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Feasibility Testing and Evaluation of an Online Toolkit for Male Spouses of Women With Breast Cancer

NCT ID: NCT02058615

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-08-31

Brief Summary

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Male partners of women with breast cancer experience distress, so we want to develop a way to support them so they, in turn, can care for their wives. The purpose is to pilot test an online male spouse transition toolkit (MaTT) that the research team has developed. The specific aims are to: a) evaluate the Toolkit for ease of use, acceptability, and feasibility, and; b) collect preliminary data to determine potential effectiveness of the Toolkit in increasing hope, general self-efficacy and quality of life, and its potential effectiveness in decreasing guilt scores for male partners of women with breast cancer (stages 1-3).

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Male caregivers Breast cancer Intervention Online toolkit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Male Spouse Transition Toolkit

All participants in this group will be given access to the Male Spouse Transition Toolkit (MaTT). MaTT is a website based application that is designed to help male spouses of women with breast cancer to increase their awareness of the transitions and experiences they have as a husband and caregiver as well as to stay organized and seek help and resources as needed. To do so it consists of six sections: about me; common changes to expect; frequently asked questions; resources; calendar; and, important health information. These sections contain activities and exercises, as well as fillable templates (i.e., resources, calendar) that users can download at their convenience, from their home computer, tablet, or smart phone. They will be asked to use the MaTT for one month.

Group Type EXPERIMENTAL

Male Spouse Transition Toolkit

Intervention Type BEHAVIORAL

Usual Care

Participants in this group will not receive access to the Male Spouse Transition Toolkit, and thus will not receive an intervention. Data collection for outcome variables will be the same as the participants in the experimental arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Male Spouse Transition Toolkit

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* male
* 18 years of age or older
* living with a spouse who has breast cancer (Stage 1, 2, or 3)
* English speaking.

Exclusion Criteria

* persons who are non-autonomous adults
* cognitively impaired as determined by the Registered Nurse (RN) researcher
* unable to participate, in the opinion of the RN researcher
* non-English speaking
* does not have a spouse who is diagnosed with having breast cancer (State 1, 2, or 3)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian Breast Cancer Foundation

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Wendy Duggleby

Professor and Nursing Research Chair, Aging and Quality of Life

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy D Duggleby, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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25908

Identifier Type: -

Identifier Source: org_study_id