Behaviors and Mental Disorders

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Anxiety Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Gastrointestinal Agents

TEMPO

Aluminum hydroxide, magnesium hydroxide, simethicone drug combination

Antioxidants

Protective Agents

Using a stepped care approach, TEMPO will be provided across two intervention stages with variations on timing (initial vs. delayed) and intensity (self-directed vs. guided). All dyads will continue to access usual care (a co-intervention measure is included).

Patients will receive usual care throughout the study. Dyads in this group will not receive any information resources from the research team but will have access to all of those available at their participating center (sites will be asked to provide a description of usual care practices). Dyads not responding to active monitoring will be stepped up to TEMPO; responders to active monitoring will only be invited to complete the follow-up measures.

Stage 1 interventions (week 1-12): After 12 weeks, response will be determined. At recruitment, at least one member of the dyad must report anxiety symptoms defined as a Hospital Anxiety and Depression Scale (HADS)-Anxiety subscale score \> 6. After Stage 1, for the dyad to be "TEMPO Responder", both members' anxiety scores on the HADS-Anxiety must be \< 6 or decreased by at least 2 points. If both members of the dyad had anxiety symptoms at recruitment, then both must meet a response criterion. As soon as one dyad member does not meet the response criterion, the dyad is "TEMPO non-responder".

Stage 2 interventions (week 14-25): TEMPO responders continue with TEMPO. Non-responders will be re-randomized to: a) more time with TEMPO or b) add non-health care professional guidance (8 x 20-minute telephone calls). Guides' training will include TEMPO review, their role and the manual. Semi-structured exit interview will gather guides' experiences.

Stage 1 interventions (week 1-12): Patients will receive usual care throughout the study. Dyads in this group will not receive any information resources from the research team but will have access to all of those available at their participating center (sites will be asked to provide a description of usual care practices).

Stage 2 interventions (week 14-25): Dyads not responding to active monitoring will be stepped up to TEMPO; responders to active monitoring will only be invited to complete the follow-up measures.

Active Monitoring dyads' anxiety

Sylvie Lambert, PhD

Margit Fuchs, PhD

Manon de Raad

Men with prostate cancer and their family caregivers face many physical and emotional challenges from the cancer itself and its treatment(s), which often lead to high anxiety. The pandemic has highlighted the importance of protecting our physical and mental health, and the complex responsibilities that caregivers have in supporting their loved ones. To improve the health of men with prostate cancer and of their caregivers, the research team developed TEMPO: a self-directed Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram. TEMPO was developed with men with prostate cancer and their caregivers over the past 8 years. It also combines the investigators' research conducted over the past decade on providing the best support to those affected by cancer. Because the cancer care workforce is already overstretched, the research team designed TEMPO to be used without guidance from a health care professional. TEMPO is one-of-a kind in its support of both patients and caregivers, and the integration of coping skills training on a wide range of cancer challenges along with a home-based exercise program. Patients and caregivers who have used TEMPO said they improved their communication, learned new skills to cope with both physical and emotional challenges of cancer, and increased their physical activity. The present project builds on this work to further evaluate the cost and impact of TEMPO on men's and caregivers' health. Men with prostate cancer and their caregivers will be assigned by chance to one of two groups a) TEMPO or b) monitor their anxiety for 12 weeks. After 12 weeks, patients' and caregivers' needing more support will be identified based on an assessment of their anxiety level. For those already using TEMPO and needing more support, non-health care professional guidance might be offered. All those in the monitoring group needing more support will now have access to TEMPO. All participants complete surveys to determine whether TEMPO led to improved health outcomes.

BACKGROUND : Up to 60% of men with prostate cancer report some level of anxiety, with clinical levels exceeding population norm. Anxiety results from reactions to the diagnosis, treatment side effects, and the multitude of other anxiety-provoking physical and psychosocial challenges (e.g., treatment decision-making) men face daily. These challenges can be successfully mitigated through self-management, defined as one's actions and decisions to confidently manage medical aspects of cancer, cope with emotions, adjust everyday life, and enhance recovery (e.g., via lifestyle changes). Cancer care lags in the implementation of self-management support, mostly because it requires clinicians' engagement, which conflicts with their limited availability, even if self-management is cost-effective. Men then often lack knowledge for effective self-management; cancer challenges often persist, along with the anxiety they provoke. Cancer challenges are not self-managed in a vacuum; family caregivers are often relied on. The impact of caregiving is substantial, but often dismissed, resulting in high caregiver anxiety. TEMPO, a self-directed, dyadic Tailored, wEb-based psychosocial and physical activity self-Management PrOgram, was developed because staff shortages necessitate innovative models to deliver sustainable self-management support, without compromising efficacy. TEMPO is a tool to help address the quadruple aim of healthcare: enhance dyads' and clinicians' experiences and improve health outcomes at low cost. However, in a pilot study, some dyads needed more guidance to use TEMPO. Barriers to use were mostly motivational, which the investigators previously found can be effectively addressed by guidance from non-health care professionals to spare clinical resources.

OBJECTIVES : The goal of this study is to determine the most efficacious and cost-effective way of adapting TEMPO to dyads' needs for guidance. The primary hypotheses are that a) TEMPO dyads will experience lower anxiety than active monitoring dyads, but dyads needing guidance will report lower anxiety post guided TEMPO than if they had continued with TEMPO self-directed; and b) TEMPO will be cost-effective compared to active monitoring; adding guidance will demonstrate cost-effectiveness among those needing it. For the secondary hypotheses, same effects are expected of TEMPO and guidance on the secondary outcomes and between-group differences in anxiety will be higher among caregivers who are mostly females and women.

METHODOLOGY : This study is a Sequential Multiple Assignment Randomized Trial (SMART) with two sequential intervention stages, cost-effectiveness analysis, and exit qualitative interviews. Using a stepped care approach, TEMPO will be provided across two intervention stages with variations on timing (initial vs. delayed) and intensity (self-directed vs. guided). Dyads will initially be randomized to a) TEMPO self-directed or b) active monitoring of anxiety. After 12 weeks, TEMPO dyads still reporting anxiety will be re-randomized to more time with TEMPO or TEMPO plus guidance, and active monitoring dyads will be offered TEMPO. All participating dyads will continue to access usual care (a co-intervention measure is included). Group allocation will not be blinded. Dyads will be blinded to hypotheses to reduce bias. Research assistants (RAs) will not interact with randomized participants until the exit interview. Guides are not therapists; they focus on adherence, using TEMPO to answer dyads' questions. Phone calls start with the guide and dyad setting an agenda. Guides then ask about TEMPO's use since the last call. Guides conclude calls by reviewing dyad's goals until the next call. Stages 1 and 2 are 12 weeks each. Outcomes are assessed prior to randomization (baseline, T0) and at completion of Stage 1 (11 weeks post-randomization, T1) and Stage 2 (22 weeks post-randomization, T2).

Patient inclusion criteria are:

* Received treatment for prostate cancer (excluding active surveillance) within the past two years
* Identified a primary caregiver willing to participate in the study
* One member of the dyad has anxiety symptoms
* Has access to the internet,
* Understands English or French. Eligible caregivers will be those identified by the patient as his primary source of support. Caregivers also need to be able to read English or French.

Dyads exclusion criteria are:

* Either member of the dyad is hospitalized at recruitment

SIGNIFICANCE :This proposal builds on the investigators' innovative work on efficient, evidence-based dyadic self-management interventions that spare clinical resources but remains efficacious. Clinician partners emphasize the value of TEMPO in their letters of support. Twice as many centres are participating in this trial, compared to the pilot. The research team will make cost-effectiveness recommendations with clinical implementation in mind. Importantly, TEMPO has significant generalizability, as the tools and approaches can readily be adapted to other cancer populations (see letter from Stuart Edmond, Canadian Cancer Society). TEMPO is currently being adapted for use among patients with a head and neck cancer and their caregivers for implementation at the Centre Hospitalier de l'Université de Montréal. Several Cancer Agencies are exploring TEMPO's integration in their resource infrastructure. However, a definitive trial on efficacy, cost-effectiveness, and adaptation to meet dyad's needs for guidance is needed. The research team will also contribute to the emerging literature on SMARTs for behavioral interventions.

A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers

A SMART Design to Optimize the Delivery of TEMPO - a Tailored, wEb-based Psychosocial and Physical Activity Self-Management PrOgram for Men With Prostate Cancer and Their Caregivers

Patients and caregivers will each complete their own self-administered questionnaire at T0-T2 via Qualtrics, a secure electronic data capture system. HADS-Anxiety has strong reliability and validity to assess anxiety symptoms among dyads, including responsiveness. Our previous studies supported its ability to discriminate between anxiety and depression. To avoid testing effect, the HADS-Anxiety score obtained at eligibility screening will be used as baseline, if completed within 2 weeks of baseline, consistent with the HADS' test-retest reliability. In our SMART Coping-Together pilot, most dyads completed eligibility and baseline questionnaires within 1 week.

We will document TEMPO's key mechanisms of action: Primary appraisal = Perceived Stress Scale; secondary appraisal = PROMIS self-efficacy scale and the Multidimensional Self-Efficacy for Exercise Scale; self-management = Health Education Impact Questionnaire and Godin Leisure-Time Exercise Questionnaire (GLTEQ); coping = Dyadic Coping Inventory; depression = HADS-depression, and quality of life = SF-12. All measures were used in our pilot and have demonstrated psychometric properties. For physical activity, the modified GLTEQ is moderately correlated with pedometer and accelerometer derived activity data. Dyads will log weekly their step count in a Participant Steps Diary using the pedometer provided or their own devices.

Princess Margaret Hospital, Canada

University of Calgary

Sunnybrook Health Sciences Centre

University of British Columbia

McGill University

Simon Fraser University

Université de Sherbrooke

Memorial University of Newfoundland

Université de Montréal

Centre intégré de santé et de services sociaux (CISSS) de Laval

St. Mary's Research Center, Canada

Associate Professor

Heart and Blood Diseases

Nervous System Diseases

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Coronary Artery Disease

Stroke

Diabetes Mellitus

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Heart Diseases

Coronary Disease

Myocardial Ischemia

Ischemia

Vascular Diseases

Arteriosclerosis

Arterial Occlusive Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Familial risk assessment and personalized prevention messages

Louise S Acheson, MD, MS

Wendy S Rubinstein, MD, PhD

Suzanne M O'Neill, MA, MS, PhD

Mack T Ruffin IV, MD, MPH

The study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the U.S.

The purpose of this study is to evaluate the clinical utility of a new family history tool, Family Healthware™ by determining whether family history risk assessment and personalized prevention messages have any impact on health behaviors and use of medical services. The hypothesis to be tested is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services than patients who do not have their family history assessed and who receive only generalized (not personalized) prevention messages. An additional hypothesis, tested when participants see their primary care physician during the study, is that providing a copy of the graphical family history, risk and prevention messages to the patient's physician will increase delivery of recommended preventive services (screening, referral, and health habit advice).

The study will consist of enrolling approximately 8360 patients aged 35-65 years who attend primary care practices that are part of research networks affiliated with the three research centers. The practices will be randomized into two groups. Patients in practices randomized to Group 1 will complete a pre-test and the family history tool, and will receive personalized prevention messages based on their level of familial risk and current risk behaviors. After six months, Group 1 patients will complete a post-test. Patients in Group 2 will complete the pre-test and receive standard prevention messages (appropriate for sex) about maintaining good health and preventing disease. After 6 months Group 2 patients will complete the post-test and the family history tool. The pre- and post-test will include assessment of risk factors, use of medical services (especially preventive services), interest in modifying health behaviors, risk perceptions, etc. The analysis will compare changes in health behaviors between patients in Groups 1 and 2 and will also examine differences by familial risk strata (average, moderate, high).

Evaluating Tools for Health Promotion and Disease Prevention

Case Western Reserve University

American Academy of Family Physicians National Research Network

Evanston Northwestern Healthcare Research Institute

University of Michigan

Centers for Disease Control and Prevention

Breast Diseases

Skin Diseases

Quality of Life

Receive physical activity handout from the Canadian Public Health Agency

The Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities.

Participants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration).

Physical Activity Resource Kit

Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency

Standard Materials

Jeff Vallance, PhD

Celeste Lavallee, BSc, RD

Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.

The investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.

Primary Objective:

To compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).

Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy

University of Alberta

Alberta Health services

Athabasca University

Group will receive physical activity information targeted to young adult cancer survivors

Group will receive the Canadian Public Health Guidelines

Stride to Survive:An Exercise Guide for Young Adult Cancer Survivors

Canadian Physical Activity Guidelines

Young adult cancer survivors (YACS) are an understudied group in cancer survivorship research that have unique psychosocial, medical and survivorship issues. Physical activity (PA) has important effects on health-related outcomes in middle-aged and older cancer survivors and preliminary research suggests similar benefits in YACS (18-39 years). Unfortunately, only about half of YACS report meeting public health PA guidelines and there are no interventions or resources available to help YACS increase their PA. The purpose of this study is to test a physical activity guidebook that was developed for YACS based on the theory of planned behavior (TPB). The PA guidebook will be evaluated in a randomized controlled trial. Specifically, 300 YACS will be randomly assigned to (a) Canada's PA guidelines for adults or (b) the YACS PA guidebook. YACS will complete assessments of PA, quality of life, and psychosocial variables at baseline (prior to randomization), 1 month, and 3 months. The primary endpoint in the trial will be change in self-reported PA minutes from baseline to 3 months. Secondary endpoints will include changes in TPB constructs and quality of life. It is hypothesized that the group receiving the YACS PA guidebook (TARG) will report a greater increase in PA minutes compared to the group receiving Canada's PA guidelines (CPAG).

Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors

Effects of Targeted Versus Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors: A Randomized Control Trial

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Participants do not receive a reminder letter, which is treatment as usual.

Participants receive a reminder letter which is based on the current colorectal cancer screening invitation.

Participants receive a reminder letter which incorporates several behavioral components, including an active choice prompt, social norm, simplification, chunking and call to action.

Participants receive the behaviorally informed letter plus the colorectal home testing kit, which removes the current barrier of having to request a kit.

A reminder letter to encourage recipients to order the colorectal cancer home testing kit, based on the current invite letter.

Standard letter

A reminder letter to encourage recipients to order the colorectal cancer home testing kit, with incorporates severally behaviorally informed components, including an active choice prompt, social norm, call to action, chunking and simplification.

Behaviorally informed letter

The home testing kit is included with the reminder letter, instead of the usual process of responding to the letter to order the kit

Home testing colorectal cancer kit

Veerle Snijders

Tiina Likki

Ivana Brkić Biloš, MD

Nataša Antoljak, Prof

Colorectal cancer (CRC) is one of the leading causes of death in Croatia. An average of 3600 cases are diagnosed and an average of 2100 people die from the disease every year. Since 2007, Croatia has invited every man and woman aged 50-74 to participate in the home testing screening programme every two years. Currently only around 36% of the invited request the test-kit and 25% complete the home testing procedure, far below the target of 40-60%.

The Croatian Institute of Public Health with technical support from World Health Organization (WHO) Regional Office for Europe is undertaking a mixed-methods research study with the aim to increase the completion of colorectal cancer home testing and improve our knowledge of the barriers and drivers to do so. The study has a quantitative and a qualitative component:

1. Quantitative: testing the introduction of a reminder letter to encourage people to respond to the initial invite to participate in the CRC home test program and test which elements of a reminder letter improve response rates.

   The quantitative component consists of a four-arm reminder letter randomized controlled trial (RCT) comparing no letter, standard letter, behaviorally informed letter, and behaviorally informed letter sent with a home testing kit to investigate the effectiveness of reminders in increasing uptake of home-testing for colorectal cancer. Recruitment and data collection for the reminder letter trial will be conducted utilizing the routine screening process and routinely collected screening data.
2. Qualitative: conducting in-depth interviews with people from the target population who did or did not respond to the CRC invite letter and reminder to better understand the barriers and drivers to participation.

The qualitative component consists of 24 in-depth interviews (IDIs) conducted with members of the target population to identify barriers and drivers to completing colorectal cancer screening home-testing. Data collection for IDIs will be face-to-face, using discussion guides, and will be audio recorded. The audio-recordings will then be analyzed using a rapid analysis approach based on by the modified Capability-Opportunity-Motivation-Behavior (COM-B) framework.

Participants will be randomized to either control (no reminder screening invitation) or one of three treatments (standard reminder letter, behaviorally informed reminder letter, behaviorally informed letter with home testing kit included).

Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia

Using Behavioural and Cultural Insights to Understand and Address Barriers and Drivers to Colorectal Cancer Home-testing in Croatia

The study utilizes the data that is routinely collected as part the Croatian National Screening Database, only specific approved members of the screening program are able to access and utilize this data. For this reason, it is currently not planned to share individual participant data.

Did the participant order the colorectal cancer home testing kit? Routinely collected data.

Did the participant complete the home testing kit and return it to the health authority? Routinely collected data.

Did the participant actively opt out of participating in the screening program? Routinely collected data.

Qualitative feedback on the intervention arms and colorectal cancer screening experience. Collected through 24 semi-structured interviews.

Croatian Institute of Public Health

Andrija Štampar School of Public Health

Behavioural Scientist

Fatigue

Group will receive physical activity materials along with the implementation intention intervention and a booster again six weeks following.

Group will receive physical activity materials along with the implementation intention intervention.

Group will receive Canada's Food Guide which contains a small amount of physical activity information.

Will be given intervention and booster at six weeks

Two-time implementation intention

One-time implementation intention

Canada's Food Guide for Healthy Eating will be provided. This contains a small amount of physical activity information.

Sham Comparator

Thera-Bands, instructional DVD and exercise handout, instructional stretching handout, CSEP Physical activity guidelines.

Physical Activity Materials

Erin L McGowan, Ph.D

This trial is a three-armed randomized controlled trial which will explore the utility of an implementation intention intervention on aerobic and resistance exercise in older (60+) prostate and breast cancer survivors and improving quality of life. It is expected that those in the experimental groups will report greater increases in their physical activity, resulting in greater improvements in their quality of life.

Recruitment

Potential participants will be contacted by the Newfoundland and Labrador Cancer registry. They will be given a brief explanation of the study will be asked to consent to a mail-out questionnaire from the registry. The questionnaire will contain a cover letter explaining the study in more detail along with informed consent. If the participant wishes to continue in the study, they will return the questionnaire to the research team, who will contact them from this point.

Participants will also be recruited through presentations at local support groups as well as advertisements in local papers and posters at local hospitals and recreation centers.

Power Analysis

According to G\*Power a sample of 40 prostate and breast cancer survivors per group (n=120) is needed to detect a medium effect size (d= .50) on our primary outcome (i.e., PA) with a power of 0.80, at a p-level of 0.05. We expect a 20% attrition rate, based on previous research (McGowan, North, \& Courneya, 2013; Vallance, Courneya, Plotnikoff, Yasui, \& Mackey, 2007) therefore we will attempt to recruit a sample of 150 breast and prostate cancer survivors, which would allow for 50 participants per group.

Data Analysis

Analyses of covariance will be used to examine group differences on our primary outcome (i.e., PA minute/week) at month 1 and month 3, and secondary outcomes (e.g., QoL) at month 3. Additional analyses of covariance will be run to explore the group differences on sedentary behaviour, and light, moderate and vigorous minutes of activity/week at month 1 and month 3. Medical (e.g., comorbidities, months since diagnosis) and demographic (e.g., marital status, age, BMI) will be tested as possible moderators of PA behaviour change.

If we experience a large proportion of missing data multiple imputation techniques in SPSS will be used to replace missing values. Otherwise, a last outcome carried forward approach will be used.

The relationships between self-reported PA and QoL, and objectively measured PA and QoL in older breast and prostate cancer survivors will be explored. To examine this, differences in QoL between participants in the two PA categories (i.e., meeting PA guidelines and not meeting PA guidelines) will be tested using analysis of variance (ANOVA). These analyses will be repeated using analysis of covariance (ANCOVA) to control for the demographic and medical variables that had statistically significant associations with the QoL.

The relationship between objectively measured PA and self-reported PA will be explored using a two-way mixed intraclass correlation coefficient to calculate the level of absolute agreement between the two types of measurements.

Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors

Randomized Controlled Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors: The OutPACE Trial

Using Godin's Leisure Score Index, participants will be asked how much physical activity they took part in over the past seven days. Data from each time point will be analyzed and compared to determine change.

Participants will wear an accelerometer (ActiGraph GT3X) for seven days to assess their activity. Data from each time point will be analyzed and compared to determine change.

Will be assessed using the FACIT-F questionnaire. Data from each time point will be analyzed and compared to determine change.

Will be assessed using the short-form 36 scale (SF-36) and Functional Assessment of Cancer Therapy (FACT) questionnaire, specific to cancer type (FACT-Breast or FACT-Prostate). Data from each time point will be analyzed and compared to determine change.

Mitacs

Assistant Professor

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Participants will view a standard public health infographic about home air radon testing and will receive information about requesting a free home air radon test kit from their state radon program.

Participants will view an online health promotion intervention about home air radon testing, with messaging tailored based on whether the participant smokes or does not smoke. Participants will also receive information about requesting a free home air radon test kit from their state radon program.

Participants will view an online health promotion intervention about home air radon testing, with messaging tailored based on whether the participant smokes or does not smoke. Participants will also receive information about requesting a free home air radon test kit from their state radon program, as well as reminder messages about radon testing for about two months after initially viewing the online intervention component.

Participants will participate in a focus group discussion about radon testing and will receive a brief educational overview about radon testing.

Standard public health infographic about home air radon testing, plus information about requesting a free home air radon test kit

Public health infographic (AIM 3)

Online health promotion intervention with messaging about home air radon testing tailored by the participant's stated smoking status, plus information about requesting a free home air radon test kit

Online health promotion intervention tailored by smoking status (AIM 3)

Online health promotion intervention with messaging about home air radon testing tailored by the participant's stated smoking status, plus information about requesting a free home air radon test kit, plus reminder messages about home air radon testing sent over two months

Online health promotion intervention tailored by smoking status, plus reminder messages (AIM 3)

90-minute online focus group discussion about home air radon testing, plus an educational overview about home air radon testing using a standard public health infographic

Focus group with educational overview (AIM 1)

Stephanie Papas, MPH

Lisa A Purvis, EdD, MPH

Judith R Rees, BM, BCh, PhD

Rian M Hasson, MD, MPH

This study is about home air radon testing and has two phases.

The goal of the first phase is to learn about renters' and homeowners' views and plans related to radon testing. The main question this phase aims to answer is:

1. Does taking part in a focus group with information about radon testing change people's plans to test for radon?

Participants in the first study phase will:

* Take a survey about their views on and plans for radon testing.
* Take part in a focus group discussion about radon testing, during which they will receive information about radon testing.
* Right after the focus group, take a survey about their plans for radon testing.

The second phase is a pilot interventional study. The goal is to test interventions about radon testing with renters and homeowners who smoke and do not smoke. The main questions this phase aims to answer are:

1. Does the recruitment strategy result in enough participants enrolling within 3 months?
2. Will at least 80% of participants complete data collection activities?
3. Will more participants who view an online intervention developed by the researchers request free radon test kits, set them up in their homes, and complete radon testing, compared to participants who view a standard public health infographic? And will even more participants who receive reminder messages, in addition to the online intervention, request free radon test kits, set them up in their homes, and complete radon testing?

Participants in this second phase will:

* Take a survey about their views on and plans for radon testing.
* View an intervention about radon testing.
* Right after viewing the intervention, take a survey about their views on and plans for radon testing.
* 2 months later, take a survey about what, if any, steps they've taken to test their homes for radon.
* Provide the researchers permission to collect data from their State Radon Program on: a) whether they requested a free radon test kit and b) whether testing was completed.

Some participants will receive reminder messages for 2 months after viewing the intervention.

Researchers will compare an online intervention they developed about radon testing to: a) a standard public health infographic and b) their online intervention combined with reminder messages about radon testing. They will compare the interventions by proportion of participants who: a) request a free radon test kit from their State Radon Programs, b) set-up the radon test kit in their homes, and c) complete radon testing.

Healthy Homes Study

Co-developing and Pilot Testing a Risk-tailored, Technology-supported Intervention to Increase Home Radon Testing in New Hampshire and Vermont

Number of participants who consent into the study and meet eligibility criteria within 3 months of study opening to enrollment.

Proportion of study participants who complete all study-related surveys, including the pre-intervention survey, post-intervention survey, and follow-up survey at 2 months post-intervention.

Proportion of participants, by study arm, who request a free home radon test kit from the New Hampshire Radon Program or Vermont Radon Program in the 18 months following the intervention, the New Hampshire Radon Program or Vermont Radon Program, as reported by the state radon programs; radon test kits are attributed to participants if the state radon program records match the participant's name and/or address of home residence.

Proportion of participants, by study arm, who report setting up the a home radon test kit in their home at two months post-intervention.

Proportion of participants, by study arm who either: a) report completing radon testing via the follow-up survey at two months post-intervention, or b) submit a home radon test kit for analysis through the New Hampshire Radon Program or Vermont Radon Program, as reported by the state radon programs; radon test kits are attributed to participants if the state radon program records match the participant's name and/or address of home residence.

Intention to test will be measured on a scale of 0 to 10, with 0 indicating they definitely will not test their home air for radon and 10 indicating they definitely will test their home air for radon in the next 12 months.

Dartmouth-Hitchcock Medical Center

Associate Professor, Epidemiology; Associate Professor, Community & Family Medicine; Associate Director, Community Outreach and Engagement, Dartmouth Cancer Center

The POSTHOC app is a smartphone application that will deliver the Survivorship Care Plan and promote healthy lifestyle behaviors consistent with the individual's Care Plan

POSTHOC app

Amber Kleckner, PhD

At the end of cancer treatment, many patients are still dealing with symptoms of cancer and side effects of treatment. Many are also left in a surreal mental state with uncertainty regarding the future of their health. Survivorship Care Plans are plans that are provided to individuals at the completion of cancer treatment (i.e., chemotherapy, surgery, radiation). Survivorship Care Plans describe the details of a person's diagnosis and treatment, as well as provide recommendations for follow-up appointments, referrals, and healthy behaviors to accelerate recovery and prevent recurrence (e.g., diet, exercise, smoking cessation). Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes. Therefore, there is a need to digitize Survivorship Care Plans to improve the accessibility, modifiability, and longevity of the plan. In addition, with current technology, there is an opportunity for Survivorship Care Plans to be linked with mobile devices and activity trackers so that people can track health behaviors and compare them to their clinical goals, enabling people to take charge of their own health. Charles River Analytics developed an app called POSTHOC (POST-treatment Healthcare Outcomes for Cancer survivors) that digitizes the Survivorship Care Plan with goals to integrate it into the digital medical record.

Herein, phase I/II feasibility/preliminary efficacy randomized controlled trial is being conducted among 54 patients with cancer who recently completed adjuvant treatment for cancer (e.g., chemotherapy, radiotherapy, surgery) to compare 12 weeks of the POSTHOC app as part of the Survivorship Care Plan vs. the usual care Survivorship Care Plan on total symptom burden. Participants will be randomized 2:1, POSTHOC:usual care. Those randomized to the POSTHOC group will be provided with their Survivorship Care Plan via the app, and will choose to focus on nutrition or exercise for the duration of the study, based on their individual plan and personal preferences. At baseline, 6 weeks, and 12 weeks, patient-reported outcomes will be evaluated including total symptom burden, diet, and physical activity. Extensive quantitative and qualitative feedback will also be collected on the usability of the app from those in the POSTHOC arm in order to improve the app for future implementation studies.

Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors

Leveraging Technology to Address POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC-II): A Phase II Survivorship Care Plan Randomized Controlled Trial

The number of times participants log/view data in the app will be counted over the 12-week study

7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful

7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely

sum of severities of the core patient-reported symptoms from the MD Anderson Symptom Inventory, including fatigue, insomnia, pain, appetite loss, dyspnea (shortness of breath), cognitive problems, nausea, distress, and sensory neuropathy. A higher score indicates higher symptom burden

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers	NCT06363266	Cancer of the P... Anxiety	TEMPO Active Monitori...	18 Years -	St. Mary's Research Center, Canada
Evaluating Tools for Health Promotion and Disease Prevention	NCT00164658	Coronary Heart ... Stroke Diabetes Breast Cancer Ovarian Cancer Colorectal Canc...	Familial risk a...	35 Years - 65 Years	Centers for Disease Control and Prevention
Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy	NCT01053468	Breast Cancer	Physical Activi... Standard Materi...	18 Years - 75 Years	Athabasca University
Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors	NCT05450315	Behaviour Chang...	Stride to Survi... Canadian Physic...	18 Years - 39 Years	University of Alberta
Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia	NCT06341322	Colorectal Canc... Behavior Change	Standard letter Behaviorally in... Home testing co...	50 Years - 74 Years	World Health Organization
Evaluating Tools for Health Promotion and Disease Prevention	NCT00164658	Coronary Heart ... Stroke Diabetes Breast Cancer Ovarian Cancer Colorectal Canc...	Familial risk a...	35 Years - 65 Years	Centers for Disease Control and Prevention
Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors	NCT02321358	Quality of Life Physical Activi... Fatigue Breast Cancer Prostate Cancer	Two-time implem... One-time implem... Sham Comparator Physical Activi...	60 Years -	Memorial University of Newfoundland
Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia	NCT06341322	Colorectal Canc... Behavior Change	Standard letter Behaviorally in... Home testing co...	50 Years - 74 Years	World Health Organization
Healthy Homes Study	NCT05833334	Home Air Radon ... Lung Cancer	Public health i... Online health p... Online health p... Focus group wit...	18 Years -	Dartmouth-Hitchcock Medical Center
Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors	NCT05499663	Survivorship Cancer Symptoms and Si...	POSTHOC app	18 Years -	University of Maryland, Baltimore

Spots Global Cancer Trial Database for behavior change