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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058615
• Other study ID #: 25908
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2014
• Last updated: December 22, 2015
• Start date: March 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Male Spouse Transition Toolkit

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General self-efficacy	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.	change from baseline at day 7, 14, 28, and 56	No
Other	Caregiver guilt	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.	change from baseline at day 7 , 14, 28, and 56	No
Primary	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	No
Secondary	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	No