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

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
Living With Hope: Development and Feasibility Evaluation of a Transition Toolkit for Make Partners of Women With Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Male Spouse Transition Toolkit


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Male Spouse Transition Toolkit<br>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. | Behavioral: Male Spouse Transition Toolkit<br> <br> |
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hope | Hope is measured by the Herth Hope Index (HHI). The Herth Hope Index is a 12 item (1-4 point) Likert scale that delineates three sub-scales of hope: a) temporarility and future, b) positive readiness and expectancy, and c) interconnectedness. The HHI has been found to take approximately 5 minutes to complete. Summative scores range from 12-48, with a higher score denoting greater hope. This scale has been found to be reliable (test-retest r=91, p<0.05) and valid (concurrent validity, r=84, p.,0.05; criterion, r=92, p,0.05; divergent, r=-0.73, p. 0.05). | Change from baseline at day 7, 14, 28, and 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Caregiver quality of life is measured by the Caregiver Quality of Life-Cancer (CQOL-C) scale. This scale was developed specifically for family caregivers of persons with cancer. It consists of 35 items using a five-point Likert-type scale. It has four sub-scales: burden (physical and emotional), disruptiveness, positive adaptation and financial concerns. Higher scores reflect higher quality of life. It can be completed in 10 minutes and is considered easy to use. Test-retest reliability was found to be r=0.95 with an internal consistency of r=0.91. it was chosen for this study because it is easy to use and was developed based on quality of life studies of caregivers of persons with cancer. | Change from baseline at day 7, 14, 28 and 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male caregivers, Breast cancer, Intervention, Online toolkit