Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Uterine Cervical Neoplasms

Breast Neoplasms

Colorectal Neoplasms

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The usual care group received usual care that varies dependent upon the practice setting.

TIWeb (Tailored Web Intervention) program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.

CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.

TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.

Intervention: TIWeb program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.

TIWeb

Intervention: CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.

Intervention: The usual care group received usual care that varies dependent upon the practice setting.

Intervention: TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.

TIWeb+CSC

Victoria Champion, PhD

This study compares the efficacy (adherence and stage) of four interventions to promote colorectal (CRC) and breast cancer (BC) screenings among women ages 50 to 75. They are:

1. usual care;
2. a TIWeb (tailored intervention Website)
3. a CSC (cancer screening call) and
4. TIWeb + a CSC. This study also compares the cost-effectiveness of the 4 interventions to promote CRC and BC screening among women ages 50 to 75.

This study addresses innovative approaches to increase adherence to screening tests for colorectal and breast cancer - two cancers that have the greatest impact on female cancer mortality in the United States.The cancer burden in women could be significantly reduced by increasing participation in recommended screening for colorectal cancer (CRC) and breast cancer (BC) in all eligible women. This research tests intervention to simultaneously increase both CRC and BC screening using behavior change strategies, and also estimates the efficacy and cost-effectiveness of the interventions. Two groups of women, Group A (adherent to BC screening guidelines, but NOT to CRC screening guidelines) and Group B (non-adherent to BC \& CRC guidelines) are randomized to 1. Usual Care, 2. TIWeb, 3. CSC and 4. TIWeb +CSC.

We propose a prospective randomized 2x2 factorial design: 1)usual care; 2) a TIWeb; 3) a Cancer Screening Call (CSC), and 4 a TIWEB+ a Cancer Screening Call (CSC). The intervention will be tested in 2 groups of women. Group A will include women who are nonadherent to CRC but adherent to BC screening guidelines. Group B will include women who are nonadherent to both CRC and BC screening guidelines.

Increasing Colorectal and Breast Cancer Screening in Women

De-identified IPD will be made available to other researchers through a HIPAA compliant data storage system (Box Health) that is password protected.

any CRC test (either a stool test or colonoscopy) receipt of a stool test or a colonoscopy

Forward stage movement is the desired outcome -determining any forward stage movement in considering CRC screening either from Precontemplation to contemplation or from precontemplation to action

Comparing the cost-effectiveness of four conditions to promote CRC and BC screening , there will be differences in adherence to both CRC and BC screening and stage of adoption, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.

National Cancer Institute (NCI)

Indiana University

Distinguished Professor Edward and Sara Stam Culliper named Professor Associate Director Cancer Prevention and Control

Patients receive routine survivorship follow-up care at their doctor's office for 5 visits over 12 months. Caregivers will be followed for 3 visits over 6 months.

Patients and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment. Patients also participate in survivorship health education sessions over 75 minutes twice weekly for 4 weeks. They will participate in the EXCAP program as part of these sessions, which includes daily walking and resistance exercises.

Receive usual follow-up survivorship care

Best Practice

Comprehensive Geriatric Assessment

Participate in survivorship health education sessions

Educational Intervention

Exercise Intervention

Questionnaire Administration

Tailored Intervention

Caitlyn Hoffman

Desiree Goldstein

Lauren Barone

Erin Fukaya

Michele Lacy

Sarah Strause

sarah_strause@urmc.rochester.edu

Michelle Harmon

Heather Albertson

Amy Koffarnus

Deanna Cole

Supriya G Mohile

This phase III cluster randomized trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) to usual care on patient-reported physical function in older survivors of cancer. Survivorship care for older adults of cancer usually consists of getting advice from their doctor. This advice may include how to do their daily activities, so they are less tired or how to manage multiple diseases, or long-term side effects from treatment. GEMS may help improve the physical ability to perform activities of daily living, mental well-being, and memory in older survivors of cancer after chemotherapy. This study may help doctors learn if including GEMS in their practices improves physical, mental and memory functions in their patients. The study may also help to understand how such care affects cancer patients and their caregivers' quality of life.

PRIMARY OBJECTIVE:

I. To compare the efficacy of GEMS to usual care for improving patient-reported physical function (Functional Assessment of Cancer Therapy-Fatigue Physical Well-Being Subscale \[FACIT-PWB\]) in older cancer survivors at 6 months.

SECONDARY OBJECTIVE:

I. To compare the efficacy of GEMS to usual care for improving patient-reported cognitive function (FACT-cognitive function \[Cog\]) in older cancer survivors at 6 months.

OUTLINE: Practice sites are randomized to 1 of 2 arms. Participants are assigned to arms based on practice cluster.

ARM I: Patients receive routine survivorship follow-up care at their doctor's office for 5 visits over 12 months. Caregivers will be followed for 3 visits over 6 months.

ARM II: Patients and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment. Patients also participate in survivorship health education sessions over 75 minutes twice weekly for 4 weeks. Patients also participate in Exercise for Cancer Patients (EXCAP) program, which includes daily walking and resistance exercises.

Geriatric Evaluation and Management With Survivorship Health Education (GEMS) for Older Survivors of Cancer

Optimizing Functional Outcomes of Older Cancer Survivors After Chemotherapy

The FACIT-F is a 40-item questionnaire divided into 5 domains: physical well-being (PWB; 7-items), social/family well-being (SWB; 7-items), emotional well-being (EWB; 6-items), functional well-being (FWB; 7-items), and fatigue (13-items). Each question uses a 5-point rating scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; and 4=Very much).

We will test the efficacy of the GEMS intervention on self-reported physical function at 6 months by calculating the average between-arm difference in change in the FACIT-PWB subscale score from baseline to 6 months. To estimate the intervention effects, we will use an ANCOVA model with an additional random effect term to account for clustering.

The FACT-Cog provides an overall score and subdomain scores (perceived cognitive impairment (PCI), perceived abilities, comments from others, impact on quality of life) (37 items each with a 5 point Likert scale response). The secondary aim will be the FACT-Cog Perceived Cognitive Impairment score \[PCI\] at 6 months. We will apply the same analytical approach as for the primary aim to assess the intervention effect on FACT-Cog PCI and same statistical power considerations apply.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Increasing Colorectal and Breast Cancer Screening in Women	NCT03279198	Breast Cancer F... Colorectal Canc...	TIWeb CSC UC TIWeb+CSC	50 Years - 75 Years	Indiana University
Geriatric Evaluation and Management With Survivorship Health Education (GEMS) for Older Survivors of Cancer	NCT05006482	Malignant Solid...	Best Practice Comprehensive G... Educational Int... Exercise Interv... Questionnaire A... Tailored Interv...	65 Years -	University of Rochester

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