Dyadic Text-Messaging Micro-Intervention

NCT ID: NCT05917990

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-07-31

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.

Conditions

Advanced Cancer; Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dyadic Text-Messaging Micro-Intervention

Intervention Type: BEHAVIORAL

Participants receive text-messages consisting of information and skills relevant to improving couples' communication and relationship functioning.

Waitlist Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dyadic Text-Messaging Micro-Intervention

Participants receive text-messages consisting of information and skills relevant to improving couples' communication and relationship functioning.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karena Leo, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

1F32CA278417-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00113252

Identifier Type: -

Identifier Source: org_study_id