Coaching and SMS for Cancer Survivors

(HABITS Trial)

Recruiting at 1 trial location

Overseen By Talia Williams, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Tennessee

Disqualifiers: Metastatic cancer, Unstable angina, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping cancer survivors maintain physical activity through various support methods. Participants will receive guidance from a peer coach, motivational text messages (SMS), a combination of both, or standard written materials. The goal is to determine which approach best supports ongoing physical activity among survivors. The trial seeks women aged 19 or older who identify as African American or Black, have a history of cancer, and have completed their main cancer treatments. Participants should be comfortable using video conferencing and texting and able to exercise independently several times a week. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for enhancing physical activity among cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you should not anticipate changes in your usual medications during the first 6 months of the study unless approved by the principal investigator (PI).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both peer coaching and text message (SMS) programs are generally safe for cancer survivors. Studies have not identified any major safety issues or negative effects with these methods.

When combined, peer coaching and SMS improve cancer survivors' quality of life and self-care without causing safety concerns. Participants have handled these methods well.

Using SMS alone offers a simple and acceptable way to support people with long-term illnesses, like cancer, without harm. SMS can keep patients engaged and is both affordable and effective.

Peer coaching involves trained cancer survivors helping each other. It has proven practical and helpful, reducing stress and improving mental health, with no reported safety problems.

In summary, these methods are safe and well-received for helping cancer survivors become more physically active. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support cancer survivors in maintaining physical activity, which is crucial for recovery and long-term health. Unlike traditional methods that might rely on written materials and self-motivation, this trial tests the effectiveness of peer coaching and SMS interventions. The Peer Coach approach provides personalized support and motivation from someone who has faced similar challenges, while the SMS intervention offers convenient, on-the-go reminders and encouragement. Combining these methods, the Peer Coach and SMS arm could provide a comprehensive support system, potentially leading to better adherence and improved outcomes for survivors.

What evidence suggests that this trial's treatments could be effective for increasing physical activity in cancer survivors?

This trial will evaluate different interventions to help cancer survivors stay active. Participants in one arm will receive both a peer coach and text messages, while another arm will focus solely on text message interventions. A separate arm will involve only peer coaching. Research has shown that having a peer coach and receiving text messages can help cancer survivors stay active. One study found that phone calls from peer mentors and text messages helped breast cancer survivors maintain their exercise routines. Another study showed that a program led by peers significantly increased the amount of moderate to vigorous exercise. For the text message approach, these interventions have been linked to better physical activity and preventing weight gain. Overall, both peer coaching and text messages have shown promise in helping cancer survivors remain active. ^{6 7 8 9 10}

Who Is on the Research Team?

Michelle Martin, PhD

Principal Investigator

University of Tennessee

Laura Q Rogers, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for African American or Black women, aged 19 or older, who are cancer survivors. They must be willing to attend video sessions, complete surveys, exercise independently 3-5 times a week, and have medical clearance. Exclusions include severe heart failure, contraindications to moderate exercise, high recent physical activity levels, planned surgeries that conflict with the study timeline.

Inclusion Criteria

Willing to complete surveys during study participation; if answered no, please explain

I am willing to join video calls for the study.

Identifies as African American or Black

Exclusion Criteria

I have heart failure that affects my daily activities.

Have a contraindication to engaging in moderate intensity aerobic exercise

Have completed on average, more than 90 min/week of moderate-intensity or more that 30 min/week of vigorous exercise in the past 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive interventions including SMS, peer coaching, or a combination to promote physical activity maintenance

15 months

Regular assessments at baseline, 3, 9, and 15 months

Follow-up

Participants are monitored for physical activity, fatigue, self-perceived health, quality of life, and other outcomes

15 months

Assessments at baseline, 3, 9, and 15 months

What Are the Treatments Tested in This Trial?

Interventions

• Peer Coach
• Peer Coach and SMS
• Short Message System (SMS)
• Usual Care

Trial Overview

The study tests how different support methods affect maintaining physical activity in cancer survivors. Participants may receive usual care only; motivational text messages (SMS); peer coaching via phone; or both SMS and peer coaching.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

Written materials focused on physical activity maintenance

Group II: Short Message Service (SMS) Experimental Treatment 1 Intervention

SMS intervention focused on physical activity maintenance

Group III: Peer Coach and SMS Experimental Treatment 1 Intervention

SMS and peer coach interventions focused on physical activity maintenance

Group IV: Peer Coach Experimental Treatment 1 Intervention

Peer coach intervention focused on physical activity maintenance

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

The Mobile-CEA system reduced the number of health personnel contacts for colorectal cancer (CRC) patients during a 2-year follow-up, with the Mobile-CEA group averaging 3 contacts compared to 5 in the standard surveillance group, indicating increased efficiency.

Patients using Mobile-CEA reported high satisfaction with the system, and health personnel found it to be a practical and safe tool for CRC surveillance, suggesting its potential as an effective follow-up method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile-CEA - A Novel Surveillance Method for Patients with Colorectal Cancer. Pakarinen, S., Varpe, P., Carpelan, A., et al.[2022]

In a pilot study involving 30 cancer patients, the use of a wearable activity tracker combined with personalized text message feedback led to 39% of participants increasing their daily steps by at least 20% over 3 months.

The intervention was well-received, with 72% of participants continuing to use the activity tracker at least 4 days a week after 6 months, suggesting it may effectively promote physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Koontz, BF., Levine, E., McSherry, F., et al.[2022]

In a study involving 75 adult cancer patients, daily text messages aimed at improving adherence to oral anticancer medications showed high acceptability, with 90% of participants satisfied with the intervention.

While the text message intervention led to improved adherence and perceived social support, the differences in symptom severity and interference between the experimental and control groups were not statistically significant, indicating the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proof of Concept of a Mobile Health Short Message Service Text Message Intervention That Promotes Adherence to Oral Anticancer Agent Medications: A Randomized Controlled Trial. Spoelstra, SL., Given, CW., Sikorskii, A., et al.[2023]

The EXCELSHC program, developed through interviews with 44 cancer survivors, aims to provide tailored health coaching for post-treatment care, addressing key needs like emotional support and health information.

The program is the first of its kind designed for primary care settings and is currently undergoing clinical efficacy trials to evaluate its effectiveness in supporting cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-Centered Development and Patient Acceptability Testing of a Health-Coaching Intervention to Enhance Cancer Survivorship Follow-up in Primary Care. O'Malley, DM., Davis, SN., Amare, R., et al.[2023]

A text messaging system was developed and tested with input from adolescent and young adult (AYA) cancer survivors, showing high acceptability and feasibility for improving survivorship care, including reminders for late effect screenings.

Participants found the system useful for connecting with community resources and suggested it could enhance survivorship care visits and foster social networks among AYA survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a text messaging system to improve receipt of survivorship care in adolescent and young adult survivors of childhood cancer. Casillas, J., Goyal, A., Bryman, J., et al.[2018]

Colorectal cancer survivors identified various barriers to completing surveillance colonoscopy, including individual, interpersonal, and system-level challenges, but expressed a positive attitude towards receiving SMS reminders to help overcome these obstacles.

The study suggests that SMS reminders should be personalized, include educational content, and start no earlier than 9 months post-surgery, indicating a tailored approach could enhance the effectiveness of interventions aimed at increasing colonoscopy utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message Preferences for Surveillance Colonoscopy Reminders Among Colorectal Cancer Survivors. Hohl, SD., Shankaran, V., Bell-Brown, A., et al.[2021]

The e-message service within a web-based self-management support system for breast cancer patients facilitated effective communication with healthcare providers, enhancing the quality of information and coordination of care.

Analysis of 91 dialogues showed that this service helped patients gain knowledge and take control of their care, although further research is needed to determine its impact on continuity of care and prevention of medical errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing errors through a web-based self-management support system. Ekstedt, M., Børøsund, E., Svenningsen, IK., et al.[2014]

The ConnectedCancerCare (CCC) intervention was found to be feasible and acceptable for women with early-stage breast cancer, with 82% of participants finding it easy to use and 86% willing to recommend it to others.

Women using CCC were more likely to schedule follow-up visits with their primary care provider and had better communication about provider roles, indicating that CCC may enhance patient engagement and knowledge in team-based cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention: a pilot randomized controlled trial. Wallner, LP., Abrahamse, P., Gargaro, JG., et al.[2023]

The LETSGO model, which involves nurse-led consultations and eHealth technology, was well-received by patients, who felt safer and more empowered in managing their health after cancer treatment.

Participants reported increased confidence in recognizing cancer recurrence symptoms and were motivated to enhance their physical activity, although some faced technical issues with the app that need to be addressed before wider implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led consultations reinforced with eHealth technology: a qualitative study of the experiences of patients with gynecological cancer. Skorstad, M., Vistad, I., Fegran, L., et al.[2022]

The EMPOWER-SMS COVID-19 program successfully enrolled 62.8% of participants (841 out of 1340) and demonstrated high engagement, with 99.3% of participants finding the SMS messages easy to understand and 84.8% considering them useful for support.

The program was delivered with high fidelity (97.43% of messages sent successfully) and low cost (approximately Aus $15.40 per participant), indicating it could be a sustainable option for supporting breast cancer survivors during challenging times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A National Health and Wellness SMS Text Message Program for Breast Cancer Survivors During COVID-19 (EMPOWER-SMS COVID-19): Mixed Methods Evaluation Using the RE-AIM Framework. Singleton, AC., Raeside, R., Hyun, KK., et al.[2023]

Text messaging (SMS) is a promising tool for enhancing cancer care by improving communication, adherence to treatment, and patient engagement, as it is more convenient and personalized than other methods like email.

Despite the potential benefits, there are currently few successful examples of SMS interventions in cancer care, highlighting a gap in implementation that needs to be addressed for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Messaging in Oncology: A Review of the Landscape. Mougalian, SS., Gross, CP., Hall, EK.[2019]

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