Dyadic Text-Messaging Micro-Intervention

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05917990
Collaborator
National Institutes of Health (NIH) (NIH)
140
2
36

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dyadic Text-Messaging Micro-Intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Text-Messaging Communication Micro-Intervention for Couples Coping With Advanced GI Cancer
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2026
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Assessment of acceptability of micro-Intervention [Post-Intervention (30 days post randomization)]

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

  2. Changes in relationship satisfaction [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

  3. Changes in constructive communication [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Duke University
  • National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Karena Leo, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05917990
Other Study ID Numbers:
  • Pro00113252
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2023