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

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02058615
• Lead Sponsor: University of Alberta

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-10
• Study Start: 2014-03
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 57

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hope	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).

Secondary Outcome Measures

Name	Time	Method
Quality of Life	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.

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada