Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All 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

Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.

Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.

PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.

Prostate Cancer Education and Resources for Couples (PERC)

The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.

usual care plus NCI website

Lixin (Lee) Song, RN, PhD

In this study, the investigators propose to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC) in a randomized clinical trial. A two-group (PERC versus National Cancer Institute (NCI) website plus treatment as usual) randomized controlled design will be used, and data will be collected at baseline (T1), 4 (T2), 8 (T3), and 12 months (T4) among 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 600 participants in total).

This randomized clinical trial aims to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC). The study participants will include 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 300 dyads and 600 individuals). After informed consent, we will conduct baseline assessment (T1), randomly assign eligible participants to either PERC or the National Cancer Institute (NCI) website, and then collect data at 4 (T2), 8 (T3), and 12 months (T4) post-T1.

The investigator and data collectors will be masked to intervention.

Efficacy of a Couple-Focused mHealth Symptom Self-management Program

Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners

FACT-G will be used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Functional assessment of Cancer Therapy-General (FACT-G) is a 27 item survey which assesses physical, social/family, emotional, and functional well being on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. Higher scores indicate better well-being.

PROMIS Pain Interference - Short Form 6b will be used to measure change in Pain Interference among patients and their partners from Baseline (T1) to T2 (4 months post-T1), T3 (8-mon post-T1), and T4 (12-mon post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference.

PROMIS Fatigue -Short Form 7a will be used to measure change in Fatigue among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The fatigue sub-scale will measure the extent to which patients and their partners experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue.

PROMIS Sleep Disturbance Short Form 8b will be used to examine change in sleep quality of patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The sleep disturbance sub-scale measures the extent to which participant experience sleep disturbance over the past 7 days using a 5-point Likert scale. Higher scores reflect greater sleep disturbance.

PROMIS-Emotional Distress-Anxiety Short Form 7a will be used to examine change in anxiety among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale, where higher scores reflect higher anxiety.

PROMIS-Emotional Distress-Depression Short From 8b will be used to measure change in depression scores among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale, where higher scores indicate greater depressive symptoms.

The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC will be used to measure change in health related quality of life scores among patients from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value. It contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.

The Prostate Cancer Related Symptoms Caregiver Short Form will be used to measure changes in caregiver scores from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value.The questionnaire is a 4-item assessment about how the patient's hormone, sexual, bowel, and urinary function has affected the caregiver over the past 4 weeks. Items are ranked on a 5-point Likert Scale where higher scores indicate greater bother associated with the patient's symptoms.

The Lewis Cancer Self-Efficacy will be used to measure change in patient and partner feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients will rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.

PROMIS Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

The ISEL-12 will be used to measure change in social support from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1) among patients and their partners. The ISEL-12 is a 12 item measure, where higher scores indicate greater social support. Change from baseline is the post-Baseline values minus the Baseline value.

Appraisal of Illness scale will be used to measure change in perception of prostate cancer and related issues among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.The Appraisal of Illness scale is a 20 item measure that uses Likert Scales ranging from Very False to Very True.

Change in Dietary Risk Assessment scores will be used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients and their partners will be asked how often they consume different foods over the past month or week and will respond using a Likert Scale to report how much of each food item they have consumed.

The Measure of Older Adult's Sedentary Time will be used to measure change in self-reported sedentary time from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants will self-report how much time they spend doing various sedentary activities during the past week.

National Institute of Nursing Research (NINR)

UNC Lineberger Comprehensive Cancer Center

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Financial Stress

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.

Cancer care is transitioned to a satellite site.

Care transition

Cancer care is not transitioned to a satellite site.

No care transition

Mark Fiala, Ph.D. MSW

Mark Fiala, Ph.D., MSW

There is very limited data on the utilization of National Cancer Institute Comprehensive Cancer Center (NCI-CCC) satellite sites in general. Of what is available, most is in regards to providing chemotherapy at facilities closer to patients' home. These "satellite chemotherapy infusion centers", typically community-based treatment locations at community hospitals/facilities, freestanding clinics, or mobile units, are reported to be well liked by patients who utilize their services and reduce their travel times and expenses. In these studies patients still remained in the care of their current provider and site and are required to travel to the site for clinical visits and other appointments. It is currently unknown if patients are willing to transfer their care to a different provider to alleviate travel burden. In addition, although increased travel burden has been lower quality of life in cross-sectional studies, no data exists suggesting that these reducing travel burden can improve these outcomes intra-patient, to the knowledge of the investigators.

The patient roles of the multiple myeloma clinical providers at the Siteman primary location have grown in recent years. The providers have determined a need to refer some patients to the satellite sites to relieve congestion at the site while also hopefully improving the clinical experience for those patients. This study is a natural experiment of this process.

Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

A Natural Experiment of Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

* Explore differences in participant experience between those that elect to transfer to a satellite site and those who decline to transfer.
* The Modified Treatment Burden Questionnaire will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 3 questions with answers ranging from 0 (not a problem) to 10 (big problem). The higher the score the more treatment burden the participant experienced.

* Explore differences in participant satisfaction between those that elect to transfer to a satellite site and those who decline to transfer.
* The Questionnaire on the Quality of Physician-Patient Interaction will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 14 questions with answers ranging from 1 (do not agree) to 5 (I fully agree). The higher the score the higher the quality of the physician-patient interactions.

* Explore differences in participant financial toxicity between those that elect to transfer to a satellite site and those who decline to transfer.
* The Comprehensive Score for Financial Toxicity will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 11 questions with answers ranging from 0 (not at all) to 4 (very much). The higher the score the less financial toxicity the participant experienced.

A sample of 20 patients, approximately 10 who decided to transfer and 10 who declined, will be surveyed in regards to the reason(s) for their decision as part of a sub-study. Patients who were not enrolled in the prospective portion of the study, either due to declining or not approached, will be allowed to enroll in the sub-study as long as they were offered the ability to transfer to a satellite site by their provider.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of a Couple-Focused mHealth Symptom Self-management Program	NCT03489057	Prostate Cancer	Prostate Cancer... usual care plus...	40 Years - 75 Years	UNC Lineberger Comprehensive Cancer Center
Providing Cancer Care Closer to Home for Patients With Multiple Myeloma	NCT05971056	Multiple Myelom...	Care transition No care transit...	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for care transition