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

140 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop, refine, and pilot test a text-messaging micro-intervention focused on improving communication skills for couples in which one partner has gastrointestinal cancer. For the pilot testing portion of the study, couples will be randomized (1:1) to receive the text-messaging communication micro-intervention or to a waitlist control group. All couples will be asked to complete questionnaires before randomization and 30 days post-randomization. Couples in the waitlist control group will be offered the text-messaging micro-intervention after completing the second set of surveys (30-days post-randomization).

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 data supports the effectiveness of the treatment Dyadic Text-Messaging Micro-Intervention for gastrointestinal cancer?

Text messaging programs have been shown to support health self-management and improve adherence to treatment in cancer patients, as seen in studies with breast cancer patients and those taking oral anticancer medications. These programs are simple and effective in providing support for people with chronic diseases, suggesting potential benefits for gastrointestinal cancer patients as well. ^{1 2 3 4 5}

Is text messaging as a treatment generally safe for humans?

Text messaging interventions have been used in various studies with cancer patients to improve medication adherence and promote physical activity, and no safety concerns have been reported in these studies. ^{1 2 6 7 8}

How is the Dyadic Text-Messaging Micro-Intervention treatment for gastrointestinal cancer different from other treatments?

This treatment is unique because it uses text messaging to support patients with gastrointestinal cancer, aiming to improve adherence to their treatment plan by providing reminders and personalized support, which is more immediate and accessible than traditional methods like emails or phone calls. ^{1 2 5 9 10}

Research Team

Karena Leo, PhD

Principal Investigator

Duke University

Eligibility Criteria

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

In a committed relationship

My partner and I both speak and understand English fluently.

My partner has advanced gastrointestinal cancer and is receiving systemic therapy.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Text Messaging in Oncology: A Review of the Landscape. [2019]

2. United States 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. [2023]

3. England 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Cancer patient and survivor research from the cancer information service research consortium: a preview of three large randomized trials and initial lessons learned. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

E-mail to Promote Colorectal Cancer Screening Within Social Networks: Acceptability and Content. [2018]

6. Canada 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). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Text Messaging Intervention to Promote Self-Management for Patients Prescribed Oral Anticancer Agents. [2015]

8. Germany pubmed.ncbi.nlm.nih.gov

Quality of life among colorectal cancer survivors participating in a pilot randomized controlled trial of a web-based dietary intervention with text messages. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

Can wireless text messaging improve adherence to preventive activities? Results of a randomised controlled trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Impact of a web-based intervention supplemented with text messages to improve cancer prevention behaviors among adolescents: results from a randomized controlled trial. [2018]