Back to resultsFeasibility Testing and Evaluation of an Online Toolkit for Male Spouses of Women With Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Male Spouse Transition Toolkit
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Male caregivers, Breast cancer, Intervention, Online toolkit
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)
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Male Spouse Transition Toolkit
Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02058615
First Posted
February 6, 2014
Last Updated
December 22, 2015
Sponsor
University of Alberta
Collaborators
Canadian Breast Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02058615
Brief Title
Feasibility Testing and Evaluation of an Online Toolkit for Male Spouses of Women With Breast Cancer
Official Title
Living With Hope: Development and Feasibility Evaluation of a Transition Toolkit for Make Partners of Women With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
Canadian Breast Cancer Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Male caregivers, Breast cancer, Intervention, Online toolkit
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Male Spouse Transition Toolkit
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Male Spouse Transition Toolkit
Primary Outcome Measure Information:
Title
Hope
Description
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).
Time Frame
Change from baseline at day 7, 14, 28, and 56
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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.
Time Frame
Change from baseline at day 7, 14, 28 and 56
Other Pre-specified Outcome Measures:
Title
General self-efficacy
Description
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.
Time Frame
change from baseline at day 7, 14, 28, and 56
Title
Caregiver guilt
Description
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.
Time Frame
change from baseline at day 7 , 14, 28, and 56
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy D Duggleby, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C9
Country
Canada
12. IPD Sharing Statement
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Feasibility Testing and Evaluation of an Online Toolkit for Male Spouses of Women With Breast Cancer
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