Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients in the UC arm will not receive the study intervention (behavioral) and instead will receive care according to usual practice. This usually involves a brief office visit (approximately 5-10 minutes) with pertinent history and physical examination related to surgical/radiation recovery, review of the pathology and general instructions regarding the next step in follow-up.

behavioral intervention vs control Patients in the SCP-Int arm will be asked to attend a one-time appointment with a trained oncology nurse. The SCP-Int is comprised of a 30-minute nurse-led face-to-face intervention and the provision of a tailored PC-specific SCP (PC-SCP). Persistent effects and concerns that are identified will prompt the development of a tailored management plan captured within the PC-SCP. Relevant patient education materials will be linked electronically. Nurses will use motivational interviewing techniques to effective in increase healthy behaviors and empower the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support.

SCP-Intervention: Patients in the SCP-Int arm will attend a one-time appointment with a trained oncology nurse while the patients in the UC arm will receive care according to the hospital standards for follow-up care. The intervention will be delivered during a regular follow-up appointment, face-to-face and will inform and educate patients on self-management and support as well as promote access to and coordination of post-treatment care. The appointment will focus on empowering the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support. Nurses will integrate a number of "active behavior change ingredients" including the integration of motivational interviewing techniques which are effective in increasing healthy behaviors.

Survivorship Care Plan

Jennifer M Jones, PhD

Prostate Cancer Survivorship 360º is a collaboration-based initiative involving prostate cancer (PC) and survivorship researchers/clinicians from three Canadian prostate centers with the goal of identifying and tracking unmet supportive care needs of patients with localized PC and responding to these needs through survivorship care. The current randomized control trail (RCT) will focus on the development and evaluation of a facilitated electronic Prostate Cancer Survivorship Care Plan (PC-SCP). The aims of this project are: 1) to develop an appropriate and tailored SCP and transition care delivery process; and 2) to conduct an RCT to evaluate whether a personalized PC SCP intervention is more effective than usual care (UC) on patient activation (primary outcome) and access to services, self-Management support, satisfaction with information, HRQoL and cancer worry (secondary outcomes). Data from a multi-site prospective database- Prostate Cancer Survivorship Information System (PC360-IS) will be used to electronically populate the survivorship care plans. Overall, this proposal represents initial steps in uniting the country in sharing programmatic resources, data, expertise, and enthusiasm to transform survivorship care for men with PC and their families.

A Phase III RCT will evaluate the superiority of a Survivorship Care Plan (SCP) intervention (SCP-Int) compared with usual care (UC) after primary curative prostate cancer (PC) treatment. Each of the three sites has designated clinical study leads (AM, LG, and ST), high referral volumes and study leads' patients will be entered into the PC360-IS database which will be interfaced to the PC-SCP system to consolidate patient details and generate personalized SCPs. Research ethics approval will be obtained at each site. The trial will be registered with clinicaltrials.gov and reported using the CONSORT recommendations for trials.

The study population inclusion criteria are as follows: Histologically confirmed localized (T1-T3N0M0) PC; age at diagnosis \>18 years; treated with curative intent; treatment received \>1 month and \<6 months; disease-free as defined by absence of somatic disease activity parameters as per oncologist/urologist; consented to participate in the PC360-IS database. Exclusion Criteria: Patients who do not receive treatment and are followed by active surveillance; inability to complete study questionnaires.

Eligible patients will be randomly assigned to either the intervention arm or the control arm. A biostatistician will randomly assign participants to ensure that both the study RA and the participants are unaware of the treatment (SCP-int)/control groups (UC). Consenting patients will be registered into the study and randomized to receive either the SCP-Int or UC. Patients in the SCP-Int arm will be scheduled for the SCP-Int appointment on the same day as the patient's first (or second) follow-up appointment.

Eligible patients will be sent a study information letter which will be signed by the patient's urologist/ oncologist one month after the end of primary treatment. The RA will then contact patients to further explain the study. If agreeable, the patients will be sent consent forms, two stamped envelopes, and a baseline questionnaire to complete prior to the scheduled follow-up appointment. The patients will be asked to mail back the signed consent form and the completed questionnaire in each the envelopes provided.

Participants will have as much time as needed to decide if the participants would like to participate in the study prior to signing the consent form. The Research Analyst will obtain consent.

Planned trial interventions: SCP-Int: Patients in the SCP-Int arm will be asked to attend a one-time appointment with a trained oncology nurse (study nurse). To avoid additional travel and related costs to the patient, this appointment will be scheduled on the same day as the patient's follow-up appointment. The SCP-Int is comprised of two components: a 30-minute nurse-led face-to-face intervention and the provision of a tailored PC-specific SCP (PC-SCP). The intervention will be developed based on an established person-centred nursing framework with a tailored approach to customizing the intervention to the individual and will focus on the provision of self-management education and support and promote access to and coordination of post-treatment care including appropriate referrals to relevant programs and services (including TrueNTH solutions). The content of the PC-SCP will provide structure to the appointment. Persistent effects and concerns that are identified will prompt the development of a tailored management plan (i.e. patient education, referral to programs and services) captured within the PC-SCP. Relevant patient education and TrueNTH materials will be linked electronically. The appointment will focus on empowering the PC survivor to actively self-manage persistent treatment effects and to decrease the patients' risk of late effects by providing effective health information, support, and self-management support. Nurses will integrate a number of "active behaviour change ingredients" including the integration of motivational interviewing techniques which are effective in increasing healthy behaviours. Usual Care (UC): Patients in the UC arm will receive care according to usual practice. This usually involves a brief office visit (approximately 5-10 minutes) with pertinent history and physical examination related to surgical/radiation recovery, review of the pathology and general instructions regarding the next step in follow-up. In addition, patients in the UC arm will be able to access any supportive care programs or service available at the hospital according to usual practice. Currently, SCPs and dedicated transition appointments are not provided as part of a standard of care.

Allocation to trial groups: Patients will be allocated to either SCP-Int or UC by the Department of Biostatistics at Princess Margaret using a computer-generated randomization process (random blocks known only to statisticians). The research coordinator will telephone Biostatistics staff, who will not be involved in recruitment, to obtain the subject's assignment. Eligible patients from each site will be approached until the target number of participants is reached (or until a decision is made to stop recruitment).

Data collection: Data will be collected and analyzed according to the outlined project aims. Based on CONSORT criteria, a screening log will enable data collection on eligible and non-recruited patients with reasons for non-recruitment recorded when known. All data will be entered into a secured, password protected database within the UHN server. A separate database will be used for participant tracking to prevent re-approaching patients unnecessarily, and to ensure patients are receiving the questionnaire packages according to the study timeline.

Proposed primary and secondary outcome measures:

The outcome measures were chosen based on recent consensus and recommendations on the evaluation of SCPs. Patients will be assessed at baseline (T0), 6 (T1), and 12 (T2) months post-treatment. This questionnaire package is estimated to take 45 minutes to complete.

Primary Outcome: Patient activation will be measured using the Patient Activation Measure (PAM-13), a 13-items measure assessing knowledge, skills, beliefs, and confidence in managing health and health care. Patient activation is strongly related to a broad range of health-related outcomes. The primary outcome will be the overall score of the 13 items collected at T2.

Secondary Outcomes: a) Supportive care services utilization: using the Health and Social Services Utilization Inventory (HSSUI) modified for use in cancer populations. Service types are grouped into five categories: Health Professionals, Institutional/Hospital Programs; Nursing and Homemaker Support Programs; Other Community and Social Support Program/Resources (will include True NTH solutions); Programs/Resources.; b) Self-Management Support will be assessed using the Health Education Impact Questionnaire (heiQ), designed to evaluate outcomes from patient education and self-management interventions for people with chronic conditions; c) Satisfaction with Information will be measured with the 25-item European Organisation for Research and Treatment of Cancer Quality of Life INFO25 module which evaluates satisfaction with information received by cancer patients; d) Quality of Life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) which assesses PC-specific quality of life, and e) Cancer Worry will be measured using the Assessment of Survivors Concerns (ASC) measure which assesses fear of recurrence and health in cancer survivors.

Proposed sample size and justification: Our sample size calculations are based on 85% power with an alpha-level of 0.05, a standard deviation of 16 and a difference between groups of 8 points on the primary outcome (or half a standard deviation difference). Given these specifications, the required sample size is 146 patients (or 73 patients per arm). Assuming attrition of up to 20%, 180 patients will be recruited (or 90 patients per arm). Based on previous studies, we expect to enroll about 70% of eligible patients. The number of potentially eligible patients from participating sites is estimated to vary between 15-30 patients per month. Based on these estimates and our anticipated participation rates, we anticipate recruiting 20 patients per month with total recruitment completed within 9 months. We anticipate at least 80% will complete the 12-month post-treatment follow-up. We will use multiple strategies to promote retention and prevent attrition. Reasons for participant attrition will be documented.

Proposed analyses: Analyses will be performed adhering to the intention to treat principle. Descriptive statistics will be used to summarize baseline demographic and clinical characteristics of participants in both groups. Recruitment bias and possible differential attrition will be assessed by calculating the standardized differences between the two arms. The overall PAM-13 score at 12 months adjusted for the baseline score will be compared between the two arms using the t-test if the data appears normal or the Mann-Whitney test otherwise. A p-value\<=0.05 will be deemed significant. Secondary analyses of all scores at each time point will be conducted utilizing the mixed effect modeling to account for the intra-patient and intra-centre dependency due to the repeated measures within a patient and the multi-centre design. The residuals will be inspected and data will be transformed when necessary. Due to multiple testing for the secondary analyses a Hochberg-Benjamini approach will be used to ensure that the type I error rate does not exceed 0.05.

Cost-utility analyses: The analysis will also include a trial-based cost utility analysis. The health utility measured using the PORPUS-U and EQ-5D instruments will be used to provide patient-specific and group-mean estimates of quality-adjusted survival (Quality Adjusted Life Years). Costs from the payer perspective and from the societal perspective will be gathered using the HSSUI and an estimate of intervention costs. Inverse probability weighting will be used to adjust for induced dependent censoring. A net benefit regression approach will be employed to explore predictors of cost-effectiveness.

PC 360 Survivorship

Prostate Cancer Survivorship 360°

Vancouver Prostate Centre

McGill University Health Centre/Research Institute of the McGill University Health Centre

University Health Network, Toronto

Head and Neck Neoplasms

An individualized treatment summary and survivorship care plan (TSSP) will be prepared within a one-hour motivational interviewing (MI) counseling session with a clinical nurse specialist. Participants will be asked to identify their top three symptom/survivorship concerns. The intervention will address symptoms/survivorship care specifically tailored to the needs of head and neck cancer patients based on the best available evidence and consultation with patients and a multidisciplinary team of head and neck cancer specialists. Patient participants will engage in role play to empower them to follow-up with their healthcare provider regarding their survivorship care needs.

Individually tailored treatment summary and survivorship care plan provided within a 1-hour 1 hour counseling session with a clinical nurse specialist

Motivational interviewing counselling session

Agnieszka Dzioba, PhD

Danielle MacNeil, MD, FRCSC

Treatment summary and survivorship care plans (TSSPs) are poorly studied in Head and Neck Cancer (HNC) patients, and given the high frequency of unmet needs, this patient population has potentially the most to benefit from the implementation of TSSPs. A preliminary feasibility randomized control trial (RCT) at London Regional Cancer Program (LRCP) of 18 patients with HNC evaluating the implementation of TSSPs, found that patients assigned to the intervention group had a 15% higher rate of physician implementation of survivorship care needs compared to the usual care group (40% versus 25%, respectively). Results of the pilot study indicated that successful execution of TSSPs and counselling sessions for HNC patients is feasible. In follow up to the initial feasibility trial, the present investigation seeks to execute a large-scale single arm trial to evaluate a TSSP and counselling intervention specifically tailored to the needs of this vulnerable cancer population. The primary objective of the study is to evaluate the delivery of a TSSP during a one-on-one counselling session with HNC survivors to determine whether the intervention results in improved implementation of recommendations for HNC survivors. The investigators will aim to have 40% of survivorship recommendations implemented by 12 months post-intervention. Secondary study objectives will evaluate quality of life and satisfaction with care at 12 months post-intervention.

This study is a longitudinal single arm trial. This intention to treat design supports the implementation of Treatment Summary and Survivorship Care Plans (TSSPs) to cancer survivors. The single arm trial will be administered through the survivorship clinic at a tertiary level cancer center in Ontario. 90 patients with curable stage I-IV head and neck mucosal cancer (HNC) will be recruited to the study.

The intervention will consist of a survivorship care nurse motivational interviewing counseling session coupled with the provision of individualized TSSPs to patients and their health care providers.

The primary outcome will be physician implementation of survivorship care recommendations over the course of 12 months post-intervention assessed by quarterly patient surveys. Secondary outcomes will include adherence to recommended follow-up schedules, quality of life using validated measures, patient satisfaction with care, patient feedback on the utility of the TSSP and counselling session and physician feedback on the utility of the TSSP.

A prospective, single arm longitudinal trial at a single centre with 1 group of 90 adults. The study group will receive a one-hour treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of head and neck cancer patients delivered within a motivational interviewing counselling session with a clinical nurse specialist.

Survivorship After HNC: Evaluating Adherence to Follow-up

Survivorship After Head and Neck Cancer: A Single Arm Trial Evaluating Patient Care and Adherence to Follow-up

Physician implementation of survivorship care recommendations over the course of 12 months post-baseline, assessed by quarterly patient reports. Proportion of recommendations implemented by the health care provider will be recorded at 3, 6, and 12-months post-baseline.

The Satisfaction with Care and Information Scale evaluates participants' level of satisfaction with information provided to them on diagnosis and treatment-related issues, and survivorship issues, using a 5- point Likert scale (1 = very dissatisfied; 5 = very satisfied, range 1 to 5). The means of the responses are calculated to generate satisfaction scores for the following domains: Diagnosis, Oral/dental care, Long-term effects after treatment, Neck/shoulder mobility, Eating/speaking, Post-treatment care, Family/close relationships, and, Overall satisfaction with care and information.

The MDASI-HN includes a total of 28 items, with sub-scales, including a 13-item core cancer symptoms subscale, a 9-item head and neck-specific symptom subscale, and 6-items assessing the extent that symptoms interfere with daily living. Each item is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely).

Investigator developed survey evaluating patient satisfaction with and feedback on the utility of the TSSP and motivational interviewing counseling session

Investigator developed survey evaluating physician (primary care provider and oncologist) feedback on the utility of the TSSP in addressing head and neck cancer survivorship needs.

Western University, Canada

Doctor

Patients returning for early follow-up who did not receive SCP.

Patients returning for early follow-up who received a standard of care SCP.

Patients currently receiving treatment who will be enrolled to receive an "enhanced" SCP (eSCP) with additional information beyond ASCO guidelines tailored to patient concerns and preferences.

The eSCP includes a treatment summary section, a section detailing follow-up and test recommendations, a section on anticipated and potential side effects, as well as additional information specific to their experience/concerns. They will receive a patient education notebook outlining symptoms and their management that is tailored to those that the subject may be likely to experience during their survivorship care trajectory.

educational materials

Deborah H Allen, PhD, RN

The study will focus on survivorship care for head and neck cancer patients cared for within Duke Cancer Center clinics. Standardized survivorship care plans (sSCP) are being implemented based on the American Society for Clinical Oncology's criteria. These documents provide a summary of treatment received, and list side effects and follow-up information after cancer treatment. Taking advantage of this transition, the investigator will study three groups of patients: (a) early survivors treated before the sSCP was implemented, (b) early survivors treated after the sSCP was implemented, and (c) current patients who will receive an individualized enhanced SCP (eSCP), which will include additional information tailored to patient preferences. The investigators hypothesize that patients receiving enhanced survivorship care plans will increase their knowledge regarding their health care plan and wellness trajectory; increase their ability to identify the symptoms they most likely can expect as a result of their cancer treatment; and be more likely to engage in conversations with their PCP about healthy behaviors and screening guidelines.

Intervention (group receiving eSCPs) will be compared to 2 control groups: group receiving prior standard of care and standard of care SCP

Studying Survivorship Care Plans in Head and Neck Cancer

Comparison of Enhanced Survivorship Care Plans in a Head and Neck Cancer Clinic to Standard of Care

Assesses survivor knowledge of potential cancer or treatment-related symptoms and knowledge of healthy behaviors through the use of the Head and Neck Cancer Survivor Knowledge Scale

Assesses survivor knowledge of potential cancer or treatment-related symptoms and knowledge of healthy behaviors through the use of the Head and Neck Cancer Survivor Knowledge Scale in intervention group

Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist

Assesses distress through the use of the NCCN Distress Thermometer

Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist in the intervention group

Assesses distress through the use of the NCCN Distress Thermometer in the intervention group

Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form

Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form in the intervention group

Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head \& Neck (QLQ H\&N35)

Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head \& Neck (QLQ H\&N35) in the intervention group

Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale

Assesses information processing in cancer patients through the use of the EORTC QLQ Information Module (QLQ INFO25)

Assesses information processing through the use of the EORTC QLQ Information Module (QLQ INFO25)

Using open ended questions during a qualitative interview, survivors will provide their perception of how survivorship care plans were useful or not in their care

Using a documentation checklist developed by the study team, discussions on survivorship needs when returning to clinic will be assessed with a focus on symptom management or incorporation of healthy behaviors to reduce cancer recurrence

Duke University

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Atrophy

Breast Neoplasms

Infertility

Hot Flashes

Breast Diseases

Skin Diseases

Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.

Healthcare providers of young breast cancer participants randomized to the intervention arm will receive their patient's SCPR and access to the same additional web-based educational reproductive health information as their patient, including resource lists of helpful websites.

Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.

Healthcare providers of young breast cancer participants randomized to the waitlist control arm will receive access to the same web-based resources as their patient.

The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.

Reproductive Health Survivorship Care Plan (SCPR)

Web-based resource lists and text-based study adherence reminders

Control

H. Irene Su, MD MSCE

The investigators propose to test the efficacy of the Reproductive Health Survivorship Care Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation such as hot flashes, fertility concerns, limited contraception options and sexual problems. Together they have a major, negative impact on quality of life.

Despite substantial research, treatment guidelines and clinical expertise on these issues, most YBCS and their healthcare providers have limited guidance on how best to manage these reproductive health late effects. The research team has generated a practical, accessible, evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their providers to address this deficit in survivorship care. This clinical trial will test if YBCS who receive the web-based SCP-R are more likely than controls to improve on at least one of these reproductive health issues: hot flashes, sexual health, fertility concerns, and contraception.

Participants may be recruited from throughout the United States, as all study activities may be done remotely. It is not necessary to live in San Diego or visit UC San Diego to participate in the study.

YBCS who are interested in the study will be provided access to an online screening survey to determine eligibility. Eligible YBCS who consent to the study will be followed for 24 weeks.

Following a one-week study run in, YBCS participants will be randomized to the SCPR intervention or control arms and receive the corresponding interventions.

All YBCS participants will complete 3 study time points at enrollment, 12 and 24 weeks. At each time point, they will complete a web-based study questionnaire on medical and reproductive health. YBCS participants will also daily track their hot flashes via text messaging. YBCS participants will designate a healthcare provider with whom they would discuss reproductive health issues.

Designated healthcare providers will be approached to participate in the study. Those providers who enroll will complete 2 study assessments at weeks 0 and 24. At each study time point, HCP will be assessed for preparedness on managing reproductive health issues by a web-based questionnaire.

Reproductive Health Survivorship Care Plan

Intervening on Reproductive Health in Young Breast Cancer Survivors

Interested investigators may apply for deidentified data from this study

50% decrease in hot flash score. The hot flash score is calculated as the weighted sum of the number of hot flashes in each severity category multiplied by a severity-exclusive weight (1-mild, 2-moderate, 3-severe, 4-very severe). The minimum is 0 and there is no maximum. For example a woman can experience an unlimited number of hot flashes per day. Higher score indicates worse outcome.

Fertility concerns subscale score \<=3. Scores for the fertility subscale calculated by averaging responses (range 1-5) to the 3 subscale questions. The minimum score is 1, the maximum score is 5, Higher scores indicate worse outcome.

Use of World Health Organization Class I or II contraceptive methods (intrauterine devices, female sterilization, male partner sterilization, combined hormonal contraception, progestin implants or injections)

The Vulvovaginal Atrophy Score is a 4-item scale on vaginal dryness, soreness, irritation and dyspareunia experienced in the prior 4 weeks\]. Each item has a 4-point Likert scale response (0-none, 1-mild, 2-moderate, 3-severe). The scale is summarized by averaging responses, with higher scores indicating a greater level of vaginal atrophy.

University of California, San Diego

Professor of Obstetrics, Gynecology, and Reproductive Sciences

Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.

Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.

SCPR Intervention

Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.

Control: Web-based resource lists and text-based study adherence reminders

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Irene Su, MD MSCE

Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.

Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence

Number of Participants With a 50% Decrease in Hot Flash Score

Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3

Number of Participants Using a WHO Class I or II Contraception

Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score

Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of websites, followed by reproductive health prompts and study adherence reminders for 24 weeks.

Healthcare providers of young breast cancer participants randomized to the intervention arm will receive their patient's SCPR and access to the same additional web-based educational reproductive health information as their patient, including resource lists of helpful websites.

Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.

Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.

Healthcare providers of young breast cancer participants randomized to the waitlist control arm will receive access to the same web-based resources as their patient.

Control: Web-based resource lists and text-based study adherence reminders

Healthcare Provider Preparedness Scale

Depression (PHQ-8)

Social Support (MOS Social Support)

Insomnia Scale

Female Sexual Function Inventory

Confidence for Managing Reproductive Health Issues Scale

Menopause Quality of Life (MENQOL)

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Lung Neoplasms

Lymphoma

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Lymphosarcoma

Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).

Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors.

Receive telephone-based educational counseling session

Educational Intervention

Questionnaire Administration

Eric Chow

This trial studies how well self-generated survivorship care plans and telehealth education works in improving knowledge and self-efficacy in cancer survivors living in rural areas. Patients living in rural areas often face barriers to survivorship care and report unmet needs. A survivorship care plan created by the patient (self-generated) may help them to better transition from oncology to primary care and improve communication between care teams in order to meet these needs and create better health outcomes. Telehealth is a way of delivering health care services from a distance, including patient education. Combining a self-generated survivorship care plan with telehealth education may help to improve knowledge and self-efficacy in cancer survivors.

OUTLINE:

Patients complete a questionnaire at baseline (paper, online, or telephone-based) and medical records are reviewed.

Patients are then randomized to 1 of 2 arms.

ARM I: Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).

ARM II: Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care.

PRIMARY CARE PROVIDERS: Primary care providers complete a questionnaire about perceptions of the SCP and self-efficacy in providing survivorship care.

ONCOLOGY CLINIC STAFF: Administrators and medical providers will be asked to complete the adapted Organizational Readiness to Change Assessment (ORCA) instrument (that measures Evidence and Context only) and participate in a qualitative interview about perceptions of implementation of survivorship care.

After completion of study, patients are followed up at approximately 8 weeks.

Personnel other than the statisticians and lay health educators

Survivorship Care Plans and Telehealth Education for the Improvement of Access to Cancer Survivorship, the IMPACT Study

IMPACT: Improving Access to Cancer Survivorship Via Telehealth

Will measure the accuracy of participants' SCPs by comparing their self-reported medical history collected via questionnaire, with data abstracted from medical records. Accuracy will be reported by percentage of missing data in the self-generated SCP compared to medical records, and percentage of incorrect data in the self-generated SCP compared to medical records.

The effects of the intervention versus (vs.) control on participant perceived self-efficacy will be measured at baseline and at the end of the study via a questionnaire using the PROMIS Global 10 and health related self-efficacy scales.

The effects of the intervention vs. control on survivorship knowledge will be measured at baseline and at the end of the study via a questionnaire.

The effects of the intervention vs. control on PCP self-efficacy towards survivorship care will be measured at baseline and at the end of the study via a questionnaire using the PROMIS Global 10 and health related self-efficacy scales.

Assess oncology practitioners' and clinic administrators' views on utility and feasibility of implementing SCPs in target clinics, using the ORCA (Organizational Readiness to Change Assessment) instrument and qualitative interviewing

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Behaviors and Mental Disorders

Quality of Life

The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),

ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.

Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care

In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support

Enhanced Survivorship Care Plan

Lixin Song, RN, PhD

The purpose of this research study is to examine the feasibility of the enhanced survivorship care plans (ESCPs, regular SCPs with the a web-based couple-focused symptom self-management project (PERC) or National Cancer Institute prostate cancer web links) and to conduct an initial benefit assessment of enhanced survivorship care plans among prostate cancer patients transitioning from active treatment to post-treatment self-management, and their partners.

Participation of this study lasts for about for 16 weeks. Depending on participants' need for information, it takes 10-30 minutes of their time each week to review the information about prostate cancer.

Eligible and consented patients with newly treated localized prostate cancer and your partner (couples) are randomly assigned to the regular survivorship care plan (SCPs) with the NCI website or the enhanced survivorship care plans (SCP plus the web-based prostate cancer education program, PERC) groups. They complete baseline (T1, prior to randomization) and 4-month post-T1 follow-up measures (T2).

Methods: A two-group randomized controlled pretest-posttest design will be used and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized prostate cancer and their partners. First, the investigators will assess the feasibility of ESCP by recruitment, enrollment, and retention rates, program satisfaction with the ESCP, and perceived ease of use of the ESCP. To achieve the secondary aim, the ESCP users will be compared with the standardized SCP users and assess their primary outcomes of QOL (overall, physical, emotional, and social QOL), secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms), and number of visits to post-treatment care services at T1 and T2. The primary and secondary outcomes are assessed using measurements with sound psychometrical properties. The investigators will use a qualitative and quantitative mixed methods approach to achieve the research aims.

Conclusions: The results from this study will help design a definitive randomized trial to test the efficacy of the ESCPs, a potentially scalable program, to enhance supportive care for prostate cancer patients and their families.

Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Will evaluate the percentage of patients and partners successfully consented and completing the baseline survey among all people approached for the study

Will evaluate the percentage of participants successfully following protocol, defined as completing the Follow-Up survey at the end of the study period among those who have been enrolled into the study (who completed the baseline).

The usage of Web-Based Intervention Sessions is determined by the percentage of participants who logged into the study website among those who have been randomly assigned to the intervention group. Patient-Reported Symptoms are determined by patient's responses on their appraisal of prostate cancer symptoms and general symptoms. 1=patient reported the symptom and the symptom webpage reviewed; 0=patient reported the symptom and no related webpage reviewed OR patient did not report the symptom but the webpage reviewed

Program satisfaction determined by the 11-item Participant Satisfaction Scale measured the level of program satisfaction. The first to tenth items ranged from 1=not satisfied to 5=extremely satisfied. The eleventh item ranged from 1=extremely not to 4=definitely yes. Higher total score indicates greater program satisfaction

The 16-item Program Usability measures participants' assessment of their agreement with the ease of use of the program in terms of its general features, content, and navigation. The ranges of the total scores are (3,15), (4,20), (9,45) for general features, content, and navigation, respectively. The score of individual item ranges from1=strongly disagree to 5=strongly agree. Higher score indicates greater perceived ease of use.

Change in QOL determined using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. Change from baseline is the post-Baseline values minus the Baseline value.

The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC will be used to measure change in appraisal of symptoms scores among patients from Baseline (T1) to T2 (4 months post T1). EPIC contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing opposite results by role: patient with better appraisal of symptoms and partner with worse appraisal of symptoms. Change from baseline is the post-Baseline values minus the Baseline value.

The 19-item Risk for Distress-general symptoms is a subscale of the Risk for Distress Scale. It measures how much trouble the participant has with the general symptoms such as pain, fatigue, and etc. The total score ranges between 0 and 38, with higher scores indicating worse appraisal of symptoms. Change from baseline is the post-Baseline values minus the Baseline value.

The total number of prostate cancer-related followup visits, emergency room use and readmissions.

The Lewis Cancer Self-Efficacy used to measure change in participants' feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1). Participants rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.

The Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more informational support. Change from baseline is the post-Baseline values minus the Baseline value.

The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more emotional social support. Change from baseline is the post-Baseline values minus the Baseline value.

The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more instrumental support. Change from baseline is the post-Baseline values minus the Baseline value.

Change in Dietary Risk Assessment scores used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants are asked how often they consume different foods over the past month or week and respond using a Likert Scale ranging from 1=never to 4=routinely. The total score range: 8-32. Higher scores indicate better health behaviors in nutrition.

Change in Physical Activity Assessment scores used to measure changes in physical activity from Baseline (T1) to T2 (4 months post T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants are asked how often they engage in exercises and physical activity over the past month or week and respond using a Likert Scale, ranging from 1=never to 4=routinely. The total score range: 9-36. Higher scores indicate better health behaviors in physical activity.

UNC Lineberger Comprehensive Cancer Center

No death happened during the study period, and thus, the All-Cause Mortality is zero

The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),

Survivorship Care Plan: Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care

Survivorship Care Plan (SCP)

ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.

Enhanced Survivorship Care Plan: In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support

Enhanced SCP (ESCP)

White

Black

Other

Race/Ethnicity, Customized

Less than college

Bachelor's Degree

Graduate Degree (Master's PhD, JD, MD, etc.)

Education

Employment Status

<= $60,000

>$60,000

the range of household's current annual income

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PC 360 Survivorship	NCT03017456	Prostate Cancer	Survivorship Ca...	18 Years -	University Health Network, Toronto
Survivorship After HNC: Evaluating Adherence to Follow-up	NCT06127784	Head and Neck C... Survivorship	Motivational in...	18 Years -	Western University, Canada
Studying Survivorship Care Plans in Head and Neck Cancer	NCT03106090	Head and Neck C...	educational mat...	18 Years -	Duke University
Studying Survivorship Care Plans in Head and Neck Cancer	NCT03106090	Head and Neck C...	educational mat...	18 Years -	Duke University
Reproductive Health Survivorship Care Plan	NCT02667626	Breast Cancer Hot Flashes Sexual Dysfunct... Fertility Contraception	Reproductive He... Control	18 Years - 45 Years	University of California, San Diego
Survivorship Care Plans and Telehealth Education for the Improvement of Access to Cancer Survivorship, the IMPACT Study	NCT04081779	Breast Carcinom... Colorectal Carc... Lung Carcinoma Lymphoma Prostate Carcin...	Survivorship Ca... Educational Int... Questionnaire A...	18 Years -	Fred Hutchinson Cancer Center
Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program	NCT04350788	Prostate Cancer	Survivorship Ca... Enhanced Surviv...	18 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center
Self-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer	NCT04428905	Lung Non-Small ... Stage I Colorec... Stage I Lung Ca... Stage IA1 Lung ... Stage IA2 Lung ... Stage IA3 Lung ... Stage IB Lung C... Stage II Colore... Stage II Lung C... Stage IIA Color... Stage IIA Lung ... Stage IIB Color... Stage IIB Lung ... Stage IIC Color... Stage III Color... Stage III Lung ... Stage IIIA Colo... Stage IIIA Lung... Stage IIIB Colo... Stage IIIB Lung... Stage IIIC Colo... Stage IIIC Lung...	Quality-of-Life... Questionnaire A... Survivorship Ca... Telemedicine	18 Years -	City of Hope Medical Center
Study of Survivorship Care Plans and Outcomes in Underserved Breast Cancer Survivors	NCT01627366	Breast Cancer	Survivorship Ca...	21 Years -	Jonsson Comprehensive Cancer Center
Study of Survivorship Care Plans and Outcomes in Underserved Breast Cancer Survivors	NCT01627366	Breast Cancer	Survivorship Ca...	21 Years -	Jonsson Comprehensive Cancer Center

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