Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Targeted mailed educational materials (C).

C + patient activation (PA) consisting of (1) smartphone app with HIPAA compliant survivorship care plan that can be viewed, printed, or emailed to their primary care provider; and (2) two-way (interactive) tailored text messages with links to video vignettes discussing the primary barriers to breast MRI and mammography.

C + PA + PCP activation (PA+PCP) with physician materials about breast cancer risk in this population along with national and international guidelines for breast cancer surveillance.

Smartphone-based materials including text messages and supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to a doctor about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials.

Patient activation

Mailed educational print materials sent to the participants' primary care doctors about health risks and recommendations for medical screening for adult women who were treated for a childhood cancer with chest radiation.

Primary care physician activation

Control

Kevin C Oeffinger, MD

Jennifer S Ford, PhD

The primary purpose of this study is to determine the impact of maximizing patient and primary care provider (PCP) activation on breast cancer surveillance rates among women previously treated with chest radiotherapy (RT) for a childhood cancer. This is an 18-month, 3-arm randomized controlled trial using a smartphone intervention with data being collected at baseline and 18-months through patient and provider surveys and medical record review. Eligible women treated for a childhood cancer with chest RT will be randomly sampled from the Childhood Cancer Survivor Study (CCSS) and randomly selected to one of three groups: control, patient activation (PA) using a smartphone-based intervention, or patient activation + primary care provider activation (PA+PCP) which will include physician materials about breast cancer risk in this population along with guidelines for breast cancer surveillance. Participants in all groups will receive mailed targeted print materials as an educational resource about their previous chest radiation and breast cancer screening recommendations. The primary outcome is a medical record confirmed breast MRI and mammogram with the goal of increasing the rate of women completing the national guideline-based recommended combination of breast MRI and mammogram. This study will test the hypothesis that women in the PA and PA+PCP groups will have significantly higher rates of breast cancer surveillance (breast MRI and mammogram) than women in the control group. In addition, the hypothesis that women in the PA+PCP group will have significantly higher rates of breast cancer surveillance than women in the PA group will also be tested.

Participants will be randomly assigned, in a ratio of 1:1:1, to one of the three groups: control, patient activation (PA), or patient activation + primary care provider activation (PA+PCP). Participants will remain in the group they are randomized to with no crossover throughout the study.

Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

EMPOWER-II: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

Participants will be recruited from an established cohort (Childhood Cancer Survivor Study), and therefore individual participant data will not be available to other researchers.

Measures patient activation and includes: believing one has an active role to play, having the confidence and knowledge to take action, taking action, and staying the course under stress.

The Breast Cancer Surveillance Practices instrument (questionnaire) was developed as part of an effort supported by NCI funding (R21CA106972) and published in JAMA (Oeffinger KC, et al. JAMA, 301:404-414, 2009). The section regarding knowledge of the recommendations was then adapted for the EMPOWER-I Study, supported by NCI R01134722, and includes 3 items to determine if participants have (1) heard of mammography for breast cancer screening (yes, no, not sure), at what age women like the participant should begin getting a mammogram, and how frequently (multiple time frames).

Elicits a rank order of the most relevant and important barriers of breast MRI and those associated with mammogram, for those women who did not obtain the recommended screening. The barriers are presented as a list of 13 statements in which there are 5 ranges of measure provided for each statement. The scale ranges include "Not at all," "A little bit," "Moderately," "Quite a bit," and "Extremely." The value/response of "Not at all" is considered to be the better outcome, whereas the value/response of "Extremely" is considered to be the worst outcome for the barrier scale. The scale is not combined to compute a total score, since responses are scored for each statement individually.

The Pros and Cons of mammography is a 13-item instrument developed by Rakowski et al (Prev Med 1997). It was used in our Breast Cancer Surveillance Practices instrument (Oeffinger KC, et al. JAMA, 2009). The pros and cons scores (5-point Likert items) are converted to T-scores and then presented as a summary Decisional Balance. For EMPOWER-I Study, we adapted this instrument to also assess a woman's perspective on the pros and cons of breast MRI. This resulted in a 7-item instrument that is analyzed similar to the Pros and Cons of Mammography and presented as a Decisional Balance.

This one-item question asks participants whether their mother, sister(s), or daughter(s) have been diagnosed with breast cancer.

This item was developed for the aforementioned Breast Cancer Surveillance Practices instrument and is a one-time question with asking women how they estimate their risk of breast cancer (with five responses: much more than the average woman, more than the average woman, same as the average woman, less than the average woman, much less than the average woman).

Developed for the EMPOWER-I study, the questionnaire asks participants at the end of the study whether they saw a health care provider during the 18-month study period, whether they discussed breast cancer screening with a provider, and whether the provider responded to the information (5-point Likert). Each of these items will be analyzed separately.

Will be measured using the adapted and shortened version of the Positive Affect Negative Affect Scale (PANAS). We will focus on emotions related to managing health.

To determine the Stage of Adoption (Change) for breast cancer surveillance, participants will be asked when they plan to have their next mammogram and/or breast MRI (following the completion of the study).

Measures confidence in discussing breast surveillance with the primary care physician and obtaining the recommended screening using items developed by Champion and colleagues.

Age, gender, years in practice, and practice setting.

Most PCPs have taken care of only a few childhood cancer survivors. To ascertain their past experience with caring for this population, we ask PCPs how many childhood cancer survivors they have in their practice panel (0, 1-2, 3-5, \>5).

Comfort level with caring for adult survivors of childhood cancer (Likert scale)and familiarity with available guidelines (Likert scale).

Using a hypothetical vignette of a 29-year old female patient treated for Hodgkin lymphoma with chemotherapy and chest RT, questions will be asked about screening for thyroid dysfunction, breast cancer, and cardiac dysfunction.

Replication costs of the intervention and health services from the intervention per participant.

National Cancer Institute (NCI)

St. Jude Children's Research Hospital

Memorial Sloan Kettering Cancer Center

City University of New York, School of Public Health

University of California, San Francisco

Columbia University

Duke University

Targeted mailed educational materials (C).

Control: Mailed educational materials.

Control (C)

C + patient activation (PA) consisting of (1) smartphone app with HIPAA compliant survivorship care plan that can be viewed, printed, or emailed to their primary care provider; and (2) two-way (interactive) tailored text messages with links to video vignettes discussing the primary barriers to breast MRI and mammography.

Patient activation: Smartphone-based materials including text messages and supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to a doctor about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials.

Control: Mailed educational materials.

Patient Activation (PA)

C + PA + PCP activation (PA+PCP) with physician materials about breast cancer risk in this population along with national and international guidelines for breast cancer surveillance.

Patient activation: Smartphone-based materials including text messages and supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to a doctor about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials.

Primary care physician activation: Mailed educational print materials sent to the participants' primary care doctors about health risks and recommendations for medical screening for adult women who were treated for a childhood cancer with chest radiation.

Control: Mailed educational materials.

Patient Activation + Primary Care Provider Activation (PA+PCP)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race

Race/Ethnicity, Customized

United States

Region of Enrollment

Kevin Oeffinger, MD

Percentage of Women Who Completed a Breast MRI and Mammogram

Patient Activation Measure (PAM) - Questionnaire

Breast Cancer Surveillance Practices - Knowledge of Recommendations (Questionnaire)

Barrier Scales (Questionnaire)

Pros and Cons of Mammography and Breast MRI (Questionnaire)

Family History of Breast Cancer (Questionnaire)

Perception of Breast Cancer Risk (Questionnaire)

Communication With PCP (Questionnaire)

Affect

Future Breast Screening Intentions

Self-Efficacy

Primary Care Provider Demographics

Primary Care Provider Experience

Primary Care Provider Comfort Level

Primary Care Provider Knowledge

Economic Measurements

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants assigned to the intervention arm will receive the True North Peer Navigation intervention.

Participants assigned to the control arm will receive usual care and access to an online health resource library. After completion of the study, they will receive the True North Peer Navigation intervention.

Participants in the intervention group will receive ongoing support from a trained peer navigator for 3 months after completing treatment for prostate cancer via the True North Peer Navigation website. Participants will be matched with a trained peer navigator who assesses needs and barriers to care, provides practical, informational, and emotional support, and empowers them to take a proactive role in their health. Participants will also have access to a health resource library on the True North Peer Navigation website that contains local and national resources about prostate cancer.

Peer navigation

Participants in the active wait list control group will receive usual care and access to a health resource library on the True North Peer Navigation website that contains local and national resources about prostate cancer. After completion of the study, patients in the active wait list control group will be matched with a peer navigator.

Active wait list control

Jackie Bender, PhD

One in nine Canadian men will be diagnosed with prostate cancer (PC) in their lifetime. Although all treatment options can be effective in controlling the disease, treatment side effects such as problems with erections and controlling the bladder can significantly affect men's quality of life. Many men with PC say they do not get relevant information and emotional support, and experience gaps in care when dealing with these difficult issues. Previous studies have shown that cancer patient navigation improves access to care and support, and reduces healthcare costs. The investigators developed True North Peer Navigation - a peer navigation program for men with PC and a peer navigator training course. Men are matched online with a trained peer navigator who provides practical information and emotional support through the cancer journey. A pilot evaluation showed that it is highly acceptable to patients and peer navigators, and improves patient quality of life, social support and ability to manage their health. In this study, the investigators will conduct a randomized controlled trial of the True North Peer Navigation program in cancer centres in Ontario, British Columbia and Nova Scotia. Patients will be randomly assigned to receive True North Peer Navigation or an active wait list control consisting of usual care with access to information on the True North Peer Navigation website. The investigators will evaluate the effect of the True North Peer Navigation program on patient outcomes such as their ability to take a more active role in their health, quality of life, social support and use of health care services. In addition, the investigators will evaluate how True North Peer Navigation was implemented, the experiences patients and peer navigators, the factors that make it easier or harder for people to deliver the program to patients in different settings, as well as the cost of delivering the program, which will help us learn how to spread the program across the country.

Background: Prostate cancer (PC) is a highly prevalent condition affecting 1 in 9 Canadian men. While the 5-year survival rate for PC is 93%, treatment-related side effects, such as sexual dysfunction and urinary incontinence, can significantly affect quality of life. Men with PC lack access to relevant information and emotional support, and report gaps in supportive care when dealing with these difficult issues. Previous research has shown that cancer patient navigation improves the timeliness of care and support, and reduces healthcare costs. Engaging volunteer cancer survivors as navigators is less costly, provides peer support, and benefits the navigator by improving their psychosocial health. The investigators developed True North Peer Navigation - an evidence-based peer navigation program for men with PC and a competency-based peer navigator training course. Men are matched online with a trained peer navigator who assesses needs and barriers to care, provides practical, informational, and emotional support, and empowers them to take a proactive role in their health. A pilot study showed True North Peer Navigation is highly acceptable to patients and peer navigators, and associated with improvements in quality of life, social support and patient activation to manage health.

Aim: This project aims to advance knowledge on the effectiveness and implementation of a web-based peer navigation program for men after treatment for PC.

Specific Objectives:

1. To determine the effect of True North Peer Navigation on patient outcomes in men with PC; and
2. To evaluate the delivery of True North Peer Navigation in terms of fidelity, cost, and the experiences of patients and peer navigators, and to identify barriers and facilitators to its implementation in oncology settings.

Methods: Guided by the SPOR Patient Engagement Framework, the investigators will conduct a type-1 hybrid effectiveness-implementation study at cancer centres in Ontario, British Columbia and Nova Scotia. For objective 1, the investigators will conduct a pragmatic randomized controlled trial to evaluate the impact of True North Peer Navigation compared to an active wait list control on patient activation (primary) and needs, quality of life, anxiety, depression, fear of recurrence, social support, and access to services (secondary). Two hundred and forty patients (n=120 per arm) with PC will be recruited after treatment. Outcomes will be assessed at baseline (T0), 3-months (T1) and 6-months (T2). Objective 2 will involve a mixed-method process evaluation to investigate implementation fidelity, patient and navigator experiences, and cost-effectiveness of True North Peer Navigation, and to assess implementation barriers and facilitators with stakeholders informed by the Consolidated Framework for Implementation Research and the Theoretical Domains Framework.

Significance: True North Peer Navigation is an innovative solution to an important service gap in the lives of men with PC. This study has the potential to generate important evidence and strategies to support the implementation of peer navigation programs to improve the health outcomes of men with PC in Canada.

This is a 2-arm pragmatic randomized controlled trial with an active wait-list control, and an embedded process evaluation. Participants in the intervention group will receive the True North Peer Navigation intervention. Participants in the active control group will receive access to an online health resource library and will be offered the True North Peer Navigation intervention after study completion.

A Web-based Peer Navigation Program for Men With Prostate Cancer

A Web-based Peer Navigation Program for Men With Prostate Cancer: A Hybrid Effectiveness-Implementation Trial

An estimation of the combined health utility values derived from responses from the European Quality of Life, 5 Dimensions, 5 Levels (EQ-5D-5L) and length of life experienced by patient, between measurement time points.

The total cost of publicly funded healthcare utilization (outside of delivery of the intervention) by patient while enrolled in the study. Number of times patient accessed publicly funded healthcare resources while enrolled in the study will be estimated based on the data gathered from the Health System Service Utilization Inventory (HSSUI). Resource use volumes will be used to micro-cost resource use costs such as physician care, allied health professional care, hospital care and pharmaceuticals.

Incremental cost of the intervention (i.e., delivery of the peer navigation program not related to volunteer time, such as administrative costs, training costs, and overhead costs) will be estimated per patient.

The primary outcome will be change in Patient Activation from baseline to 3 months. Patient Activation will be measured using the Patient Activation Measure (PAM). Higher scores represent a better outcome.

Change in Patient Activation from baseline to 6 months will be assessed.Patient Activation will be measured using the Patient Activation Measure (PAM). Higher scores represent a better outcome.

Change in Supportive Care Needs from baseline will be assessed at 3 months and 6 months separately. Supportive Care Needs will be measured with the 34-item Supportive Care Needs Survey-Short Form (SCNS-SF) with a 7-item prostate cancer add-on module. Higher scores represent a worse outcome.

Change in health-related quality of life from baseline will be assessed at 3 months and 6 months separately. Health-related quality of life will be measured with the European Quality of Life, 5 Dimensions, 5 Levels (EQ-5D-5L) overall utility score. Higher scores represent a worse outcome.

Change in Prostate Cancer Specific Quality of Life from baseline will be measured t 3 months and 6 months separately. Prostate Cancer Specific Quality of Life will be measured using the overall Patient-Oriented Prostate Utility Scale (PORPUS) score. Higher scores represent a worse outcome.

Change in Anxiety from baseline will be assessed at 3 months and 6 months separately. Anxiety will be measured using the Generalized Anxiety Disorder scale (GAD-7). Higher scores represent a worse outcome.

Change in Depression from baseline will be assessed at 3 months and 6 months separately. Depression will be measured using the depression module of the Patient Health Questionnaire (PHQ-9). Higher scores represent a worse outcome.

Change in Social Support from baseline will be measured at 3 months and 6 months separately. Social Support will be measured using the Enriched Social Support Scale, a multidimensional measure of perceived social support (ESSI). Higher scores represent a worse outcome.

Change in Fear of Cancer Recurrence from baseline will be assessed at 3 months and 6 months separately. Fear of Cancer Recurrence will be measured using the Fear of Cancer Recurrence Inventory -Short Form Scale (FCRI-SF). Higher scores represent a worse outcome.

University of British Columbia

Dalhousie University

University of Toronto

Canadian Cancer Society (CCS)

Canadian Partnership Against Cancer

Movember Foundation

Walnut Foundation

Prostate Cancer Support - Toronto

Prostate Cancer Group - Burnaby

University Health Network, Toronto

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

C + patient activation (PA) consisting of interactive tailored text messages with links to videos and resources

C + PA + PCP activation (PA+PCP) with physician materials about colorectal cancer risk in this population

Interactive text messages with links to videos (e.g. colorectal cancer screening options, cost of colorectal cancer screening, perspective from a cancer survivor, why regular appointments are important for cancer survivors) and resources (e.g. helpful websites) are sent to participants

Faxed educational materials (e.g. current colorectal cancer screening recommendations, frequently asked questions, insurance letter template, cover letter with overview of patient's cancer treatment history) sent to primary care providers

Primary care provider activation

Tara O Henderson, MD, MPH

Karen Kim, MD, MS

The primary purpose of this study is to assess the best method for encouraging high-risk cancer survivors to get screened for colorectal cancer at the recommended age.

This is a 12-month, 3-arm randomized controlled trial of 315 Childhood Cancer Survivor Study (CCSS) survivors using a text message intervention with data collected at baseline and 12 months through patient and provider surveys and interviews and a medical record review. Participants will be randomly assigned to one of three groups: control, patient activation (PA) using a text message/video intervention, or patient activation + primary care provider activation (PA + PCP) which will include providing primary care providers with resources about colorectal cancer risk in this population. All participants will receive electronic resources about their previous cancer treatment and colorectal cancer screening recommendations.

The primary outcome is the proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if the Cologuard is positive) within 12 months of enrolling on the study, as measured via self-report questions in the end of study questionnaire. The study will test the hypothesis that, compared to controls, survivors randomized to the PA and PA + PCP activation groups will have significantly higher rates of completion of colorectal cancer screening.

ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study

This will be measured by self-report on a questionnaire given at 12 months.

The study team will confirm if participants had a colonoscopy or cologuard test by reaching out to the medical site where the participant was screened, and requesting the medical record confirmation.

Consolidated Framework for Implementation Research (CFIR) questions are included in the 12-month questionnaire for participants, the 12-month questionnaire for their primary care providers, and the end of study interviews for the participants, primary care providers, and other medical office staff. CFIR questions are meant to measure 5 domains: intervention characteristics, outer setting, inner setting, characteristics of individuals, and process.

In this study, the potential moderators include patient characteristics, such as age, gender, educational attainment, health insurance coverage, types of insurance, chronic health conditions, and race/ethnicity as well as PCP factors such as knowledge, years in practice, and practice setting. The potential mediators in this study may include the patient's perception of involvement in decision making, health insurance coverage, and whether the patient reviewed the study resources and videos. This will be measured through data collected via the baseline and 12 month questionnaires as well as data previously collected via the St. Jude Childhood Cancer Survivor Study.

We will collect data on the replication costs of the intervention and health services from the intervention per participant. The costs of the intervention (e.g. intervention materials, personnel time, and texting costs) will be collected by the University of Chicago team via a cost spreadsheet. The cost of the health services will be collected via the 12-month questionnaire; participants will be asked to share information about the types of medical visits they have had since joining the study.

Hunter College of City University of New York

The Hospital for Sick Children

University of Chicago

Colonic Neoplasms

Rectal Neoplasms

Patients in experimental group receive standard care and one-hour educational session. Patients are provided knowledge of

* healthy diet
* malnutrition, its prevalence and consequences for patients with CRC undergoing CT
* side effects impairing nutrition intake during CT treatment.
* prevention and self-care methods of the side effects Teach-back is used to verify participants' understanding. Empowering effect is confirmed by using active listening and asking patients' individual side effects, self-care strategies and need of additional knowledge in the beginning of the session and supporting patients' self-care methods when they have been applicable and effective. Additional knowledge of each theme is offered. To reinforce the intervention effect patients receive after the first CT a self-monitoring diary including assessment of side effects prevalence and intensity (NRS 0-10) before and after the self-care strategies. They return diaries by the 5th cycle of CT.

Patients in control group receive standard care, information of

* general CT induced side effects and their self-care; nausea, diarrhoea, obstipation and sores in the mouth, peripheral neuropathy symptoms, local venous irritation, heart symptoms, mucous and skin irritation
* side-effects' self-monitoring, fluid intake, medication dose changes, effect of CT
* weight control
* taste alteration
* cold sensitivity
* variable diet
* dietary supplements
* available dietitian services

They receive a self-monitoring diary, which includes only side effects and their intensity (NRS 0-10).

This is an educational intervention which aims to answer the questions:

1. In patients with CRC what is the effect of empowering education versus standard education on knowledge level in 4 months follow-up?
2. In patients with CRC what is the effect of empowering education versus standard education on activation level related to nutrition impact side effects' self-care in 4 months follow-up?
3. In patients with CRC what is the effect of empowering education versus standard education on malnutrition risk in 4 months follow-up?
4. In patients with CRC what is the effect of empowering education versus standard education on QoL in 4 months follow-up?

Educational nursing intervention on nutrition intake related chemotherapy induced side-effects' self-care among the patients with colorectal cancer

Helena Leino-Kilpi, PhD

The prevalence of malnutrition is common among patients with colorectal cancer. Chemotherapy induced side effects may impact negatively on nutrition intake thus increase the risk of malnutrition and serious complications for patients. Purpose is to test the effect of empowering education on activation and knowledge level among patients with colorectal cancer during the chemotherapy. Secondary outcomes are quality of life and malnutrition.

A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures is used to measure the effectiveness of face-to-face education on nutrition intake related chemotherapy induced side-effects' self-care compared to standard care. Eligibility criteria are adult patients diagnosed with colorectal cancer and receiving intra venous chemotherapy treatment. Patients are recruited in one university hospital outpatient clinic in Finland. Experienced oncology nurse delivers the intervention two weeks after the first chemotherapy. Primary outcomes are activation in self-care and knowledge level. Secondary outcomes are quality of life and risk of malnutrition measured at baseline (M0) and after eight (M1) and 16 weeks (M2) after the intervention.

The study will provide knowledge of nurse-led educational intervention on self-care among patients with colorectal cancer. The findings will contribute to patient education and self-care, thus better quality of life.

The prevalence of malnutrition is common among patients with colorectal cancer. Chemotherapy induced side effects (nausea, vomiting, pain, mouth sores, fatigue, diarrhea, constipation, distress) may impact negatively on nutrition intake thus increase the risk of malnutrition thus serious complications for patients. Nurse-led empowering education may have positive effect on activation and knowledge level and enhance self-care of this patient group. Studies of nurse-led interventions that may enhance nutrition intake are scarce. Therefore, purpose of this study is to test the effect of educational nursing intervention on activation and knowledge level among patients with colorectal cancer during the chemotherapy. Secondary outcomes are quality of life and risk of malnutrition.

A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures is used to measure the effectiveness of face-to-face education on nutrition intake related chemotherapy induced side-effects' self-care compared to standard care. Eligibility criteria are adult patients diagnosed with colorectal cancer and receiving intra venous chemotherapy treatment. Patients are recruited in one university hospital outpatient clinic in Finland. Experienced oncology nurse delivers the intervention two weeks after the first chemotherapy. Primary outcomes are activation in self-care and knowledge level. Secondary outcomes are quality of life and malnutrition risk measured at baseline (M0) and after eight (M1) and 16 weeks (M2) after the intervention.

The study will provide knowledge of the effectiveness of nurse-led empowering educational intervention on self-care related to chemotherapy-induced side effects that may deteriorate nutrition intake among patients with colorectal cancer. The findings will contribute to patient education and self-care, thus better quality of life.

A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures

Participants are blinded after assignment to interventions, those in intervention and control groups are not aware which treatment they get.

Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy

Educational Nursing Intervention on Nutrition Impact Side-effects' Self-care Among Patients With Colorectal Cancer During Chemotherapy: A Research Protocol for a Randomised Controlled Trial

Better nutritional status is related to better treatment effect and better well-being, which may lead to better adherence to treatment schedule (Ravasco et al. 2012). Data is collected from patients' records.

Worse nutritional status is related to greater morbidity (Ravasco et al. 2012). Data is collected from patients' records.

Knowledge is seen as essential for empowerment (Rankinen et al. 2014; Castro et al. 2016). It is assumed that knowledge level is better in the intervention group compared to control group. Knowledge test was developed in the research group, which included an oncologist, a dietitian, oncology nurses and a researcher. The instrument includes 15 items (yes/no, right answer=1 point, wrong answer=0 points).

Activated individuals have the knowledge, skills and confidence to self-manage their health. PAM shows how ready, willing and able an individual is to manage his or her health and healthcare.It is assumed that patients in the intervention group are more activated to self-care their side effects. The activation score is based on a 0-100 point scale. A change of 3-4 points is associated with the difference between engaging and not engaging in particular behaviors. Activation self care is rated from 1 to 4 (1= low activation level; believing the patient role is important, 2=low activation level; having the confidence and knowledge necessary to take action, 3=moderate activation level; actually taking action to maintain and improve one's health, and 4=high activation level; staying the course even in stressful situations)(InsigniaHealth 2017).

Nutrition consultations have affected positively on patients' food intake and nutritional status (Kiss \& Krishnasamy 2014; Tu et al. 2013; Ravasco 2011, 2012). Patients with a total score of ≥3 are classified as nutritionally at risk. It is assumed that malnutrition risk is lesser in the intervention group compared to control group.

The risk of malnutrition is strongly associated with QoL in cancer patients initiating chemotherapy (Calderon et al. 2018).The FACT-C questionnaire consists of 36 items on a 5-point Likert scale in four areas of well-being: physical (0-28 points), social (0-28 points), emotional (0-24 points), functional (0-28 points) and CRC subscale (0-28 points). Higher score means better QoL (34 points=low level, 34-68 points= satisfactory, 68-102 points=average and 102-136 points=high)(Ganesh et al. 2016; Goździewicz et al. 2017).

Helsinki University Central Hospital

University of Turku

Principal Investigator

Blood and Lymph Conditions

Immune System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Sarcoma

Lymphoma

Testicular Neoplasms

Endocrine Gland Neoplasms

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Soft Tissue Sarcoma

Lymphosarcoma

Participants assigned to the intervention arm will the receive digital peer navigation intervention.

Participants assigned to the control arm will receive usual care. After completion of the study, they will have the option to receive the digital peer navigation intervention.

Participants in the intervention group will receive ongoing support from a trained peer navigator for 3 months after completing treatment for cancer. Participants will be matched through a digital app with a trained peer navigator who assesses needs and barriers to care, provides practical, informational, and emotional support, and empowers them to take a proactive role in their health. Patients will communicate with their peer navigator through digital direct messaging, videoconference or by telephone. Participants will also have access to a health resource library on the digital app that contains local and national resources about cancer.

Digital Peer Navigation

Bojana Petrovic, MPH

Adolescents and young adults (AYA) diagnosed with cancer experience unique challenges after completing treatment and face distinct barriers to optimal care and support. These challenges include higher levels of symptom burden and treatment complications, interrupted education, careers and relationships, and financial hardship. AYA lack access to peers, relevant information and emotional support, and report gaps in care when dealing with these difficult challenges.

Digital peer navigation could help to address the needs of AYA and overcome barriers to care and support. The PI developed True North Peer Navigation (TrueNTH-PN), an evidence-based digital peer navigation program for men with prostate cancer and online peer navigator training course. The goal of this project is to adapt TrueNTH-PN for AYA and evaluate its feasibility to overcome barriers to care and support, and enhance patient activation among AYA during the challenging post-treatment phase.

In partnership with AYA cancer survivors, the Canadian Cancer Society, Young Adult Cancer Canada, a digital app design firm and technology provider, our cross-Canada team will: (1) Adapt and evaluate the usability of the TrueNTH-PN app for AYA; (2) Adapt and evaluate the effectiveness of the Peer Navigator Training Course for AYA; and (3) Determine the feasibility, acceptability and preliminary effectiveness of the new AYA-PN program among post-treatment AYA cancer survivors.

This project will produce an innovative solution to an important service gap in the lives of AYA with cancer. It has the potential to address the support needs of AYA, overcome barriers to care, and empower AYA to take proactive role in managing their health. In addition, it will give rise to AYA peer navigators with specialized skills, which could fill gaps in disrupted education and career paths, and help to attain future goals.

Background: Adolescent and young adult (AYA) cancer survivors experience unique challenges and face distinct barriers to optimal post-treatment survivorship care and support which can impede their recovery. These include high levels of symptom burden and treatment-related complications, interrupted education, careers and relationships, and financial toxicity. AYA lack access to peers, relevant information and emotional support, and report gaps in care when dealing with these difficult challenges. Previous research has shown that patient navigation improves the timeliness of care and support, and reduces healthcare costs. Engaging trained volunteer cancer survivors as peer navigators minimizes resource requirements, is preferred by AYA over professional support, and benefits the navigator by improving their psychosocial health. The PI developed True North Peer Navigation (TrueNTH-PN), an evidence-based digital peer navigation program for men with prostate cancer and online competency-based peer navigator training course. Patients are matched through a digital app with a trained peer navigator who assesses needs and barriers to care, provides practical, informational, and emotional support, and empowers a proactive approach to health. TrueNTH-PN has been shown to be highly acceptable to prostate cancer patients and peer navigators, and associated with improvements in patient activation, social support and quality of life.

Aim: This study aims to adapt and evaluate a digital peer navigation program for AYA cancer survivors to overcome barriers to care and support, and enhance patient activation during the post-treatment survivorship phase.

Specific Objectives: This 3-phase project will: (1) Adapt and evaluate the usability of the TrueNTH-PN app for AYA; (2) Adapt and evaluate the effectiveness of TrueNTH-PN peer navigator training course for AYA; and (3) Determine the feasibility, acceptability and preliminary effectiveness of the new AYA peer navigation program (AYA-PN).

Methods: We will adopt an iKT approach with patients, Canadian Cancer Society and Young Adult Cancer Canada as partners, along with a digital app design firm and technology provider. For objective 1, informed by Barrera and Castro's cultural adaptation framework and user-centred design, we will engage AYA in a critical assessment of the existing TrueNTH-PN app to identify areas in need of adaptation for AYA, co-design content and processes adaptations, and conduct user-testing. For objective 2, we will tailor and validate the relevance of the course content for AYA; recruit, screen and train 20 AYA cancer survivors to be peer navigators; and informed by the Kirkpatrick training program framework, evaluate the training course using pre-post questionnaires to assess knowledge and self-efficacy for navigator competencies. For objective 3, we will conduct a pilot RCT of the new AYA-PN program compared to wait list control with an embedded process evaluation to determine: 1) feasibility; 2) acceptability; and 3) preliminary effectiveness on patent activation, supportive care needs, quality of life, anxiety/depression, social support and post-traumatic growth. Eighty AYA (n=40 per arm) will be recruited after completing treatment. Outcomes will be assessed at baseline (T0) and 3-months (T1). In addition, we will evaluate patient-navigator interactions, app usage, and cost-effectiveness, and conduct semi-structured interviews with patients and navigators informed by the Consolidated Framework for Implementation Research to capture experiences, explore mechanisms of action and identify implementation barriers and facilitators.

Significance: This study will produce an innovative solution to an important service gap in the lives of AYA with cancer. It is highly aligned with the CCS priority in AYA survivorship care, the Pan-Canadian Cancer Survivorship Research Agenda, and the SPOR mandate to make research more responsive to the needs of Canadians.

Digital Peer Navigation for Adolescents and Young Adults With Cancer

Digital Peer Navigation for Adolescents and Young Adults With Cancer: A Feasibility Study

Health utility will be measured with the EQ-5D.

Supportive care needs will be measured with the Supportive Care Needs Survey (SCNS-SF34).

Anxiety will be measured with the Generalized Anxiety Disorder scale (GAD-7).

Depression will be measured with the Patient Health Questionnaire (PHQ-9).

Social support will be measured with the ENRICHD Social Support Instrument (ESSI).

Young Adult Cancer Canada

Pharmaceutical Solutions

All Drugs and Chemicals

The control arm will receive standard treatment.

Individuals within the intervention will receive standard care and access to the Breast Cancer Treatment Application (BCTA) for 13 months.

The development and implementation of the Breast Cancer Treatment Application (BCTA) will facilitate a secure approach to virtual care for Breast Cancer patients, provide patient specific treatment education and facilitate evaluation of Patient Reported Outcome Measures.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer	NCT03435380	Breast Neoplasm... Early Detection...	Patient activat... Primary care ph... Control	25 Years -	Duke University
Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer	NCT03435380	Breast Neoplasm... Early Detection...	Patient activat... Primary care ph... Control	25 Years -	Duke University
A Web-based Peer Navigation Program for Men With Prostate Cancer	NCT05041504	Prostate Cancer	Peer navigation Active wait lis...	-	University Health Network, Toronto
ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study	NCT05084833	Colorectal Canc... Early Detection...	Control Patient activat... Primary care pr...	30 Years -	University of Chicago
Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy	NCT04160650	Patient Empower... Patient Activat... Self Care Cancer of Colon Cancer of Rectu...	Educational nur...	18 Years - 85 Years	University of Turku
Digital Peer Navigation for Adolescents and Young Adults With Cancer	NCT06193369	Lymphoma Breast Cancer Testicular Canc... Sarcoma	Digital Peer Na...	18 Years - 40 Years	University Health Network, Toronto
A Web-based Peer Navigation Program for Men With Prostate Cancer	NCT05041504	Prostate Cancer	Peer navigation Active wait lis...	-	University Health Network, Toronto
Digital Peer Navigation for Adolescents and Young Adults With Cancer	NCT06193369	Lymphoma Breast Cancer Testicular Canc... Sarcoma	Digital Peer Na...	18 Years - 40 Years	University Health Network, Toronto
A Web-based Peer Navigation Program for Men With Prostate Cancer	NCT05041504	Prostate Cancer	Peer navigation Active wait lis...	-	University Health Network, Toronto
At-home Breast Oncology Care Delivered With E-health Solutions	NCT05989477	Patient Engagem... Patient Activat... Patient Reporte...	At-home Breast ...	18 Years -	University Health Network, Toronto
Impact of a Health Technology Intervention on Patient Activation in Multiple Myeloma	NCT05673083	Multiple Myelom... Multiple Myelom... Multiple Myelom... Multiple Myelom...		18 Years -	All4Cure
ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study	NCT05084833	Colorectal Canc... Early Detection...	Control Patient activat... Primary care pr...	30 Years -	University of Chicago

Spots Global Cancer Trial Database for patient activation