Text Messaging for Gastrointestinal Cancer

Overseen By Karena Leo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: No mobile device, Too sick, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve communication skills for couples dealing with advanced gastrointestinal cancer. It tests a text-messaging program called the Dyadic Text-Messaging Micro-Intervention, designed to help partners share thoughts and solve problems together. Couples will either receive the program immediately or begin it after a short wait. The trial is suitable for couples where one partner is undergoing treatment for late-stage gastrointestinal cancer, and both can use a mobile device to communicate. As an unphased trial, this study offers couples a unique opportunity to enhance their communication skills during a challenging time.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves text messaging and communication skills, it seems unlikely that you would need to change your medication routine.

What prior data suggests that this text-messaging micro-intervention is safe for couples with gastrointestinal cancer?

Research shows that text-messaging programs, like the one under study, are usually easy for people to handle. Since this program emphasizes communication, it does not involve taking medicine or undergoing medical procedures, reducing the risk of side effects. Past studies on similar programs found that participants often had positive experiences, with very few negative reports. This study aims to help couples communicate better during difficult times, focusing on support rather than directly treating cancer. Given these points, this type of program is expected to be very safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dyadic Text-Messaging Micro-Intervention because it offers a novel way to support couples dealing with gastrointestinal cancer. Unlike traditional treatments that focus solely on medical interventions, this approach uses text messaging to enhance communication and strengthen relationships during a challenging time. By delivering information and skills through mobile technology, it aims to improve emotional well-being and problem-solving skills in real-time. This method stands out because it is accessible, can be easily integrated into daily life, and addresses the emotional and relational aspects of cancer care, which are often overlooked in conventional treatments.

What evidence suggests that this text-messaging micro-intervention is effective for improving communication in couples dealing with gastrointestinal cancer?

This trial will compare a Dyadic Text-Messaging Micro-Intervention with a waitlist control group. Studies have shown that small interventions, like the text-messaging program in this trial, effectively improve communication and relationships. Research indicates that these interventions help couples share thoughts and feelings more openly, solve problems together, and connect meaningfully. Although this approach is new for couples dealing with gastrointestinal cancer, similar methods have successfully encouraged healthy behavior changes and strengthened relationships in other contexts. Early findings suggest that this text-messaging strategy could help couples facing advanced cancer communicate better and support each other more effectively. ^{1 2 3 4 5}

Who Is on the Research Team?

Karena Leo, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for couples where one partner has advanced Stage III or IV gastrointestinal cancer and is undergoing systemic therapy like chemotherapy. Both partners must be fluent in English, in a committed relationship, and at least one should score ≥1.0 on the holding back screen.

Inclusion Criteria

My partner and I both speak and understand English fluently.

In a committed relationship

One or both partners must score ≥1.0 on the holding back screen

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Couples receive the text-messaging communication micro-intervention or are placed in a waitlist control group

4 weeks

2 visits (virtual)

Follow-up

Participants are monitored for changes in relationship satisfaction and communication

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dyadic Text-Messaging Micro-Intervention

Trial Overview The study tests a text-messaging micro-intervention aimed at improving communication skills between couples dealing with gastrointestinal cancer. Couples are randomly assigned to either receive this intervention immediately or placed on a waitlist control group.

How Is the Trial Designed?

Group I: Dyadic Text-Messaging Micro-Intervention Experimental Treatment 1 Intervention

The proposed micro-intervention will consist of 4 modules: welcome and overview module, sharing thoughts and feelings module, problem-solving skills module, and meaningful experiences and resources module. Each of the modules contain information and skills relevant to improving dyadic communication and relationship functioning in couples coping with advanced cancer.

Group II: Waitlist Control Active Control 1 Intervention

Couples in the waitlist control group will not initially receive any intervention materials; after completing post-assessment, couples in this arm will be offered the dyadic micro-intervention.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A randomized control trial involving 160 women with breast cancer will assess the effectiveness of a six-month text message support program aimed at improving health self-efficacy and various health outcomes compared to usual care.

The study will evaluate changes in self-efficacy, physical activity, dietary behaviors, mood, and quality of life, providing valuable data for future larger trials to support breast cancer survivors in their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A text message intervention to support women's physical and mental health after breast cancer treatments (EMPOWER-SMS): a randomised controlled trial protocol. Singleton, A., Partridge, SR., Raeside, R., et al.[2020]

The pilot study showed that a digital health intervention using Fitbit devices and SMS text messages is feasible for increasing physical activity in colorectal cancer patients during chemotherapy, with a high follow-up rate of 91% and good adherence to the Fitbit (80% of study days).

Participants expressed high satisfaction with the intervention, particularly with the Fitbit, but indicated a need for more personalized SMS content, highlighting the importance of tailoring digital health interventions to enhance engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II). Van Blarigan, EL., Dhruva, A., Atreya, CE., et al.[2022]

A study involving 387 e-mail users aged 42-73 showed that 74.4% were willing to send personalized e-mail messages to encourage colorectal cancer screening, indicating a strong potential for social support interventions.

Most participants who edited the message made changes to improve its tone and personalization without altering its meaning, suggesting that modifiable e-mail messages could effectively promote screening within social networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-mail to Promote Colorectal Cancer Screening Within Social Networks: Acceptability and Content. Cutrona, SL., Wagner, J., Roblin, DW., et al.[2018]

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]

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]

Citations

1. ctv.veeva.com ctv.veeva.com/study/dyadic-text-messaging-micro-intervention

Dyadic Text-Messaging Micro-Intervention - ClinicalTrials.Veeva The purpose of this study is to develop, refine, and pilot test a text-messaging micro-intervention focused on improving communication ...

2. withpower.com withpower.com/trial/phase-gastrointestinal-neoplasms-6-2023-cc9e4

Text Messaging for Gastrointestinal Cancer Trial Overview The study tests a text-messaging micro-intervention aimed at improving communication skills between couples dealing with gastrointestinal cancer.

3. clinconnect.io clinconnect.io/trials/NCT05917990

Dyadic Text-Messaging Micro-Intervention (NCT05917990) ClinConnect Summary. This clinical trial is looking at a new way to help couples communicate better when one partner has advanced gastrointestinal cancer.

4. sbm.secure-platform.com sbm.secure-platform.com/site/gallery/rounds/82001/details/16411

Development of a text-messaging communication micro ... Previous studies have found micro-interventions to be effective in promoting health behavior change and in enhancing relationship functioning among community ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10674151/

Feasibility of a Text Messaging–Integrated and Chatbot ... This study aims to bridge the gap in outpatient chemotherapy care by integrating a cutting-edge text messaging system with a chatbot interface.