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Trial Title:
Dyadic Text-Messaging Micro-Intervention
NCT ID:
NCT05917990
Condition:
Advanced Cancer
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Conditions: Keywords:
Cancer
Couples
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Dyadic Text-Messaging Micro-Intervention
Description:
Participants receive text-messages consisting of information and skills relevant to
improving couples' communication and relationship functioning.
Arm group label:
Dyadic Text-Messaging Micro-Intervention
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Contact:
Last name:
Karena Leo, PhD
Phone:
919-416-3467
Email:
karena.leo@duke.edu
Start date:
March 2025
Completion date:
July 2026
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05917990
