Dyadic Text-Messaging Micro-Intervention

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05917990
• Other study ID #: Pro00113252
• Secondary ID: 1F32CA278417-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: July 2026

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: Karena Leo, PhD
• Phone: 919-416-3467
• Email: karena.leo[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: July 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Behavioral:
• Dyadic Text-Messaging Micro-Intervention
Participants receive text-messages consisting of information and skills relevant to improving couples' communication and relationship functioning.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)