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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by University of Alberta
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Wendy Duggleby, University of Alberta
ClinicalTrials.gov Identifier:
NCT02058615
First received: February 6, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Behavioral: Male Spouse Transition Toolkit
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Hope [ Time Frame: Change from baseline at day 7, 14, 28, and 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline at day 7, 14, 28 and 56 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • General self-efficacy [ Time Frame: change from baseline at day 7, 14, 28, and 56 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058615

Contacts
Contact: Wendy D Duggleby, PhD 7804928660 wendy.duggleby@ualberta.ca

Locations
Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G 1C9
Contact: Wendy D Duggleby, PhD    7804928660    wendy.duggleby@ualberta.ca   
Principal Investigator: Wendy D Duggleby, PhD         
Sponsors and Collaborators
University of Alberta
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: Wendy D Duggleby, PhD University of Alberta
  More Information

No publications provided

Responsible Party: Wendy Duggleby, Professor and Nursing Research Chair, Aging and Quality of Life, University of Alberta
ClinicalTrials.gov Identifier: NCT02058615     History of Changes
Other Study ID Numbers: 25908
Study First Received: February 6, 2014
Last Updated: February 6, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Male caregivers
Breast cancer
Intervention
Online toolkit

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014