Dyadic Text-Messaging Micro-Intervention

April 22, 2024 updated by: Duke University

Text-Messaging Communication Micro-Intervention for Couples Coping With Advanced GI Cancer

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Dyadic Text-Messaging Micro-Intervention
Participants receive text-messages consisting of information and skills relevant to improving couples' communication and relationship functioning.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of acceptability of micro-Intervention
Time Frame: Post-Intervention (30 days post randomization)
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
Time Frame: 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
Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)
Changes in constructive communication
Time Frame: 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)
Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Karena Leo, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00113252
  • 1F32CA278417-01 (U.S. NIH Grant/Contract: NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Cancer

Clinical Trials on Dyadic Text-Messaging Micro-Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe