Behaviors and Mental Disorders

All Conditions

Stress, Psychological

Behavioral Symptoms

Quality of Life

Participants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period.

Participants in this group will receive standard education.

The CBT skills target reducing anxiety, (e.g., relaxation), changing negative appraisals (e.g., cognitive restructuring), coping skills training (e.g., enhancing adaptive skills), behavioral activation, interpersonal skills (e.g., communication skills) and building or enhancing social networks. The intervention will be administered online, and each module will last about 1-hour.

Cognitive Behavioral Therapy (CBT)-based skills

Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer.

Standard Education

Sara Fleszar-Pavlovic, PhD

Frank Penedo

Frank Penedo, PhD

The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.

QOL and GI Outcomes in Malignancies

Psychosocial Determinants of Health-Related Quality of Life (QOL) and Gastrointestinal (GI) Functional Outcomes During Treatment for Malignancies

Perceived Stress Scale (Scale of 1-40 with higher scores indicating higher stress)

UCLA Loneliness Scale (Scale of 20-80 with higher scores indicating higher loneliness)

Interpersonal Support Evaluation List (12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support).

FACT-G7 (Scale of 0-28 with higher scores indicating better quality of life)

FACT FHSI-18 (Scale of 0-72 with lower scores indicating better quality of life)

GSRS (Scale of 0-78 with higher scores indicating worse gastrointestinal symptoms)

University of Miami

Professor

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Overweight

Obesity

Overnutrition

Nutrition Disorders

Body Weight

Dyads randomized to the Immediate Intervention Group will receive a "Welcome Box" at completion of the baseline assessment. The Welcome Box will include two of each of the following: 1) Letters describing the project logistics and the important roles of each dyad member); 2) WiFi-enabled Scales (with instructions to weigh daily); 3) Portion Doctor ®Tableware (with instructions to use the portion plates at least once a day); 4) Fitbit® Inspire Activity Monitors (with instructions to share data with the dyad member and the study office); and 5) Instructions on how to create a secured account on the DUET website and instructions for logging on.

Participants assigned to the Delayed Intervention Group will receive a "Welcome Box" which on the outside is identical (and also is comparably weighted with bottled water) to that given to the Immediate Intervention group. This box would include: 1) Letters describing the project logistics and the important roles of each dyad member; and 2) monthly online study newsletters on topics unrelated to diet and exercise, but still of interest to cancer survivors and dyad members such as coping with stress, reducing exposure to radiation, sun safety, etc. to enhance retention and will be offered the opportunity to receive the online intervention after completing final 6-month assessments.

Every week, each dyad member will receive a tailored text message that provides a new fun fact or that encourages them to log-on to the website to access findings of new research and how the results might apply to them. They will be directed to specific pages in the Web-based program and asked to select strategies from a list that they will practice during the upcoming week. Graphic displays of their progress will be provided along with SCT-based feedback. They will be directed to the website to record their behavioral goals for the upcoming week. Tips also will be provided for effective communication to enhance couple efficacy. All usage will be tracked to assess adherence.

eHealth Intervention

Wendy Demark-Wahnefried, PhD, RD

The purpose of this protocol is to conduct a 2-arm, single-blinded randomized controlled clinical trial (RCT) in which 56 dyads (defined as consisting of an overweight or obese cancer survivor of an obesity-related cancer and an overweight or obese "buddy" of his or her choosing) would be assigned either to a 6-month, diet- and exercise-based weight loss intervention delivered via an interactive website with tailored text messages, or to a 6-month wait-listed control group. The overall goals of the eHealth intervention are to reduce obesity and select circulating biomarkers (tumor necrosis factor alpha \[TNFα\], insulin, and insulin-like growth factor-1 \[IGF-1\]), as well as improve diet quality, physical activity, health-related quality of life (QoL), physical functioning and performance as compared to the control over the 6-month study period.

The specific aims of this protocol are to: 1) determine whether dyads (comprised of an overweight / obese cancer survivor and an overweight / obese buddy of his or her choosing) lose significantly more weight (kg) at 6-months when assigned to the eHealth intervention compared to a wait-listed control; 2) explore between-arm differences in score changes between baseline and 6-month follow-up for other key outcomes including measures of adiposity (e.g., waist circumference \[WC\] and body mass index \[BMI\]), blood pressure, diet quality, physical activity, health-related Quality of Life (QoL), physical functioning and performance; 3) Assess the impact of the intervention on select biomarkers associated with cancer risk and progression, e.g., tumor TNFα, insulin and IGF-1; and, 4) identify predictor variables associated with program efficacy, e.g., social support, self-efficacy, risk for depression, and dyad partner (spouse, relative, friend/neighbor).

Cancer survivors and their selected "buddies" who are interested in participating will be directed to a website that describes this study in detail. If interested, they will be asked to complete an online screener requiring information on race/ethnicity, gender, state of residence and eligibility criteria. Once interested participants are assessed for eligibility, consented and enrolled, they will be asked to complete online questionnaires that assess physical activity, dietary intake, health-related quality of life, risk for depression, self-efficacy, social support and barriers to diet resources. Finally, anthropometric measures, blood pressure, physical performance and circulating biomarkers will be collected in participants' homes by visiting study staff (whom the project manager will deploy after checking for a mutually convenient time for the 2-person dyad.

We anticipate enrolling 56 dyads of participants (2 per dyad). Each dyad will be randomized to either receive the intervention for 6 months or be placed on a 6-month waitlist and offered the opportunity to try the online intervention after final assessments are completed.

Assessors of anthropometric, physical function, patient reported outcomes and biospecimens are blinded to arm status

Daughters, dUdes, Mothers and othErs Fighting Cancer Together

Daughters, (dUdes), Mothers and othErs Fighting Cancer Together

There is no plan at the moment to share IDP.

1 item question that asks for relationship of chosen partner to cancer survivor

3-items that ask about income and perceptions of economic well-being

Godin Leisure Time Physical Activity Questionnaire (4-item survey) - individuals provide the number of minutes of vigorous, moderate and light physical activity per week. The minimum is 0 - theoretically, the maximum is 10,080 (the number of minutes in a week), then they are asked if this level of activity is "typical." The higher the number of minutes of totaled moderate + vigorous activity, the better.

Side-by-side, semi-tandem and tandem stances

Clark et al. survey (20 items). Respondents either affirm or deny that they can resist high fat, high calorie foods under a variety of situations. Individuals who have maximum willpower achieve the top score of 20, whereas those with lesser willpower score lower (the minimum score is zero)

Sallis et al. survey (6 items in total). Respondents rate themselves on each item from 0 to 100% on their level of confidence. The higher the total score (maximum of 100%) the better (Minimum 0%).

Sallis et al. instrument (4 items). Respondents rate the level of support they obtain to follow a healthy, low calorie diet on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)

Sallis et al. instrument (4 items in total) Respondents rate the level of support they obtain to increase their level of physical activity on a 5-point scale ranging from ("never"= 0 to "everyday" = 4. Individuals who have maximum support achieve the top score of 16, whereas those with lesser support score lower (the minimum score is zero)

(15 items in total) Respondents either affirm or deny common barriers to exercise. Individuals who report more barriers achieve the top score of 21, whereas those with fewer barriers score lower (the minimum score is zero) and that is considered better.

43-item assessment of co-morbid conditions (multiple choice) (modified by removing 1 item)

10-item Likert scale assessment of Quality of Life

6-item Likert scale assessment of Quality of Life

7-item scale to assess e-health literacy. Two items were added from eHEALS to understand consumer's interest in using eHealth in general.

7-item scale to assess health and e-health literacy. Two items were added from eHEALS to understand consumer's interest in using eHealth in general.

(10 items) Respondents either affirm or deny common barriers to low calorie diet.

(8 items) Likert scale assessment of depression

2 items that ask whether respondent has ever smoked \>100 cigarettes and current smoking status.

University of Alabama at Birmingham

Professor and Webb Endowed Chair of Nutrition Sciences, University of Alabama at Birmingham (UAB) Associate Director of Cancer Prevention and Control, O'Neal Comprehensive Cancer Center

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants enrolled at intervention sites will receive CATSytem-supported cervical cancer screening and treatment services. Interventions received will include: text messages to patients and algorithm-driven alerts to providers when guideline-adherent cervical cancer screening and treatment services are required including: initial and follow up cervical cancer screening, on site treatment, and referral tracking.

Participants enrolled at control sites will receive standard of care PMTCT services, with no CATSystem tracking or follow up

The CATSystem provider dashboard highlights patients with overdue services or those in need of outreach and sends automated, customized texts to support screening and treatment follow-up per national guidelines. Points of intervention and alerts include: cervical cancer screening and treatment counseling, initial and follow up cervical cancer screening per national guidelines, treatment for precancer and cancer, referral tracking and follow up. In addition, the CATSystem can securely store images of the cervix taken with colposcopes to allow for remote expert consultation if needed to correctly diagnose a patient or can be reviewed at clinical team meetings for input. Primary goals of the CATSystem are to increase rates of guideline-adherent cervical cancer screening/ rescreening and improve guideline-adherent treatment, referral, and follow-up rates of women with positive screens.

Cancer Tracking System (CATSystem)

Catherine Wexler, MPH

May H Maloba, MCH

John Ochieng, BA

May H Maloba

John Ochieng

Sarah Finocchario-Kessler, PhD

Natabhona Mabachi, PhD

Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care).

To help address system level barriers to cervical cancer screening, treatment, and follow-up in Kenya, investigators worked with end-users (providers and patients) to develop the Cancer Tracking System (CATSystem), a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care). Specific aims (SA) of the study are to (1) Implement and evaluate the efficacy of CATSystem to improve guideline adherent cervical cancer screening, treatment, referral and follow up, (2) Assess feasibility and acceptability of implementation of CATSystem in government run facilities using a human centered design approach, and (3) Calculate the costs and cost-effectiveness of the CATSystem to increase quality adjusted life years gained. Cervical cancer deaths can be prevented with early detection and treatment. This study will evaluate the public health impact of the CATSystem in improving cervical cancer screening, treatment, referral, follow-up, and the feasibility of scale up to other low resource settings.

Matched, cluster randomized controlled design

Evaluation of the Cancer Tracking System (CATSystem)

Implementing and Evaluating the Cancer Tracking System (CATSystem): A Systems Level Intervention to Improve Cervical Cancer Screening, Treatment Referral and Follow up in Kenya

Investigators will make data collected for aims 1 \& 2 available only upon request from users who meet eligibility. Data from aim 3 includes costing data for PMTCT services. These data will be shared openly at the dissemination meetings planned at the end of the study, which will include county and national health personnel. Furthermore, these data will be placed in a readily accessible public database.

Provide guideline adherent treatment and rescreening for the range of possible positive screen results: cervicitis, precancerous lesions (mild, moderate, severe), invasive cervical cancer. Participants who receive the guideline adherent treatment for their positive screen result will be coded as 1 or "yes". Participants who do not receive the guideline adherent treatment for their positive screen will be coded as 0 or "no".

The cost and cost-effectiveness of the CATSystem to improve Quality-Adjusted Life-Years (QALYs).

Compare the number of women screened for cervical cancer pre (12 month retrospective review of screening rates) and throughout the two-year enrollment period at all intervention and control sites.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
QOL and GI Outcomes in Malignancies	NCT04815746	Psychological A... Psychological A... Stress, Emotion...	Cognitive Behav... Standard Educat...	18 Years -	University of Miami
Daughters, dUdes, Mothers and othErs Fighting Cancer Together	NCT04132219	Cancer Overweight and ...	eHealth Interve...	18 Years -	University of Alabama at Birmingham
QOL and GI Outcomes in Malignancies	NCT04815746	Psychological A... Psychological A... Stress, Emotion...	Cognitive Behav... Standard Educat...	18 Years -	University of Miami
QOL and GI Outcomes in Malignancies	NCT04815746	Psychological A... Psychological A... Stress, Emotion...	Cognitive Behav... Standard Educat...	18 Years -	University of Miami
QOL and GI Outcomes in Malignancies	NCT04815746	Psychological A... Psychological A... Stress, Emotion...	Cognitive Behav... Standard Educat...	18 Years -	University of Miami
Evaluation of the Cancer Tracking System (CATSystem)	NCT06286462	Cervical Cancer	Cancer Tracking...	16 Years -	University of Kansas Medical Center

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