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Dyadic Text-Messaging Micro-Intervention

Primary Purpose

Advanced Cancer, Gastrointestinal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dyadic Text-Messaging Micro-Intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring Cancer, Couples

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Dyadic Text-Messaging Micro-Intervention

    Waitlist Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Assessment of acceptability of micro-Intervention
    Acceptability of treatment will be measured using the Client Satisfaction Questionnaire (CSQ-8); higher scores indicate higher satisfaction
    Changes in relationship satisfaction
    Changes in relationship satisfaction measured by the Couples Satisfaction Index (CSI-4); higher scores indicate higher relationship satisfaction
    Changes in constructive communication
    Changes in constructive communication measured by the Communication Patterns Questionnaire (CPQ-Short Form)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 13, 2023
    Last Updated
    August 28, 2023
    Sponsor
    Duke University
    Collaborators
    National Institutes of Health (NIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05917990
    Brief Title
    Dyadic Text-Messaging Micro-Intervention
    Official Title
    Text-Messaging Communication Micro-Intervention for Couples Coping With Advanced GI Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    July 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University
    Collaborators
    National Institutes of Health (NIH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Cancer, Gastrointestinal Cancer
    Keywords
    Cancer, Couples

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dyadic Text-Messaging Micro-Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Waitlist Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dyadic Text-Messaging Micro-Intervention
    Intervention Description
    Participants receive text-messages consisting of information and skills relevant to improving couples' communication and relationship functioning.
    Primary Outcome Measure Information:
    Title
    Assessment of acceptability of micro-Intervention
    Description
    Acceptability of treatment will be measured using the Client Satisfaction Questionnaire (CSQ-8); higher scores indicate higher satisfaction
    Time Frame
    Post-Intervention (30 days post randomization)
    Title
    Changes in relationship satisfaction
    Description
    Changes in relationship satisfaction measured by the Couples Satisfaction Index (CSI-4); higher scores indicate higher relationship satisfaction
    Time Frame
    Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)
    Title
    Changes in constructive communication
    Description
    Changes in constructive communication measured by the Communication Patterns Questionnaire (CPQ-Short Form)
    Time Frame
    Baseline (after informed consent, prior to randomization), Post-Intervention (30 days post randomization)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karena Leo, PhD
    Phone
    919-416-3467
    Email
    karena.leo@duke.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karena Leo, PhD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Dyadic Text-Messaging Micro-Intervention

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