4 centers with high proportions of subgroups vulnerable to survivorship care disparities (i.e., rural, Black, Latinx, Spanish-speaking, socioeconomically disadvantaged). Both groups will be asked to begin recommended surveillance for late effects within 1-year post-randomization, separate from tumor recurrence monitoring by the primary oncologist. The Specific Aims are to Aim 1- Demonstrate patient completion of guideline-recommended surveillance tests in intervention participants is not inferior, i.e. within 10%, to that in the comparison group; Aim 2- Achieve greater 1) patient knowledge, self-efficacy, and activation and 2) PCP knowledge and self-efficacy with survivorship care among intervention participants and their PCPs compared to the comparison group; and Aim 3- Ascertain process outcomes for the 1) patient and 2) PCP clinic. Outcomes will also be assessed among subgroups with survivorship care disparities. Transformative Impact: If the intervention demonstrates patient completion of recommended survivorship care comparable to cancer center survivorship clinic, the study has the enormous potential to deliver recommended lifelong care to a larger proportion of CCS and reduce survivorship care ies, while engaging patients and PCPs to integrate survivorship care as part of overall, lifelong health maintenance.

A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship

BRidging Information Divides and Gaps to Ensure Survivorship: the BRIDGES Randomized Controlled Trial of a Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship

The proposed research will include data from 240 survivors of childhood cancer. The dataset will include (1) demographic data; (2) cancer diagnosis and treatment data; (3) adherence to survivorship care data; (4) knowledge, self-efficacy, and activation data; and (5) process outcomes (feasibility, fidelity, acceptability) data. In compliance with the National Institutes of Health Principles and Guidelines document, the investigators will readily provide all relevant protocols, publications, and the underlying primary data (to the extent possible as guided by the IRB) supporting publications to other academic investigators upon request. To maintain the privacy of the human subjects, data will de-identified. Should any intellectual property arise that requires a patent, the investigators will ensure that the technology (materials and data) remains widely available to the academic research community.

The investigators will conduct semi-structured, qualitative interviews with 1) 40 intervention participants and 2) 40 PCP clinics to generate feedback regarding the intervention (e.g. timing, duration, usability). Interviews will explore acceptability of the intervention and how to improve intervention efficacy.

The investigators will assess adherence to surveillance recommended by the Children's Oncology Group Long-term Follow-up Guidelines. The primary analysis will be on tests completed by patients, and not just ordered by physicians, because that is the most meaningful indicator of patient adherence to guidelines

Patient Knowledge Survey developed by Kadan-Lottick et al. for the Childhood Cancer Survey Study which is a 9-item survey regarding treatment history, risk of late effects, need for survivorship care, and purpose of the survivorship care plan. Note that results will not be reported on a scale.

Patient Knowledge Survey developed by Kadan-Lottick et al. for the Childhood Cancer Survey Study which is a 9-item survey regarding treatment history, risk of late effects, need for survivorship care, and purpose of the survivorship care plan. Note that results are not reported on a scale.

Stanford Chronic Disease Self-Efficacy Scale (score range 1-10, higher score indicates greater self-efficacy) to be administered to patients and proxies

The 13-item Patient Activation Measure (PAM) will be administered to participants to evaluate the level of patient activation, i.e. patient self-reported knowledge, skill, and confidence for self-management of one's health or chronic condition. Scores range from 0-100 with higher scores reflecting greater patient activation.

Survey consisting of questions regarding the PCPs' familiarity with the surveillance guidelines and confidence in providing survivorship care. Note that results are not reported on a scale.

Patients will complete a survey regarding process outcomes (i.e., feasibility, fidelity, acceptability) associated with the multi-level intervention. Note that results are not reported on a scale.

Primary care physicians will complete a survey regarding process outcomes (i.e., feasibility, fidelity, acceptability) associated with the multi-level intervention. Note that results are not reported on a scale.

University of North Carolina, Chapel Hill

University of Colorado, Denver

Hackensack Meridian Health

NYU Langone Health

Seattle Children's Hospital

Georgetown University

Each site will complete an 18-month Baseline Phase, in which patients and sites are observed during a period of usual care, prior to introducing the C4 Program intervention. In this phase, a sample of newly diagnosed patients will be recruited and enrolled in the Baseline Group, and data will be collected on them via patient surveys and EHR data abstraction over a period of four months for most outcomes, except for overall survival, which will be assessed at 12 months after diagnosis

new sample of newly diagnosed patients (excluding anyone from the Baseline Phase) will be recruited and enrolled in the Implementation Group, and the same data will be collected on them that was collected in the Baseline Group, at the same time points

C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services.

C4 Program

Yvonne Taul, RN

Timothy Mullett, MD

The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services.

Comprehensive Connected Cancer Care (C4): Intervention Evaluation

The FACT-G7 is a 7-item version of the Functional Assessment of Cancer Therapy-General (FACT-G), a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. The survey assesses the impacts of cancer therapy in four domains: physical, social/family, emotional, and functional. Higher scores represent higher quality of life.

1 year survival after diagnosis (12 months)

Merck Sharp & Dohme LLC

Timothy Mullett

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Immune System Diseases

Behaviors and Mental Disorders

Prostatic Neoplasms

Neoplasm Metastasis

Hypersensitivity

Urologic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Quality of Life

All Drugs and Chemicals

Hormones

Intervention: Single, Semi-Structure Interview to identify and define the key attributes associated with treatment options that would warrant trade-off evaluation. These will be used to create the first version of the questionnaire

Intervention: Single, "Think Aloud Interview" Interview. These will be analysed using an inductive thematic analysis by at least two researchers. Common themes will be extracted by researchers individually and then discussed and agreed.

Intervention: Single, Discrete Choice Experiment Questionnaire at Enrollment Visit

Semi-Structured Interview Healthcare Professional

Semi-Structured Interview Patients

Think Aloud Interview Patients

Discrete Choice Experiment (DCE) Patients

Hashim Ahmed, PhD, FRCS

Systemic therapy (i.e Androgen Deprivation Therapy with Docetaxel, Enzalutamide, Apalutamide or Abiraterone Acetate) has increased overall survival in men with hormone-sensitive metastatic prostate cancer.

Novel local cytoreductive treatments and metastasis directed therapy are being evaluated, these can confer additional harm, but might improve survival.

We aim to elicit men's preferences for and willingness to accept trade-offs between potential improved survival and cytoreductive treatment risks using a 'discrete choice experiment'.

OBJECTIVES: To determine the attributes associated with treatment that are most important to men with hormone-sensitive metastatic prostate cancer (mPCa). To determine men's preferences for, and trade-offs between, the attributes (survival and side-effects) of different treatment options in metastatic prostate cancer including systemic therapy, local and metastases-directed physical therapies.

PHASE: Prospective multi-centre observational cohort

DESIGN: Discrete choice experiment, single-visit, electronic questionnaire design

SAMPLE SIZE: Multi-centre Stage (Stage 3) n = 300 patients

POPULATION: Men with newly-diagnosed metastatic prostate cancer who have not consented to a form of local cytoreductive or metastasis directed therapy.

Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research

Patients' Preferences in the Treatment of Hormone-sensitive Metastatic Prostate Cancer: a Discrete Choice Experiment

Qualitative work derived from "Think Aloud Interviews". Treatments include radiotherapy, surgery, ablation and metastasis directed therapy.

Utility values obtained via multinominal logit estimates from discrete choice experiment

Derived from discrete choice experiment finding analysed alongside reported outcomes from ongoing therapeutic trials.

University of Aberdeen

Imperial College London

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Aneel Bhangu, PhD

Joana Simoes, Master

Observational study to assess barriers for colorectal cancer treatment compliance in India, including quantitative assessment of catastrophic expenditure incidence and qualitative assessment of financial and non-financial barriers.

Objective: To identify a vulnerable group of colorectal cancer patients in India who cannot afford or are unable to comply with a treatment plan for colorectal cancer.

Aims:

1. To identify the proportion of CRC patients suffering catastrophic expenditure due to out-of-pocket payments for cancer treatment.
2. To determine the proportion of patients who are unable to comply with the treatment plan for CRC, at 6 weeks, 3 months and 6 months after diagnosis.
3. To identify barriers and solutions to CRC treatment compliance. Design: A mixed-methods study comprising quantitative pilot data from 3 tertiary cancer centres and qualitative work from interviews with patients and healthcare professionals.

Participants: Patients diagnosed with primary colorectal cancer.

Outcomes:

Primary outcome:

• Incidence of catastrophic expenditure due to out-of-pocket payments for cancer care at 3 timepoints: 6 weeks, 3 months and 6 months after CRC diagnosis.

Secondary outcomes:

* Compliance to the initial treatment plan at three timepoints: 6 weeks, 3 months and 6 months after CRC diagnosis.
* Patients and healthcare professionals perspectives on patient compliance to CRC treatment.
* Identify the 5 main drivers (items charged to the patient) of CRC treatment cost.
* Colorectal cancer stage at the time of diagnosis.

ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment

Catastrophic expenditure (CE) will be defined as out of pocket payments for CRC treatment greater than 40% of patient income (assessed by an in-person questionnaire led by a researcher).

A compliant patient will be defined as undergoing or having completed the planned treatment agreed at the time of diagnosis or MDT discussion.

5 most expensive items or services during colorectal cancer treatment

AJCC (American Joint Committee on Cancer) guidance - 8th edition

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nigerian Breast Cancer Risk-Reduction Study	NCT05834933	Risk Reduction ... Breast Cancer Health Behavior Health Care Uti... Health Knowledg...	Individualized ... Individualized ...	20 Years - 75 Years	University of Ibadan
A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship	NCT05448560	Childhood Cance... Survivorship Health Care Uti... Health Knowledg... Adherence, Pati...	Multi-level Int... Comparison Grou...	2 Years -	Georgetown University
Comprehensive Connected Cancer Care (C4): Intervention Evaluation	NCT06326567	Cancer Health Care Uti...	C4 Program	18 Years -	University of Kentucky
Comprehensive Connected Cancer Care (C4): Intervention Evaluation	NCT06326567	Cancer Health Care Uti...	C4 Program	18 Years -	University of Kentucky
Nigerian Breast Cancer Risk-Reduction Study	NCT05834933	Risk Reduction ... Breast Cancer Health Behavior Health Care Uti... Health Knowledg...	Individualized ... Individualized ...	20 Years - 75 Years	University of Ibadan
Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research	NCT04590976	Prostate Cancer... Radiotherapy Si... Surgery Urologic Cancer Quality of Life Patient Satisfa... Health Care Uti...	Semi-Structured... Semi-Structured... Think Aloud Int... Discrete Choice...	18 Years -	Imperial College London
ColoRectal Cancer in India: catastrOphiC expenDIture and Referral Pathways infLuencE on Presentation and Treatment	NCT04517032	Colorectal Canc... Treatment Compl... Health Care Uti...		18 Years -	University of Birmingham

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