Dyadic Text-Messaging Micro-Intervention

NCT05917990 | Withdrawn

• 2 other identifiers: Pro001132521F32CA278417-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Cancer; Gastrointestinal Cancer

Keywords

Cancer; Couples

Outcome Measures

Primary Outcomes (3)

• Assessment of acceptability of micro-Intervention

  Acceptability of treatment will be measured using the Client Satisfaction Questionnaire (CSQ-8); higher scores indicate higher satisfaction

  Post-Intervention (30 days post randomization)

• Changes in relationship satisfaction

  Changes in relationship satisfaction measured by the Couples Satisfaction Index (CSI-4); higher scores indicate higher relationship satisfaction

  Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)

• Changes in constructive communication

  Changes in constructive communication measured by the Communication Patterns Questionnaire (CPQ-Short Form)

  Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)

Study Arms (2)

Dyadic Text-Messaging Micro-Intervention

EXPERIMENTAL

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.

Behavioral: Dyadic Text-Messaging Micro-Intervention

Waitlist Control

NO 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.

Interventions

Dyadic Text-Messaging Micro-Intervention BEHAVIORAL

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

Dyadic Text-Messaging Micro-Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Karena Leo, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 26, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)