Behaviors and Mental Disorders

All Conditions

Financial Stress

Stress, Psychological

Behavioral Symptoms

Participants in this arm will receive their usual care plus a Financial Resource Sheet. The financial resource sheet lists and describes existing organization and community resources available to KP members.

Participants in this arm will receive their usual care, and the Financial Resource Sheet described in Arm 1, plus one (1) cycle of financial navigation (total cycles: 1; total length: 6 months). In each intervention cycle participants will get at least one (1) phone call with a CAFÉ Financial Navigator, the navigator will talk with participants to identify financial questions or concerns. The navigator will create a personalized plan for each participant. Participants can request extra support from the navigator for up to 6 months.

Participants in this arm will receive their usual care, a Financial Resource Sheet and the brief intervention described in Arm 2 (i.e., one (1) cycle of financial navigation). Plus, they will receive two (2) additional cycles of financial navigation (total cycles: 3; total length: 6 months).

The CAFÉ intervention is a financial navigation intervention. During the Intervention, a CAFÉ financial navigator will provide information support and resources to people with cancer after diagnosis. CAFÉ intervention components include: (1) proactive assessment of patient financial questions and concerns (e.g., acute financial need or inability to pay for household expenses; deciding between care options depending on cost; uncertainty around planning for out of pocket costs and/or when patients will need to pay), (2) proactive, personalized support and referrals.

Financial navigation

The financial resource sheet lists and describes existing internal and community resources available to KP members

Enhanced usual care

Nora B Henrikson, PhD, MPH

Matthew Banegas, PhD, MPH, MS

Amanda Petrik, PhDC, MS

This study is a randomized clinical trial designed to test a novel financial navigation intervention. The study assesses the impact of the financial navigation intervention on financial hardship and health-related quality of life, cancer-related material and psychological financial hardship, patient-centered communication, and time to initiation of treatment.

Rationale:

Up to half of people with cancer experience financial hardship. Cancer-related financial hardship is associated with several adverse intermediate and health outcomes, including poor quality of life, treatment non-adherence, and lower survival.

Observational evidence suggests that communication about financial concerns and out-of-pocket (OOP) costs early in the treatment trajectory and in partnership with the care team could help to prevent or lessen financial hardship. This type of communication could be delivered through patient navigation programs and is consistent with both patient and care team preferences.

However, to date there is no evidence from randomized trials showing the impact of financial navigation during the active treatment on financial hardship. Further, no intervention-based studies have provided evidence on the most effective ways to mitigate cancer-related financial hardship.

Background:

As costs of cancer care in U.S. have risen over time, so has the burden of out-of-pocket (OOP) costs and indirect costs such as travel, employment changes, and caregiver costs. These cumulative costs pose increased financial risk for people diagnosed with cancer. Despite a patient's health insurance status, financial hardship from cancer care is prevalent: 47%-49% of cancer survivors report financial hardship and 12%-62% of cancer survivors report debt due to treatment costs. Financial hardship is associated with decreased treatment initiation and adherence, poor symptoms and quality of life, and increased mortality risk, so preventing or mitigating its effects is a clinical imperative.

Integration of cost of cancer care information into conversations between patients and clinicians can optimize medical decision-making and reduce the risk of financial hardship, and is consistent with high-quality cancer care and patient preferences. Patient understanding of OOP costs can assist with planning and budgeting, and can facilitate early connection with financial support services that may help to mitigate the financial burden of cancer care. Yet, less than one in five patients report having cost discussions. Consequently, many patients are uninformed about the costs of their cancer care and face unexpected OOP costs, with important consequences for material (e.g., debt), psychological (e.g., cost-related distress), and behavioral (e.g. treatment adherence) financial hardship.

There is an urgent need for evidence-based interventions on how to prevent or mitigate financial hardship for people with cancer. While the extent of financial hardship as a toxicity of cancer care is increasingly well-documented, there is limited evidence to date as to what types of interventions can mitigate or prevent financial hardship due to cancer care. Policy, societal, and organizational-level interventions, such as those focused on bending the curve of rising health care cost or improving price transparency to ordering providers are all needed, but these may take a long time or show limited effect. In the meantime, patients continue to need assistance navigating, managing and anticipating OOP costs, and patient- and team level-interventions such as the CAFÉ study may hold promise for this purpose.

Cancer Financial Experience

CAFÉ: Clinic Based Intervention to Address Financial Hardship for People With Cancer

Proportion of patients initiating treatment, including radiation, surgery, and systemic therapy.

Defined as the number of days between: 1) date of diagnosis/recurrence and start of first-line treatment. Censoring events will include disenrollment, death, and end of the study, whichever comes first.

Proportion of participants who enrolled in the Kaiser Permanente MFA program within 12 months following baseline

Proportion of participants whose medical billing account is administratively marked as past due within 12 months following baseline

Average OOP expenditures per patient between baseline and 12 months following baseline

16-item instrument intended to assess patient perspective on communication over the course of cancer care. The survey items are conceptually grounded in the 6 functions of patient-centered communication: fostering healing relationships, effectively exchanging information, responding to emotions, making quality decisions, managing uncertainty, and enabling patient self-care.

InCharge Financial Distress/Financial Well-Being Scale. This is a validated, 8-item scale that assesses current ability to meet financial obligations, stress or worry about finances, and satisfaction with present financial situation. It is scored to a 10-point scale, where 1 is "Overwhelming financial distress/lowest financial well-being," and 10 is "No financial distress/highest financial well-being." It has been validated in multiple populations and national norms are provided.

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

Items from the Medical Expenditure Panel Survey (Yabroff 2016):

Material financial hardship items:

Have you or has anyone in your family had to borrow money or go into debt because of your cancer, its treatment or the lasting effects of that treatment? (Yes\\No)

Did you or your family ever file for bankruptcy because of your cancer, its treatment, or the lasting effects of that treatment? (Yes\\No)

Have you or your family had to make any other kinds of financial sacrifices because of your cancer, its treatment, or the lasting effects of that treatment? (Yes\\No)

Please think about medical care visits for cancer, its treatment, or the lasting effects of that treatment. Have you ever been unable to cover your share of those visits? (Yes\\No)

Psychological financial hardship item:

Have you ever worried about having to pay large medical bills related to your cancer? (Yes\\No)

Kaiser Permanente

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.

Participants use an activity monitor and the interactive website.

In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.

Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.

Activity Monitor

Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.

Interactive Website

All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.

Educational Materials

Kirsten K. Ness, PT, PhD

Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important concern. The growing population of survivors is at an increased risk of physical inactivity and associated adverse health outcomes. Regular physical activity is associated with better cardiovascular and musculoskeletal health. Despite the known benefits of physical activity, nearly half of all childhood cancer survivors do not meet recommended guidelines for physical activity.

Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a rewards-based physical activity intervention delivered via an interactive website among young adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical activity levels and improve cardiovascular and musculoskeletal health. The investigators also want to learn if this rewards-based intervention is effective. To achieve this goal the investigators have designed a three-arm prospective, randomized study with two reward-based intervention groups and a control group.

PRIMARY OBJECTIVE:

* To compare changes in levels of moderate and vigorous physical activity over 24 weeks.

SECONDARY OBJECTIVE:

* To compare changes in cardiorespiratory fitness, muscular strength and flexibility over 24 weeks.

Participants will be randomized to one of three groups. Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. Participants randomized to the two intervention groups will be given access to a rewards program delivered via an interactive website, an activity monitor, and educational materials. Individual physical activity data can be viewed by study participants after uploading information from their monitors to the interactive website. One intervention group will receive minimal rewards, while the other group will receive immediate incentives as well as the minimal rewards as they move from one level to the other on the website.

After 24 weeks, changes in cardiorespiratory fitness, muscular strength, flexibility, and physical function will be compared between the two intervention groups and the control group.

A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.

The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.

The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups

The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.

The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.

The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.

The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.

The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.

The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.

The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups

The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.

The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups.

St. Jude Children's Research Hospital

Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.

Activity Monitor: Measurement of physical activity.

Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.

Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.

Group A: Minimal Rewards

Participants use an activity monitor and the interactive website.

In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.

Activity Monitor: Measurement of physical activity.

Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.

Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.

Group B: Immediate Incentives

Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.

Activity Monitor: Measurement of physical activity.

Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.

Group C: Control

Total

Age, Continuous

Age at diagnosis

Time since diagnosis

Age, Customized

Sex: Female, Male

Non-White

White

Race/Ethnicity, Customized

Leukemia

Central Nervous System Tumor

Lymphoma

Retinoblastoma

Other Solid Tumor

Diagnosis

Daily Moderate to Vigorous Physical Activity (MVPA)

Body mass index (BMI)

Resting heart rate (HR)

Resting respiratory rate (RR)

Systolic

Diastolic

Blood pressure (BP)

Peak VO2 is a measure of exercise capacity: volume of oxygen uptake per minute adjusted for weight.

Peak VO2

Sit and reach is a measure of low back and hamstring flexibility.

Sit and reach

Active dorsiflexion is a measure of ankle flexibility.

Active dorsiflexion

Hand grip is a measure of how much muscle power a person can generate gripping an object.

Hand grip

This measure assessed the number of sit-ups done in 30 seconds.

Sit-up

This measure assessed the number of push-ups done in 30 seconds.

Pushup

at 60 degrees/second

at 120 degrees/second

at 180 degrees/second

Quadriceps

at 30 degrees/second

Dorsiflexion

Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups

Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks

Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach

Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion

Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip

Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up

Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup

Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second

Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second

Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second

Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second

Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second

Overall Study

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Quality of Life

Patients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home.

Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.

Association of day hospitalization with hospital-at-home

Day hospitalization exclusively

Bénédicte MITTAINE-MARZAC, PharmD

Matthieu de STAMPA, MD

The study aims to compare the overall survival adjusted to quality of life of 2 groups of patients with multiple myeloma, depending on the type of care: (1) day hospitalization exclusively or (2) day hospitalization combined with hospital-at-home.

As secondary objectives, the study aims to compare the impacts of the two types of care organization on:

* the survival of patients and response to treatments according to criteria of the International Myeloma Working Group,
* psychological status of patients,
* specific toxicity related to treatment used (haematological and infectious toxicity, neurotoxicity, ...),
* health outcomes,
* the caregiver's burden,

This study is combined with a qualitative study about the incentives and the barriers, and in order to set up the patient's typology.

Multiple myeloma, a malignant blood disease with about 5000 new cases diagnosed annually in France, essentially in the elderly population, is associated with alteration of quality of life resulting from pathology and therapies.

Multiples cycles of chemotherapies are administered in a regular manner, as outpatient treatment or day hospitalization.

In this study aiming to explore the impacts on health outcomes and resources utilization of hospital-at-home for elderly patients with multiple myeloma, all patients will be treated by 4 standardized protocols of treatment including bortezomib by subcutaneous administration.

9 centers will participate to the study. The study will not change the usual practices of care of these centers:

* 6 centers organize patient care through day hospitalization combined with hospital-at-home,
* 3 other centers rely exclusively on day hospitalization.

The study will target overall the inclusion of 300 patients for the 9 centers and 70 participants (35 for each arm: 10 patients, 10 caregivers, 15 from healthcare team) for the qualitative study.

The individual follow up of each patient will last 12 months. The patient's vital status will be documented at the 24th month.

Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma

Comparison of quality of life using questionnaires EORTC QLQ-30.

Comparison of quality of life using questionnaires EORTC QLQ-MY20.

All patients will be evaluated in order to collect the following data:

* death and causality with multiple myeloma, treatments;
* progression or relapse according to criteria of International Myeloma Working Group;
* survival without progression, full or partial remission.

RAI-HC (Resident Assessment Instrument Home Care) will be used at home. Multidimensional evaluation involves 19 areas such as sociodemographic, environmental and clinical endpoints with psychological status, cognitive status, morbidity and medication compliance defined by validated synthetic clinical scales.

This evaluation will be performed for all patients with the National Cancer Institute Common Terminology Criteria for Adverse Events (CRCAE version 3.0).

Family quality of life will be evaluated with Zarit Burden Inventory

The following costs will be collected: hospitalization, home care, transport, biological exams, costs of chemotherapy (bortezomib) as well as indirect costs such as paid sick leave and salary of caregiver at home.

The assessment criteria are the quality care, the continuity of care, the coordination between the care actors, the information transmission, the incentives and the barriers according to the forms of hospitalization.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancer Financial Experience	NCT05018000	Cancer	Financial navig... Enhanced usual ...	18 Years -	Kaiser Permanente
A Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer	NCT01778127	Cancer	Activity Monito... Interactive Web... Educational Mat...	11 Years - 14 Years	St. Jude Children's Research Hospital
Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma	NCT03490084	Multiple Myelom...	Association of ... Day hospitaliza...	65 Years -	Assistance Publique - Hôpitaux de Paris
EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality	NCT03987633	Atrial Fibrilla... Coronary Heart ... Cardiovascular ... Heart Failure Hypertension Peripheral Arte... Stroke, Ischemi... Asthma Chronic Obstruc... Obesity Cancer Chronic Kidney ... Diabetes Mellit... Dementia Depression Epilepsy Mental Health D... Rheumatoid Arth... Blood Pressure		6 Years -	Future Genetics Limited

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