Dyadic Text-Messaging Micro-Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Cancer, Gastrointestinal Cancer

Intervention / Treatment
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* Behavioral: Dyadic Text-Messaging Micro-Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In a committed relationship Both members of the couple must read and speak fluent English One partner must be diagnosed with advanced (Stage III or IV) gastrointestinal cancer and undergoing systemic therapy (e.g., chemotherapy) One or both partners must score ≥1.0 on the holding back screen Exclusion Criteria: Patient or partner who is unable to provide informed consent as assessed by the oncologist or research staff Patient or partner is physically impaired in such a way that precludes the use of a mobile device Patient or partner who do not have a mobile device Patient or partner who is too sick to participate, as judged by the oncologist or research staff.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dyadic Text-Messaging Micro-Intervention<br>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<br>* Participants receive text-messages consisting of information and skills relevant to improving couples' communication and relationship functioning.<br>|
| No Intervention: Waitlist Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Couples