NCT02058615

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

February 6, 2014

Last Update Submit

December 22, 2015

Conditions

Breast Cancer

Keywords

Male caregiversBreast cancerInterventionOnline toolkit

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Quality of Life

    Change from baseline at day 7, 14, 28 and 56

Other Outcomes (2)

  • General self-efficacy

    change from baseline at day 7, 14, 28, and 56

  • Caregiver guilt

    change from baseline at day 7 , 14, 28, and 56

Study Arms (2)

Male Spouse Transition Toolkit

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Male Spouse Transition ToolkitBEHAVIORAL
Male Spouse Transition Toolkit

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male
  • years of age or older
  • living with a spouse who has breast cancer (Stage 1, 2, or 3)
  • English speaking.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 1C9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Wendy D Duggleby, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Nursing Research Chair, Aging and Quality of Life

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 10, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

CA(1)