Dyadic Text-Messaging Micro-Intervention

Not Applicable

Not yet recruiting

• Conditions: Gastrointestinal Cancer; Advanced Cancer
• Interventions: Behavioral: Dyadic Text-Messaging Micro-Intervention

• Registration Number: NCT05917990
• Lead Sponsor: Duke University

Brief Summary

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).

Detailed Description

A cancer diagnosis requires patients and their intimate partners to communicate effectively to navigate illness-related challenges. Research indicates that couples who use effective communication strategies have better individual psychological adjustment and higher relationship satisfaction. However, many couples have difficulty communicating about cancer-related issues which can lead to poorer individual, relationship, and patient health outcomes.

While dyadic interventions to improve couple communication have proven efficacious, they are often time intensive and have limited reach. The challenges of recruiting couples into dyadic interventions are well-documented, with low recruitment rates especially among underserved couples.

Micro-interventions, which consist of brief educational materials and short activities delivered via text message or a mobile application, have significant potential to increase reach and participation in diverse groups of couples by increasing flexibility and reducing barriers to access. Previous studies have found micro-interventions to be effective in promoting health behavior change in a wide range of individuals and in enhancing dyadic functioning in community couples.

The proposed project aims to develop, test, and examine the feasibility, acceptability, and efficacy of a text-messaging communication micro-intervention for couples coping with advanced GI cancer.

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Study Start: 2025-06
• Primary Completion: 2026-06
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. In a committed relationship
2. Both members of the couple must read and speak fluent English
3. One partner must be diagnosed with advanced (Stage III or IV) gastrointestinal cancer and undergoing systemic therapy (e.g., chemotherapy)
4. One or both partners must score ≥1.0 on the holding back screen

Exclusion Criteria

1. Patient or partner who is unable to provide informed consent as assessed by the oncologist or research staff
2. Patient or partner is physically impaired in such a way that precludes the use of a mobile device
3. Patient or partner who do not have a mobile device
4. Patient or partner who is too sick to participate, as judged by the oncologist or research staff.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dyadic Text-Messaging Micro-Intervention	Dyadic Text-Messaging Micro-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.

Primary Outcome Measures

Name	Time	Method
Changes in constructive communication	Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)	Changes in constructive communication measured by the Communication Patterns Questionnaire (CPQ-Short Form)
Assessment of acceptability of micro-Intervention	Post-Intervention (30 days post randomization)	Acceptability of treatment will be measured using the Client Satisfaction Questionnaire (CSQ-8); higher scores indicate higher satisfaction
Changes in relationship satisfaction	Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)	Changes in relationship satisfaction measured by the Couples Satisfaction Index (CSI-4); higher scores indicate higher relationship satisfaction

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States