Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

12-week online support led by a healthcare professional

12-week online support group in a peer-led format

one 12-week online support group led by a professional healthcare provider

moderated support

12-week online support in a peer-led format

peer-led

Paula Klemm, PhD

Purpose: The purpose of this project is to evaluate whether psychosocial outcomes in women with breast cancer differ based on the format of online group support. This objective will be addressed by the following specific aims:

1. Specific Aim #1 is to determine if there is a difference in depressive symptoms between women with breast cancer assigned to one of two treatment conditions: moderated online support or peer-led online support.

   • H1: Women with breast cancer who participate in moderated online support will report fewer depressive symptoms than women with breast cancer in peer led online support.
2. Specific Aim #2 is to determine if there is a difference in perceived social support between women with breast cancer who are assigned to one of two treatment conditions: moderated online support or peer-led online support.

   • H2: Women with breast cancer who participate in moderated online support will report greater perceived social support than women with breast cancer in peer-led online support.
3. Specific Aim #3 is to determine if there is a difference in quality of life in women with breast cancer who are assigned to one of two treatment conditions: moderated online support or peer-led online support.

   * H3: Women with breast cancer who participate in moderated online support will report better quality of life than women with breast cancer in peer-led online support.

NOTE: Once the study began, it was obvious that we could not prevent anyone from joining a support group, if that was her choice. We also could not control if participants joined a second online support group or face-to-face group during the study. Therefore, we decided to omit a "usual care" (no support) group. The study was completed with just two groups: moderated and peer-support.

Purpose/Specific Aims: The purpose of this randomized two-group longitudinal study is to evaluate whether psychosocial outcomes in women with breast cancer differ based on the format of online group support. Rationale/Significance of study: No research has explored differences in psychosocial outcomes between online support groups that use a professional moderator and those that use a peer-led (self-help) format. This study will address one of the goals put forth in the 2003-2005 ONS Research Agenda, by studying the effects of technology based interventions (online support) on psychosocial outcomes (depression, perceived social support, quality of life) in women with breast cancer. This work will add to the nursing research base with regard to online support for women with breast cancer and provide a springboard for additional studies to enhance the research base. Conceptual Framework: The concept of openness, based on the mutual interaction between human beings and their environment, and emphasized in Rogers' Science of Unitary Human Beings provides a basis for this project. The research will utilize two different support environments and measure how interactions in each affect psychosocial outcomes over time. Main Research Variables: The independent variables are two treatment conditions (moderated online support, peer-led online support). The dependent variables are depressive symptoms, perceived social support, and quality of life. Design: A randomized longitudinal design, comparing two types of online support groups, on the basis of three principal measures, will be used. Each measure will be obtained at baseline and at three later timepoints. Setting: Support groups will be accessed from secure and password protected university web pages devoted exclusively to this study. Sample: Sixty women with breast cancer, at least 21 years of age, who have Internet access will be recruited. Methods: Women will be randomly assigned to one of the two treatment conditions (moderated online support, peer-led online support) given a password, and instructed to complete a Demographic Form and the study questionnaires online. All subjects will be asked to complete the study questionnaires again at 6, 12, and 16 weeks. Moderated groups will run in a semi-structured format over 12 weeks, with a different discussion topic moderated each week by the moderator. Peer-led groups will be run in a peer support format over 12 weeks. Implications for practice: Women with breast cancer are turning to online resources for support. Nurses should be aware of the benefits/limitations of this support alternative. A cost benefit may be suggested if it is shown that peer-led online support has psychosocial benefits similar to professionally facilitated groups. Additional research is needed to explore the impact of online support on psychosocial outcomes in people with other cancers, minorities, and men. This study will add important information to the research base regarding online support groups and help determine the best strategy for online cancer support.

NOTE: It was obvious that we could not prevent anyone from joining a support group, if that was her choice. We also could not control if participants joined a second online support group or face-to-face group during the study. Therefore, we dropped the "usual care" (no support) group. The study was completed with just two groups: moderated and peer-support.

Psychosocial Outcomes in Online Cancer Support Groups

The Personal Resource Questionnaire 85 (PRQ85), Part II measures perceived social support and consists of 25 items in a seven-point Likert format which are rated from seven (7) strongly agree, to one (1) strongly disagree. Scores range from 25 to 175 with higher scores indicative of higher levels of perceived social support. Alpha reliability of the PRQ 85 has been demonstrated at \>.90

The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report scale widely used in the assessment of depression. Each item is given a rating of 0 to 3, with a potential range of 0 to 60 for the entire scale. Higher scores are associated with depression. The cutoff for the diagnosis of Major Depressive Disorder on the CES-D is 16. The instrument is a reliable measure (Alpha \>.85) of depression

The Rotterdam Symptom Checklist (RSCL) measures quality of life in cancer patients. The RSCL checklist includes a QOL life question on a scale of 1 (excellent) to 7 (extremely poor). This was used as a measure of overall QOL.

Christiana Care Health Services

Paula Klemm, PhD, RN, OCN

Moderated

Peer-led

Moderated Group

Non-facilitated (Peer-led)

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

One limitation was the lack of a control group of women who did not take part in an online or face-to-face support group. The reasons for this are explained above.

Power calculation indicated that 60 subjects would be needed. Null Hypothesis: There will be no difference in perceived social support based on type of online support group (moderated or peer-led).

Scores on the Personal Resource Questionnaire 85.

Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in depressive symptoms based on type of online support group (moderated or peer-led).

Scores on the CES-D Scale

Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in quality of life (QOL) based on type of online support group (moderated or peer-led).

Scores on the Quality of Life (QOL) Question on the Rotterdam Symptom Check List (RSCL).

Overall Study

Symptoms and General Pathology

Death

Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks.

Subjects in this arm will continue to receive standard care from their healthcare providers during the initial study period (i.e. no intervention). After four weeks, subjects will then participate in Reimagine's online Four Conversations program.

The online Four Conversations program consists of tutorial videos, printable documents, and live sessions with a counselor to educate subjects on shared decision making and care planning for those with advanced disease.

Four Conversations

Sophia K Smith, PhD

The purpose of this study is to see whether patients with metastatic breast cancer, their caregivers, and their healthcare providers can improve in shared decision making (SDM) and preparedness around end of life (EOL) planning through participation in Reimagine's online Four Conversations™ program. The goal is to close clinical practice gaps and enhance the quality of care for patients with metastatic breast cancer through increased competence and performance of healthcare providers and healthcare systems.

Four Conversations RCT

Four Conversations Randomized Controlled Trial

Clickstream data associated with viewing videos and other web content (e.g., social community) on the Reimagine website will be collected and analyzed through a web analytics software package. Session attendance will be collected by the Reimagine staff (specially trained counselors called Pillar Guides) and sent to the study team for analysis following each of the online meetings.

The Program Satisfaction \& Evaluation questionnaire was developed by the study team to assess perceived helpfulness of the program in terms of outcomes and patient-provider communication. Points are totaled and summed.

The Preparation for Decision Making Scale is a reliable and validated self-reported measure of the patient/caregiver or provider's perception of how useful a decision support intervention is in preparing the respondent to communicate with others making a health decision. Items are summed and scored, then divided by 10; scores can be converted to a 0-100 scale. Higher scores indicate higher perceived level of preparation for decision making.

The Decision Self-efficacy Scale is a reliable and validated instrument that measures self-confidence or belief in one's abilities in decision making, including shared decision making (SDM). Items are summed, divided by 11, and multiplied by 25. Scores range from 0 to 100 (very confident).

The Decisional Conflict scale is a reliable and validated measure of the state of uncertainty about a course of action. Items are summed, divided by 16, and multiplied by 25. Scores range from 0 to 100 (high decisional conflict).

The content of the City of Hope End of Life Knowledge Assessment was revised to reflect the program curriculum. Correctly answered questions will be awarded one point, summed, and a total score generated.

The PROMIS Global Scale is a reliable and validated measure of general perceptions of health. Items are predictive of care utilization and mortality. The scale produces two health scores: physical and mental. Items are summed and converted to t-scores.

The EOL Conversations are author-developed questionnaires incorporating items from the Survey on Advanced Care Planning Conversations. Points are totaled and summed.

Duke Cancer Institute

National Comprehensive Cancer Network

Pfizer

Pillars4Life, Inc.

Duke University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Exercise

Ralph Manders, PhD

Ralph J Manders, PhD

Currently, there are few opportunities for patients with cancer to have individual exercise guidance, and this has further been impacted by the Covid-19 pandemic. However, during the pandemic the use of virtual/remote platforms has been crucial in delivering care to cancer patients. The investigators think that remote exercise training may also offer a solution to support positive change in prostate cancer patients. As a result, the investigators have developed a remote/online exercise programme to explore this further.

This study will explore the effectiveness of an 8-week remote exercise and behavioural support intervention, and whether prostate cancer patients feel they benefit from this. The study also aims to see if this sort of exercise programme can be delivered to more prostate cancer patients in the future. This project is open to men with prostate cancer on long term hormone therapy. The intervention will be comprised of one remote supervised session per week, completed 1-1 using an online platform and up to two additional sessions, depending on its suitability for the patient, will be prescribed as unsupervised home-based exercise.

The Remote Study: Investigating the Effects or Online Exercise on Quality of Life in Men With Prostate Cancer

An Individualised 8-week Remote Exercise Intervention to Improve QoL, Cardiometabolic Risk and Physical Activity Level in Men With Prostate Cancer Undergoing ADT Treatment.

No de-identified data will be shared with other researchers to protect patient confidentiality

Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.

Functional Assessment of Cancer Therapy fatigue (FACIT-f) questionnaire. The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). It has been used frequently in the clinical trial setting (please see appendix 1). Responses to each question are added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.

Godin Leisure Time Exercise Questionnaire. This is a 3 question self-report questionnaire - indirect measure of physical activity

The Dukes Activity Status Index. The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs).

Qrisk3. Estimation of cardiovascular risk based on demographical and physiological parameters

Session adherence. The number of sessions attended, and % of scheduled sessions performed. Every exercise session either completed or not completed over the 8 week intervention period

eq-5d-5l. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, some problems, severe problems and unable to do. Each level of answer consists of each level of score ranges from 1 to 5. Each participant will have a health status consisting of 5 digits. Using the set of weights from Vietnamese population provided from the EuroGroup, we can convert each EQ-5D health state into a single summary index value. The index value ranges from 0 to 1, higher scores meaning better health quality.

Royal Surrey County Hospital NHS Foundation Trust

University of Surrey

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Anxiety Disorders

Depression

Depressive Disorder

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Staci M Peron, Ph.D.

Background:

- Studies show that Internet Support Groups (ISGs) can help parents of children with chronic conditions. Researchers want to find out if ISGs can help parents of a child with the genetic disorder Neurofibromatosis Type 1 (NF1).

Objective:

- To see if an ISG for parents with a child with NF1 can give the parents more social support and less anxiety.

Eligibility:

- Adults age 18 and older with a child (age 0 25 years) with NF1.

Design:

* Participants will register for the study on a website hosted by the Children s Tumor Foundation.
* Participants will complete 5 questionnaires. These will be about their emotional well-being, their child s health status, and their contact information.
* The ISG will include a Discussion Forum that participants can enter 24 hours a day, 7 days a week. A professional moderator will post questions and discussion topics. The moderator can also respond to questions. They will be a psychologist, a psychology associate, or a nurse-practitioner. Each one will be highly experienced at working with young people with NF1 and their families.
* The ISG also will contain a chat room. Here participants can chat with other users in real time. The chat room will be open for one 90-minute session per week.
* The ISG will remain open for 8 weeks. Then participants will retake 4 of the questionnaires from the beginning of the study. They will also complete 1 other questionnaire about their experiences with the ISG. Information from any messages participants post on the ISG website will be collected.
* Three months after the ISG closes, participants will complete the questionnaires one final time.

BACKGROUND:

* The complex symptom profile in NF1 puts children and adolescents with this condition at risk for a variety of physical, cognitive, and social-emotional difficulties. Thus, caring for a child with a chronic medical condition such as NF1 can be challenging.
* Over the last two decades, researchers have been examining the use of internet support groups (ISGs) as a means of connecting individuals with similar conditions, diagnoses, or challenges to provide emotional and informational support.
* While the benefits of ISGs have been well documented in many studies of medical patients, very few have examined the use of ISGs in parents of children with chronic medical conditions. Further, no studies have been conducted on an ISG in parents of a child with NF1.

OBJECTIVES:

* The primary objective of this pilot study is to assess the effectiveness of an ISG designed for parents of children with NF1 on a measure of perceived social support.
* Secondary objectives are to assess effects of the ISG on self-efficacy, depression, and anxiety, and to explore themes and topics discussed in the ISG.

ELIGIBILITY:

Eligible participants must self-report:

* Being greater than or equal to 18 years of age
* Having a child with a diagnosis of NF1 between 0 and 25 years of age
* Living in the same home as the child with NF1

  * Having regular access to a computer with internet capability

DESIGN:

* Parents of children with NF1 will be recruited through Dr. Widemann s NF1 patient database and through the Children s Tumor Foundation s (CTF) NF registry.
* Eligible participants will be emailed a link to access the study website through the CTF website. Due to the nature of the study, consent will be obtained online.
* After consenting, participants will be administered (electronically) baseline measures of perceived social support, self-efficacy, depression, and anxiety. After 8 weeks, participants will complete the measures again via the same website, as well as a post-study questionnaire assessing their experiences with participation. Measures will be repeated at 3-months post-intervention.
* Content analyses will be performed to identify themes and needs of the participants

Internet Support Group for Parents of a Child With Neurofibromatosis Type 1

Effects of an Internet Support Group for Parents of a Child With Neurofibromatosis Type 1

To determine the effects of an ISG on perceived social support among parents of a child with NF1 from baseline to 8 weeks and frombaseline to 3 months postintervention.

To determine the effects of an ISG on perceived social support among parents of a child with NF1 from baseline to 8 weeks and frombaseline to 3 months post-intervention.

National Cancer Institute (NCI)

Those in the immediate intervention arm will begin the LovingKindess Meditation practice upon enrollment.

Those in the deferred intervention arm will commence the LovingKindness Meditation practice intervention approximately 3 weeks (post 3 -week survey) after enrollment and participate three weeks thereafter.

Participants will have access to a recording of a script to guide them through meditation

LovingKindess Meditation

Mary Jo Kreitzer, PhD, RN, FAAN

CaringBridge (CB) is an online health community for people undergoing challenging health journeys. This platform provides an opportunity for individuals and their caregivers to rally support for a loved-one during a health journey. CaringBridge offers the opportunity for expressive writing through journal entries, wellbeing resources, participant health journey stories, and practical scheduling and communication tools to support community, healing, and wellbeing. Loving Kindness Meditation (LKM) is a systemized mind-body approach developed to increase loving acceptance and has been shown to increase resilience in the face of adversity. The aim of this study is to better understand how mind-body practices, like LKM, impact adult CB users

Implementation of Mind-Body Practices in an Online Community of Caring (CaringBridge)

The Perceived Stress Scale is a 10-item scale for measuring one's perception of stress. All 10 items are assessed by asking how often a respondent felt a certain way on a 5-point Likert measure (0 = Never; 4 = Very Often), with a minimum score of 0 and a maximum score of 40. Higher total scores indicate greater perceived stress.

This will be assessed at baseline and week three, in addition to week six for the deferred arm.

The Self-Compassion Scale (SCS) is a 12-item, shortened version of the original longer 26-item self-compassion scale (range 12-60). The 12-item SCS contains the same higher-order factor structure as the 26-item scale with a general Higher-Order Self-Compassion factor and six second-order factors of Self-Kindness, Self-Judgement, Common Humanity, Isolation, Mindfulness, and Over-Identification. All 12 items are assessed by asking how often a respondent felt a certain way on a 5-point Likert measure (1 =Almost never; 5 =Almost always). Higher SCS scores are associated with psychological well-being and suggest self-compassion might be an important protective factor, fostering emotional resilience.

This will be assessed at baseline and week three, in addition to week six for the deferred arm.

The Compassionate Love Scale (CLS) is a 21-item measure of the stranger-humanity version of the original CLS designed to measure compassionate love for humanity (range 38-147). Higher CLS scores indicate greater compassionate love for humanity.

This will be assessed at baseline and week three, in addition to week six for the deferred arm.

Social connectedness is assessed with 8 items on a 6-point Likert scale (1 = strongly agree through 6 = strongly disagree), with a total range of 8-48. Social connectedness is reverse coded such that high scores indicate higher social connection.

This will be assessed at baseline and week three, in addition to week six for the deferred arm.

Social assurance is assessed with 8 items on a 6-point Likert scale (1 = strongly agree through 6 = strongly disagree), with a total range of 8-48. Social Assurance is reverse coded such that high scores indicate higher social assurance. This will be assessed at baseline and week three, in addition to week six for the deferred arm.

University of Minnesota

Wait-list Control Group. The control group will receive the next available online MBSR program.

Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program.

Immediate MBSR

Wait-list Control Group.

Linda Carlson, PhD

For people with cancer, in-person Mindfulness-Based Stress Reduction (MBSR) participation can decrease stress symptoms, mood disturbance, and fatigue, as well as enhance personal growth and spirituality, and improve quality of life and sleep. Online MBSR may improve the accessibility of MBSR programs to underserved cancer patients who are unable to attend available in-person groups. This study will examine whether patients are willing to participate and complete the program, and also whether the online program improves mood and stress.

The eCALM Study - An Online Mindfulness-Based Stress Reduction Program for Individuals Living With Cancer in Alberta

The eCALM Study - eTherapy for Cancer Applying Mindfulness: Online Mindfulness-Based Stress Reduction Program for Underserved Cancer Patients in Alberta: A Randomized Wait-list Controlled Trial.

recruitment, retention, attendance, adherence, satisfaction

Profile of Mood States (POMS), Calgary Symptoms of Stress Inventory (C-SOSI)

Tom Baker Cancer Centre

Alberta Health services

care as usual (fertility preservation counseling)

Intervention: use of an online decision-aid tool after fertility preservation counseling

Online Decision-Aid Tool

Sibil Tschudin, PD Dr. med.

Women who are diagnosed with cancer during their reproductive lifespan might be confronted with impaired fertility. Nowadays a number of fertility preservation options are available. Decisions about whether and how to protect fertility have to be made in a very short time period, right after cancer diagnosis and before start of treatment. The psychological impact for patients is considerable. This project aims at developing a standardized decision-aid tool to support the decision-making process about fertility preservation in young cancer patients. It is designed as an online decision-aid tool. A web-based tool is perfectly designed for this target group and offers new possibilities providing flexible and individually tailored information.

The aim of the study is to examine the benefits of the online decision-aid tool compared with standard counseling (usual care). Decisional conflict is measured immediately after counseling as well as one month later. One year after counseling, decisional regret is being evaluated additionally. If the decision-aid tool proves to be helpful and useful, the online design allows making it available for a wide range of concerned patients.

Background: Impaired fertility is often a consequence of successful cancer treatment and fertility preservation (FP) is nowadays an option for young cancer survivors. Decisions on FP, however, have to be made in the short time period after cancer diagnosis and before onset of treatment. According to previous studies the availability of helpful information is still low, decisional conflict substantial and decisions-aids would be highly desirable.

Objectives: The project aims at introducing the knowledge gained by the previous research into the development of a standardized online decision aid (DA) that complements and supports shared decision-making in fertility issues and FP for young cancer patients and their medical caretakers and to evaluate the efficacy of this DA compared with usual care. Primary objective: To show that an online decision-aid tool in addition to standard counselling reduces decisional conflict compared to standard counselling alone. Secondary objectives: 1) to assess whether the decision-aid tool decreases decisional regret significantly, 2) to assess whether the use of the decision-aid tool increases the patients' knowledge on FP and 3) to assess whether patients estimate the decision-aid tool helpful in facilitating the decision-making process.

Methods: Design: Prospective, consecutive interventional study comparing a control group with standard counselling (phase 1) with an interventional group with counselling and application of the DA (phase 2). After completing phase 1 and 2 with a sample of 40 participants, we change the study design into a randomized controlled trial and randomize 88 participants in this part of the study. Sample: A total of 120 young cancer patients followed at one of the collaborating Swiss or German cancer centers aged 16 to 40 years who are possible candidates for FP . Intervention: Online DA, which is developed based on the applicants' research findings and on a prospectively evaluated fertility-related Australian decision aid booklet. Measures: Decisional Conflict Scale (DCS); items on knowledge, attitude and willingness concerning FP; decision regret scale (DRS); items on satisfaction and helpfulness of the DA.

Procedures: The control and the interventions group completes the questionnaires at three time points, i.e. immediately after the counselling (T1), after 1 month (T2) and after 12 months (T3).

Analysis and statistics: The difference in decisional conflict between the two groups will be analyzed by using a one-way analysis of variance (ANOVA) and a propensity score weighted ANOVA to adjust for confounding variables.

Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation

Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation - Effects of an Online Decision-aid Tool

with a questionnaire which assess the knowledge about various fertility preservation methods

questionnaire to assess helpfulness and satisfaction of tool only for the intervention group, who used the decision-aid tool

Swiss Bridge

University Hospital, Basel, Switzerland

Frailty

Mackenzi Pergolotti, PhD

Pilot feasibility study of the ReVital Chemotherapy Online Resiliency Evaluation (CORE) program. As part of standard of care, patients starting a new chemotherapy regimen are referred to complete a pre-chemotherapy cancer rehabilitation evaluation (i.e., prehab) and invited to enroll in the ReVital-CORE program study.

Once enrolled in ReVital-CORE, participants will complete a monthly online evaluation for 1 year. If frailty (or pre-frailty) is detected on any survey, physical or occupational therapy will be initiated for standard of care rehabilitation evaluation and treatment.

All patients starting a new chemotherapy regimen will be referred to completed a prehab evaluation with a specialized physical or occupational therapist be and invited to enroll in the ReVital-CORE program for the pilot, feasibility study.

Participants in the ReVital-CORE program study will be emailed an online evaluation each month via for one year. Once completed, the evaluation is automatically scored into: frail, pre-frail or robust categories using a validated frailty index. Any patient categorized as frail or pre-frail will be re-referred to rehabilitation by their cancer care team. For frail and pre-frail individuals, standard of care rehabilitation therapy will include either/and occupational and physical therapy evaluation and treatment and will be billed via their insurance.

The purpose of this pilot study is to evaluate feasibility of the of the ReVital-CORE Program for individuals starting a new chemotherapy regimen. Secondary aims are to evaluate the prevalence, trajectory and predictors of frailty during the first year of chemotherapy treatment; and evaluate the impacts of prehab/rehabilitation for participants identified as frail and pre-frail.

ReVital-CORE Program

ReVital Chemotherapy Online Resiliency Evaluation (ReVital-CORE) Program Pilot Feasibility Study

IPD will not be shared with other researchers.

Proportion of patients who consent to enroll, out of the total number invited.

Proportion of participants at all major timepoints (pre-chemo, and monthly following start of chemo for 12 months) who are identified as frail or pre-frail by a patient-reported frailty index.

Change from baseline to discharge in quality of life as measured by the Patient Reported Outcomes Measuring System (PROMIS)-global 10-item questionnaire.

Change from baseline to discharge in frailty as measured by a patient-reported frailty index.

Select Medical

Kessler Foundation

Senior Director, Research and Clinical Development

Participants will engage in 12, weekly, supervised, exercise sessions using Zoom with the exercise trainer. Once a week, the exercise trainer and participant will each log on to Zoom from their locations to begin the supervised exercise session. The exercise trainer will record all sessions. Sessions will be 30 to 45 minutes long and be structured as follows: review of previous session and an opportunity to ask questions; 5-minute warm-up; 20- to 25-minute workout; 5- to10-minute cool down and reminder of next session and/or data collection time period. Supervised sessions will be scheduled once a week over the 12-week intervention. Participants will be expected to complete their resistance-based physical activity program for an additional 1-2 days a week as per the intervention schedule to meet as physical activity guidelines. The exercise trainer will track participant attendance. During the session, participants must have another person in the same location in case of an emergency.

The attention control arm will include a printed, individualized resistance-based physical activity program.

Participants randomized to the control arm will be given a printed or digital individualized, resistance-based physical activity program and told to aim to for three exercise sessions per week. Control participants will follow the same measurement schedule as intervention participants.

Participants randomized to the intervention arm will engage in 12, weekly, supervised, exercise sessions using Zoom with the exercise trainer.

Online-delivered physical activity intervention.

Without the supervision of an exercise trainer, participants will be given a printed, individualized resistance-based physical activity program to complete over the course of 12 weeks.

Printed, individualized resistance-based physical activity program.

Angela Fong, PhD

The goal of the study is to test the feasibility and acceptability of a supervised, online-delivered, individualized, physical activity program in a sample of post-active treatment breast cancer survivors. The proposed intervention will use a 2-arm randomized controlled trial study design to compare a 12-week resistance-based physical activity program to an attention control (i.e., printed individualized physical activity program) group on feasibility, acceptability and changes in strength as measured by 10 repetition maximum (10RM). Both groups will wear accelerometers. The main hypothesis is that participants randomized to the intervention arm will rate the online-delivered physical activity program as feasible and acceptable compared to attention control participants. The overall rationale is that delivering a physical activity intervention online may increase uptake of the intervention, which may lead to maintained physical activity behavior and associated health benefits. The primary outcomes are feasibility as measured by participant retention and acceptability as measured by adherence to physical activity program (recorded by physical activity log). Secondary outcomes include changes in strength as measured by 10RM, objectively measured physical activity levels as measured by the accelerometer, satisfaction, physical functioning and health-related quality of life. Additionally, a select number of participants will be invited for an interview to talk about their experiences in the program, motivation and barriers to exercise.

Interview description: Participants will complete one-on-one interviews with the PI or research staff over videoconferencing software (Rutgers Zoom). The interview will be 45 to 60 minutes in duration and audio recorded using the "record meeting" function. Prior to the interview, participants will consent to being audio recorded. The recording will be stored on Box (a HIPAA compliant cloud drive). A transcript of the audio will be generated using the "audio transcript" function on Rutgers Zoom and transcribed by a third party to ensure accuracy.

The project will use a 2-arm randomized controlled trial study. The intervention will include a 12, weekly, supervised, online-delivered, individualized resistance-based exercise program. The attention control arm will include a printed, individualized resistance-based physical activity program. A total of 50 breast cancer survivors will be recruited from Rutgers Cancer Institute of New Jersey (CINJ) and randomized to one of two study arms. The intervention arm will test the feasibility and acceptability of the intervention compared to the control arm, which will receive a printed or digital copy of an individualized physical activity program. Participants from both arms will receive an accelerometer (ActiGraph GT3X+), resistance bands (TheraBand®), and additional free weights (if required). Outcome measures will be assessed at baseline (pre-intervention), Week 12 (post-intervention) and Week 24 (follow-up). Data collection will occur both in-person and online. Data will be both objective (10RM, functional strength, physical activity measured by accelerometers, physical function assessments, and attendance) and subjective (self-reported physical activity program adherence, satisfaction, physical activity levels, health-related quality of life, and exercise and barrier self-efficacy).

Additionally, participants will complete one-on-one interviews with the PI or research staff over videoconferencing software (Rutgers Zoom). The interview will be 45 to 60 minutes in duration and participants will be asked to discuss their experiences in the program.

Breast Cancer and Resistance Exercise Program

Breast Cancer and Resistance Exercise Program (B-REP): A Feasibility and Acceptability Trial

Individual data that underlie results will be shared after de-identification for analysis purposes. Data sources include: 1) clinical and physical assessment data collected at the CINJ, 2) patient-reported questionnaire data collected through REDCap in a personal device or study-specific iPad, 3) observational data collected from recording one-on-one exercise sessions, and 4) Interview audio from zoom and transcribed interviews

The final dataset will not contain any information that could identify individuals. Data will be shared using secure, Rutgers email between the PI and Co-Is.

Participant retention at assessment timepoints (attendance and completing assessments)

Adherence to physical activity program/intervention (attendance and exercise logs)

Satisfaction will be measured as participants' experience and perceptions of an internet intervention. Scale values: Not at all, slightly, somewhat, mostly \& very. Higher scores are associated with a greater level of satisfaction.

Changes in strength measured by 10RM assessment

Self-report exercise frequency (times per week) and intensity (mild, moderate, and vigorous). Higher scores indicate that individuals are more active.

Objective measure of total physical activity levels with intensity and duration (minutes). No scale.

Functional assessments including senior fitness test, which includes the 6 minute walk test, chair sit to stand test and arm curl test. Scores are compared to age-matched, national averages.

Confidence to exercise over the next three months rated on a scale of 0% to 100% confidence. High scores indicate higher perceived confidence to exercise.

Confidence to overcome commonly-reported barriers rated on a scale of 0% to 100%. Higher scores indicated higher perceived confidence to overcome barriers.

Scale measures physical wellbeing, social/family wellbeing, emotional wellbeing and functional wellbeing with items specifically for breast cancer (additional concerns). Scale - Not at all, a little bit, some-what, quite a bit, very much. Higher scores indicate better outcomes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Psychosocial Outcomes in Online Cancer Support Groups	NCT00382785	Breast Cancer	moderated suppo... peer-led	21 Years -	Christiana Care Health Services
Four Conversations RCT	NCT02944344	Breast Cancer	Four Conversati...	18 Years -	Duke University
The Remote Study: Investigating the Effects or Online Exercise on Quality of Life in Men With Prostate Cancer	NCT05989854	Prostate Cancer	Exercise	18 Years - 99 Years	University of Surrey
Internet Support Group for Parents of a Child With Neurofibromatosis Type 1	NCT02153931	Neurofibromatos...		18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Implementation of Mind-Body Practices in an Online Community of Caring (CaringBridge)	NCT05002842	Cancer Stress	LovingKindess M...	18 Years -	University of Minnesota
The eCALM Study - An Online Mindfulness-Based Stress Reduction Program for Individuals Living With Cancer in Alberta	NCT01476891	Mindfulness-Bas... Cancer	Immediate MBSR Wait-list Contr...	18 Years -	AHS Cancer Control Alberta
Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation	NCT02404883	Cancer	Online Decision...	16 Years - 40 Years	University Hospital, Basel, Switzerland
ReVital-CORE Program	NCT04852575	Frailty Cancer Chemotherapy-In...		18 Years -	Kessler Foundation
Breast Cancer and Resistance Exercise Program	NCT04562233	Breast Cancer Resistance Trai...	Online-delivere... Printed, indivi...	18 Years -	Rutgers, The State University of New Jersey
Gynaecology Exercise and Mindfulness Study	NCT05561413	Gynecologic Can... Uterus Cancer Ovary Cancer Cervical Cancer Vaginal Cancer Vulvar Cancer	Mindfulness and... Mindfulness	18 Years -	University of Ulster
Four Conversations RCT	NCT02944344	Breast Cancer	Four Conversati...	18 Years -	Duke University
Breast Cancer and Resistance Exercise Program	NCT04562233	Breast Cancer Resistance Trai...	Online-delivere... Printed, indivi...	18 Years -	Rutgers, The State University of New Jersey
Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation	NCT02404883	Cancer	Online Decision...	16 Years - 40 Years	University Hospital, Basel, Switzerland
Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer	NCT01142102	Bladder Cancer	Radiation Thera...	18 Years -	Trans Tasman Radiation Oncology Group
Implementation of Mind-Body Practices in an Online Community of Caring (CaringBridge)	NCT05002842	Cancer Stress	LovingKindess M...	18 Years -	University of Minnesota

Spots Global Cancer Trial Database for online

Every month we try and update this database with for online cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for online

Every month we try and update this database with for online cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for online cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.