- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02058615
Feasibility Testing and Evaluation of an Online Toolkit for Male Spouses of Women With Breast Cancer
December 22, 2015 updated by: Wendy Duggleby, University of Alberta
Living With Hope: Development and Feasibility Evaluation of a Transition Toolkit for Make Partners of Women With Breast Cancer
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1C9
- University of Alberta
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hope
Time Frame: Change from baseline at day 7, 14, 28, and 56
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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).
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Change from baseline at day 7, 14, 28, and 56
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: Change from baseline at day 7, 14, 28 and 56
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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.
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Change from baseline at day 7, 14, 28 and 56
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General self-efficacy
Time Frame: change from baseline at day 7, 14, 28, and 56
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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.
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change from baseline at day 7, 14, 28, and 56
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Caregiver guilt
Time Frame: change from baseline at day 7 , 14, 28, and 56
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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.
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change from baseline at day 7 , 14, 28, and 56
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
August 1, 2015
Study Registration Dates
First Submitted
February 6, 2014
First Submitted That Met QC Criteria
February 6, 2014
First Posted (ESTIMATE)
February 10, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
December 24, 2015
Last Update Submitted That Met QC Criteria
December 22, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25908
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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