Clinical trial NCT05917990: Dyadic Text-Messaging Micro-Intervention
Official title: Text-Messaging Communication Micro-Intervention for Couples Coping With Advanced GI Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Cancer
Gastrointestinal Cancer
Keywords: Cancer
Couples
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-06-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessment of acceptability of micro-Intervention
timeFrame: Post-Intervention (30 days post randomization)
measure: Changes in relationship satisfaction
timeFrame: Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)
measure: Changes in constructive communication
timeFrame: Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Karena Leo, PhD
role: PRINCIPAL_INVESTIGATOR
References: