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Completed

NCT Number: NCT02058615

Feasibility Testing and Evaluation of an Online Toolkit for Male Spouses 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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta

Edmonton, Alberta, T6G 1C9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Male Spouse Transition Toolkit

Behavioral

Primary outcomes

  1. Hope

    Time frame: Change from baseline at day 7, 14, 28, and 56

    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 outcomes

  1. Quality of Life

    Time frame: Change from baseline at day 7, 14, 28 and 56

    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 outcomes

  1. General self-efficacy

    Time frame: change from baseline at day 7, 14, 28, and 56

    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.

  2. Caregiver guilt

    Time frame: change from baseline at day 7 , 14, 28, and 56

    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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Breast Cancer Foundation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2014
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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