Feasibility Testing and Evaluation of an Online Toolkit for Male Spouses of Women With Breast Cancer
|ClinicalTrials.gov Identifier: NCT02058615|
Recruitment Status : Completed
First Posted : February 10, 2014
Last Update Posted : December 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Male Spouse Transition Toolkit||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Living With Hope: Development and Feasibility Evaluation of a Transition Toolkit for Make Partners of Women With Breast Cancer|
|Study Start Date :||March 2014|
|Primary Completion Date :||July 2015|
|Study Completion Date :||August 2015|
Experimental: 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.
|Behavioral: Male Spouse Transition Toolkit|
No Intervention: 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.
- Hope [ Time Frame: Change from baseline at day 7, 14, 28, and 56 ]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).
- Quality of Life [ Time Frame: Change from baseline at day 7, 14, 28 and 56 ]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.
- General self-efficacy [ Time Frame: change from baseline at day 7, 14, 28, and 56 ]General Self-efficacy is measured using the General Self-Efficacy Scale (GSES). This 10 item (0-4) Likert type scale produces a total perceived self-efficacy score. Higher scores indicate a higher self-efficacy or the confidence of one's ability to deal with adverse situations. It has a maximum score of 40.
- Caregiver guilt [ Time Frame: change from baseline at day 7 , 14, 28, and 56 ]Caregiver guilt is measured by the Caregiver Guilt Questionnaire. This 22 item scale measures guilt on a five-point Likert scale (0 "Never" to 4 "Always") with a total range between 0 and 88. A higher score indicates that the respondent experienced more feelings of guilt related to their care giving. Cronbach's alpha indicated excellent internal consistency at 0.926.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058615
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 1C9|
|Principal Investigator:||Wendy D Duggleby, PhD||University of Alberta|