Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data.

Digital health intervention consisting of weekly calls from a Health Advisor to a participant, accompanied by delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.

Digital Health Coaching Program

A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.

Fitbit

Kelly Brassil, PhD

Jennifer Loftis, DNP

Trenton Grossfeld

Rahul Banerjee, MD

This study will evaluate the feasibility of a digital health coaching program for adults with relapsed or refractory multiple myeloma (R/R MM). One hundred adults with R/R MM will be enrolled at The University of Washington. Individuals who agree to take part in the study and sign an informed consent will be enrolled in a 3-month digital health coaching program. The program will provide weekly phone calls plus the delivery of learning materials to text or email. Questionnaires and data from a wrist-worn activity tracker will be collected. Outcomes include treatment and symptom experience, quality of life, financial burden, and how confident people feel to manage their health. Information about your condition and treatment will be collected, along with how often you use services like the emergency room, for care. This data will provide a better understanding of how a person experiences their R/R MM.

Multiple myeloma (MM) is a chronic malignancy with no current cure. Previously dependent on myeloablative chemotherapy and stem cell transplantation to induce prolonged remission, recent advances in targeted therapies are enhancing overall survival and extending the duration between treatments. Monoclonal antibodies, including CD38-directed monoclonal antibodies, combination immunotherapies, and T-cell therapies are among the many promising agents for treating relapsed or refractory (R/R) MM. This improvement in treatment outcomes is accompanied by significant risk for toxicities such a neutropenia and subsequent infections which themselves can be life-threatening. Several studies indicate a high symptom burden and poor health-related quality of life for individuals with multiple myeloma, with most of what is known from clinical trials of highly selective populations or qualitative studies conducted outside of the US among mostly white patients. These factors, coupled with the rapidly changing multiple myeloma treatment landscape, limits the generalizability to wider population as well as an understanding of MM's impact across the disease course. A more complete investigation of the symptom burden, health self-efficacy, and financial, physiologic, and psychosocial well-being among patients with multiple myeloma is urgently needed to provide a comprehensive view of the ways in which multiple myeloma and its treatments affects individuals' lives.

The purpose of this study is to explore the use of symptom monitoring and digital life coaching (DLC) to inform a more complete understanding of the impact of multiple myeloma on symptom burden, health self-efficacy, and financial, physiologic, and psychosocial well-being among a diverse U.S.-based, contemporary sample. The benefits of routine symptom monitoring have been demonstrated in recent studies, where overall survival increased among cancer patients who routinely monitored their symptoms. As the science related to symptom monitoring continues to evolve, exploring interventions to support both the assessment of and interventions related to disease and treatment-related sequelae it is important to identify how symptoms can best be monitored and managed. Studies to date have explored how symptom monitoring can be conducted for patients in the ambulatory setting, where patients do not receive around the clock assessment and management as they would in the hospital setting. In this context, digital or eHealth technologies are increasingly emerging as ways to promote health behaviors, and to monitor individuals with chronic health states, including cancer. An integrative review of 28 articles specifically evaluating eHealth interventions for patients with cancer identified 16 unique eHealth interventions, largely centered around educational support and decision aids. Telehealth counseling and navigation was found to be effective in supporting psychosocial needs in a small study (n=20) of underserved (defined by the authors as those who were primarily unemployed and uninsured) breast cancer patients. In a study of 1371 cancer patients, 71% reported using a mobile phone daily and 93% reported having internet access from home, of which 68% reported daily internet use, suggesting that internet-based technologies may be purposeful in the sharing of information with and coordination of care for cancer patients. Despite literature indicating its potential efficacy, few interventional studies have been published that evaluate digital health coaching and its relationship with self-efficacy and symptom management, specifically in R/R MM patients. As such, there is a gap in the literature on how digital health coaching might be used to support patients during cancer treatment and into survivorship.

Pack Health, LLC is an independent, patient engagement company that was established in 2014 with the mission of helping patients access the right care for their condition and develop the self-management skills to achieve better health and overall well-being. Pack Health offers a symptom management program involving both interpersonal interactions as well as e-modules for patients diagnosed with cancer to better manage pain, fatigue, depression, anxiety and navigate their care more effectively through digital health coaching and tools.

A recent pilot study at UCSF conducted in collaboration with Pack Health examined the impact of digital life coaching (DLC) on symptom outcomes for individuals with MM undergoing upfront stem cell transplantation. Outcomes suggest the efficacy of a coaching program for engagement up to day +100 post-transplant, with 73% (n=11) DLC engagement and 94% PRO completion. A randomized study of DLC versus usual care in individuals with MM undergoing upfront stem cell transplantation is underway. However, patients with R/R MM (where the disease has come back after prior lines of therapy such as transplantation) may have unique needs. An opportunity exists to explore how a digital health coaching platform might be used for symptom monitoring and coaching during treatment for R/R MM for whom the chronic nature of therapy may influence both needs and outcomes in relation to a DLC intervention.

This is a prospective study of patients with R/R MM to evaluate the feasibility and preliminary outcomes of DLC and its potential to augment existing standards of care for patient support. Patients enrolled in the program will be assigned to a health advisor who will act as an educator and accountability partner, supporting patients as they experience treatment for R/R MM. Throughout the engagement, patient reported outcomes (PROs) will be collected at multiple time points to assess the patient status and will be used to explore relationships between medical management, health related quality of life (HRQoL), and engagement in the program. Patients will be enrolled and will complete all assessments at baseline, 30, 60 and 90 days after consent. Findings from this study will establish feasibility of a DLC intervention for individuals with R/R MM and provide greater insight into their symptom burden, health self-efficacy, and financial, physiologic, and psychosocial well-being through the integration of patient reported, wearable and clinical data.

A single cohort of 100 individuals with relapsed/refractory multiple myeloma will be enrolled in the study, all of which will be enrolled in a digital health coaching program and receive a Fitbit device for activity tracking.

PRO and Wearable Data Insights From Individuals With R/R Multiple Myeloma

Evaluating Patient-Reported Outcomes and Wearable Data Among Individuals With Relapsed/Refractory Multiple Myeloma

The Center for Adherence Support Evaluation (CASE) is a three-item questionnaire used to measure antiretroviral therapy adherence. This questionnaire was developed through the Special Projects of National Significance (SPNS) initiative called Assessing Existing Efforts to Increase Adherence to Medication. Patients take less than 5 minutes to answer the three unique questions, asking about their difficulty taking medications on time, average days per week with one dose missed, and the last time they missed a dose.

A 30-item measure of quality of life across 5 domains, including physical, emotional, social, role and cognitive), 8 symptoms, and items assessing global health and financial toxicity. Recall over the past week is scored primarily on a 4-point scale ranging from "not at all" to "very much". The instrument may be administered either on paper or electronically.

The Comprehensive Score for Financial Toxicity (COST) is an 11-item instrument used to measure the financial toxicity of cancer treatment, which has been demonstrated to be highly correlated with HRQoL (de Souza et al., 2017). This instrument was validated among individuals with advanced cancer and demonstrated high internal consistency (Cronbach's α \>.90) and highly correlated to HRQol (p=.05). The instrument consists of 11 items, utilizing a five-point ordinal scale ranging from (0- Not at all) to (4- Very much).

A 20-item measure of quality of life among individuals with multiple myeloma. It assesses a series of symptoms on a 4-point Likert scale ranging from 1 (Not at All) to 4 (Very Much).

The Patient Health Questionnaire-4 (PHQ-4) is a 4-item inventory rated on a 4-point Likert-type scale. Its items are drawn from the first two items of the 'Generalized Anxiety Disorder-7 scale' (GAD-7) and the 'Patient Health Questionnaire-8' (PHQ-8). Its purpose is to allow for very brief and accurate measurement of depression and anxiety.

The PRO-CTCAE is a validated bank of 124 items representing patient experience of frequency, severity, interference, amount, and presence/absence of 78 symptomatic toxicities from the CTCAE. Responses are scored from 0 (absent) to 4 (severe/very much). We will administer 2 PRO-CTCAE instruments for: severity and interference of blurred vision.

Minutes of physical activity will be collected via Fitbits provided to study participants

Daily step count will be collected via Fitbits provided to study participants

Duration of engagement with the digital health coaching platform

Frequency of engagement with the digital health coaching platform

Methods of engagement with the digital health coaching platform

A retention rate greater than or equal to 70%. Retention is defined as individuals who agree to participate in the digital health coaching program and complete the 3 months of engagement post-enrollment. Engagement is defined as the completion of 1 nudge (call, text, or email) per module out of 5 nudge opportunities

This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".

University of Washington

GlaxoSmithKline

Pack Health

All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data.

Participants have the option to participate in a one time interview about their treatment experience.

consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.

Kelly J Brassil, PhD

Jasper Olsem

Melody R Becnel, MD

Trenton Grossfeld, BS

This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc will be enrolled across 2 sites, The University of California San Francisco and The University of Texas MD Anderson Cancer Center. Consented participants will be enrolled in a 3-month digital health coaching program through which electronic patient reported outcomes and wearable activity data will be collected. Outcomes include treatment experience, quality of life, financial toxicity, treatment adherence, symptom burden and health self-efficacy. These will be captured by patient reported outcome measures including the Patient's Qualitative Assessment of Treatment- Real World (PQAT-RW), Patient Global Impression of Change/Severity (PGIC/S), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20), and the European QoL-5 Dimensions (EQ5D), Cancer Behavior Inventory-Brief Form (CBI-B), Center for Adherence Support Evaluation (CASE) Medication Adherence Index, Comprehensive Score for Financial Toxicity (COST) Instrument.

Clinical data, including treatment history, healthcare utilization, and co-morbidities, as well as demographic data will be collected via the electronic health record from each clinical site. This data will be complemented by qualitative data from a selected cohort of study participants with a focus on treatment experience ranging from infusion burden, toxicity management, to overall quality of life. Evaluation of this data in combination will be used to better understand the treatment experience of individuals on standard of care isatuximab-irfc specifically, and with relapsed or refractory multiple myeloma generally, contributing to an existing gap in the literature regarding patient reported outcomes from diverse data sources. Outcomes will be analyzed with attention to the relationship between social determinants of health, including race, ethnicity, and geographic location, and treatment experience as reflected in both the qualitative and quantitative data.

A single cohort of 50 individuals with relapsed/refractory multiple myeloma will be enrolled in the study, all of which will be enrolled in a digital health coaching program and receive a Fitbit device for activity tracking. Individuals from both study sites will be enrolled to this single cohort.

Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma With Isatuximab

Clinical and Patient Reported Outcomes for Individuals With Relapsed/Refractory Multiple Myeloma Treated With Isatuximab: Real-World Insights From Patient Reported, Wearable, and Qualitative Data in the Context of Digital Health Coaching

Physical activity, including step count and minutes of physical activity will be collected via Fitbits provided to study participants

Frequency, types and duration of engagement with the digital health coaching platform

A 6-item survey assessing experience of a drug during clinical trial. The instrument consists of 3-free text and 3 scaled responses assessing the perceived benefits and disadvantages of received treatment and willingness to continue on drug after the study.

A one time interview will be conducted to learn more about the experience of individuals related to their diagnosis, treatment, symptoms, side effects and overall care experience.

A measure of quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

A 1-item measure of severity of relapsed/refractory multiple myeloma symptoms since the last visit, which is scored a on a 5-response scale ranging from "none" to "very severe".

A 1-item measure of patient perception of change in relapsed/refractory multiple myeloma symptoms since starting a study. Responses are scored on a 7-point scale, ranging from "very much worse" to "very much better".

M.D. Anderson Cancer Center

Sanofi

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Lung Neoplasms

Stomach Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Stomach Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

In addition to standard of care services at the participant's respective health system, and study specific collection of clinical, PRO, and wearable data, as well as microbiome specimens, individuals randomized to the intervention group will receive immediate enrollment to a 6-month digital health coaching program followed by 6 months monitoring via PRO, wearable, and clinical data collection. They will collect fecal microbiome samples at baseline (study enrollment) and month 6 following enrollment.

In addition to standard of care services, individuals in the wait list control will be monitored via the collection of PRO, clinical, and wearable data for the first 6 months, along with fecal microbiome collection at study enrollment baseline (study enrollment) and month 6. At month 6 these individuals will be enrolled into the 6-month digital health coaching program, during which clinical, PRO and wearable data will continue to be collected. At the completion of the 6-month coaching these individuals will come off study and will not receive additional follow-up.

A cohort of consisting of adults without a cancer diagnosis residing in the same residence as participants, will be consented to collect fecal microbiome specimens to serve as a control for potential regional variation in microbiome dysbiosis. Up to 25 healthy controls will be enrolled per 100 participants at each study site. At sites enrolling fewer than 100 participants, an n up to 25% of the total patient enrollment sample will be approached for enrollment.

Coaching consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.

Device: Fitbit A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.

Angela R Starkweather, PhD, FAAN

Debra L Lynch Kelly, PhD, FAAN

Marilyn Hammer, PhD

Alexi Wright, MD, MPH

Rachael Schmidt, DNP

Robin M Lally, PhD

Kristen L Fessele, PhD

Laura Flora, BA

Elizabeth Arthur, PhD

Jessica L Krok-Schoen, PhD

Meagan Whisenant, Phd

Darcy Ponce, BS

Meagan Whisenant, PhD

Debu Tripathy, MD

Abbey Kaler, MSN

Kaukab I Jafry, MD, MBBS

Martha Thompson

Anneliese Gonzalez, MD

Alexi Wright, MD

Jessica Krok-Schoen, PhD

Robin Lally, PhD

Angela Starkweather, PhD

Debra Lynch-Kelly, PhD

Kristen Fessele, PhD

This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 500 individuals with diverse cancer diagnoses will be enrolled across up to 5 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.

Background: There are an estimated 16.9 million cancer survivors in the United States, accounting for approximately 5% of the entire US population, and this number is anticipated to increase by 31% over the next 10 years to include 22.2 million individuals.1 Due to advances in therapy individuals with cancer are experiencing increased overall survival that is often accompanied by the management of cancer as a chronic condition.2 As such many individuals require maintenance therapies that extend for months or years beyond the completion of primary therapy with surgery, radiation, and/or pharmacologic therapies. Chronic management of cancer care may include both long-term maintenance therapy as well as the management of treatment-related sequelae, the majority of which occurs beyond the clinical setting. Supportive care needs include symptom support, general wellness, and a focus on the importance of adherence to treatment and follow-up, all of which may influence quality and quantity of life. Accordingly, there is a critical and growing need for comprehensive, accessible platforms to support survivor self-management of symptoms and general wellness (including physical, functional, and psychosocial well-being and healthcare adherence). There is furthermore a critical knowledge gap on the correlation between individual symptoms and wellness on novel biomarkers, specifically intestinal (gut) microbiome. Gut microbiome regulates critical physiological processes-digestion, mood, and overall immune health, but to date studies have focused on dysbiosis during cancer treatment. The investigators seek to explore dynamics of gut microbiota after cancer treatment and understand how health behavioral changes prompted by health coaching to modulate symptoms and physical/ psychosocial well-being may also positively influence the restoration of gut flora.

Aims: The objective of this randomized, wait-list control study is to assess the effect of a 6-month digital health coaching program in cancer survivors within 1 year of primary treatment and longitudinally measure its impact on multifaceted health outcomes. The investigators aim to: 1) Primarily, assess the feasibility, acceptability, and effect of digital health coaching on participants' health self-efficacy; 2) Secondarily, characterize associations between participant symptoms, physical/psychosocial well-being, and health self-management and gut microbiota changes; and 3) Explore patient-generated health data outcomes among participants (patient-reported \[PROs\] and wearable biometrics outcomes).

Methods: The proposed study will utilize a randomized-wait list control design to enroll up to1500 individuals with diverse tumor types who have completed primary treatment and are within 1 year of diagnosis. Each of up to 15 collaborating sites will enroll 100 participants. Participants will be enrolled in a 6-month digital health coaching program that combines person-to-person calls once weekly, accompanied by up to 4 digital nudges of evidence-based content via text, email and/or mobile application, based on the participant's preference. Content will focus on key topics designed to optimize survivorship outcomes, including management of late and long-term effects of therapy, diet and exercise, fatigue, financial toxicity, and other associated symptoms (e.g., sleep disturbance, depression), medication adherence, surveillance, and managing anxiety and fear of cancer recurrence. The program emphasizes targeting modifiable behaviors that can improve quality of life and health outcomes, including progression-free and overall survival. Those randomized to the intervention group will receive the 6-month coaching intervention up front followed by 6 months of on-going clinical, patient reported, activity, and microbiome data collection. Those randomized to the control will receive 6-months of clinical, patient reported, activity, and microbiome data collection, after which they will be randomized to the digital health coaching intervention.

Outcome Measures: All participants will be followed for 12-months during which time they will be provided with Fitbit devices to track engagement in physical activity. Microbiome samples will be collected at enrollment and 6 months to explore biomarkers of inflammation, which will be analyzed to examine associations between microbiota signatures and engagement in physical activity and PROs. Genomic bacterial DNA will be extracted and analyzed for any taxonomic changes in the microbiota diversity and composition with 16s rRNA sequencing. Microbiome analysis will be conducted in partnership with The National Institute of Nursing Research (NINR). PROs will be collected at baseline and months 3, 6, 9, and 12 to track progress during and following the program and to provide insights into the experience of quality of life, symptom burden, mental health, cognitive function, sleep quality, sexual health, and financial toxicity.

Rationale: This program seeks to address survivors' total well-being, including co-morbid conditions, psychosocial wellness, and healthy lifestyle behaviors, to enhance outcomes for individuals who have completed primary therapy for a cancer diagnosis. The approach is innovative in exploring how digital health coaching may be used to support the holistic needs of cancer survivors beyond the clinical care setting. The robust collection of patient-reported, wearable, biomarker, and clinical data, as well as qualitative data related to patient priorities, concerns and challenges in the context of Health Coaching, will allow for triangulation of data to comprehensively inform the experience of individuals following primary therapy as they manage their health in the community setting.

Wait list control trial in which 100 patients will be randomized to receive either 6-months of digital coaching immediately followed by 6-months of monitoring or 6-months of monitoring followed by 6-months of digital health coaching. All participants will receive 12 months of patient reported outcomes collection and activity tracking via wrist-worn devices, as well as microbiome collection at baseline and month 6 only.

Comprehensive Outcomes for After Cancer Health

Comprehensive Outcomes for After Cancer Health (COACH): The Feasibility and Impact of an mHealth Augmented Coaching Program for Self-Management in Cancer Survivors

An electronic food diary assessment capturing dietary intake over the last 24 hours. The number of items

A three-item instrument used to measure medication adherence, asking about difficulty taking medications on time, average days per week with one dose missed, and the last time a dose was missed. Responses are on differing scales, with higher values meaning better adherence.

Step count will be collected via Fitbits provided to study participants

16s analysis of fecal microbiome specimens self-collected by participants

ER visits and unplanned hospitalizations as documented in the electronic health record

A 3-item questionnaire evaluating the following: 1) The digital health coaching program is easy to participate in; 2) the digital health coaching program is useful to me; 3) the digital health coaching program is relevant to my survivorship experience. Responses will be provided on a 10-point Likert scale ranging from 1 (Not at all) to 10 (Very Much).

A retention rate greater than or equal to 70%. Retention is defined as individuals who agree to participate in the digital health coaching program completing the 6-months of engagement post-enrollment.

A 6-item instrument measures how confident an individual is in engaging in certain health management activities. Responses are provided on a 10-point scale ranging from 1(not at all confident) to 10 (totally confident). A mean score is calculated for the instrument with a higher score indicating higher self-efficacy.

A 12-item instrument assessing respondents' abilities to perform physical tasks and activities of daily living. Items are scored on 5-point Likert scales, with higher scores indicating higher physical functioning.

A 27-item instrument using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much) to measure QoL across four dimensions: physical, social/family, emotional and functional. The FACT-G, validated for use with individuals with diverse cancer types, in addition to condition specific items as available by tumor type.

An 8-item instrument measuring indicators of anxiety with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater anxiety.

An 8-item instrument measuring indicators of depression with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater depression.

An 8-item instrument measuring indicators of cognitive function with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater cognitive impairment.

An 8-item instrument measuring indicators of sleep-related impairment with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater sleep-related impairment.

An 11-item instrument measuring indicators of male sexual function and satisfaction with a recall period over the last 30 days. Responses are provided on various 2- to 10-point scales across 10 domains: interest in sexual activity, orgasm ability, orgasm satisfaction, oral discomfort, oral dryness, satisfaction with sex life, erectile function. For each item on the instrument a higher score indicates more of the concept being described.

A 14-item instrument measuring sexual function and satisfaction for women with a recall period over the last 30 days. Responses are provided on various 2- to 10-point scales across 7 domains: interest in sexual activity, lubrication for sexual activity, orgasm ability, orgasm pleasure, oral discomfort, oral dryness, satisfaction with sex life, vaginal discomfort, vulvar discomfort-clitoral, vulvar discomfort-labial. For each item on the instrument a higher score indicates more of the concept being described.

An 11-item instrument measuring the financial toxicity of cancer treatment utilizing a five-point ordinal scale ranging from (0- Not at all) to (4- Very much).

An 16-item instrument measuring the financial toxicity of cancer treatment. The first 15 items are rated on an 11-point scale ranging from 0 (lowest financial toxicity burden) to 10 (most severe financial toxicity burden). A final item asks individuals to rank their overall financial situation at the time of the survey compared to prior to their cancer diagnosis, using a 5-point response ranging from much better to much worse.

A 10-item instrument measuring the presence of commonly observed symptoms in individuals with a cancer diagnosis (9 specific items and 1 allowing entry of other problems). Responses for a recall period of the last 24 hours are recorded on an 11-point scale ranging from 0 (none/not present) to 10 (worst possible).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PRO and Wearable Data Insights From Individuals With R/R Multiple Myeloma	NCT05956457	Multiple Myelom... Relapsed Hemato...	Digital Health ... Fitbit	18 Years -	Pack Health
Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma With Isatuximab	NCT05053607	Multiple Myelom... Refractory Mult...	Digital Health ... Fitbit	18 Years -	Pack Health
Comprehensive Outcomes for After Cancer Health	NCT05349227	Ovarian Cancer Breast Cancer Lung Cancer Gastric Cancer Survivorship	Digital Health ... Fitbit	18 Years -	Pack Health

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