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Living With Hope: Developing a Psychosocial Supportive Program for Rural Older Women Caregivers of Spouses With Advanced Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Advanced Cancer

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Trial Information

Living With Hope: Developing a Psychosocial Supportive Program for Rural Older Women Caregivers of Spouses With Advanced Cancer


1. Background: The research team has developed and pilot tested a Living with Hope Program
(LWHP) for caregivers of family members with advanced cancer. The LWHP includes viewing
an award winning Living with Hope video followed by writing a daily journal for two
weeks. The pilot test findings suggested that the LWHP is an acceptable and feasible
intervention for use by family caregivers. Although the LWHP shows promise in
potentially increasing hope and quality of life, further testing and development is
needed. Questions remain as to: a) what are the mechanisms through which the LWHP
affects outcomes and b) how long it is effective?

2. Purpose: The overall purpose of this time series mixed method study is the further
development and testing of the LWHP by:

1. Determining the mechanisms of the LWHP by testing the LWHP conceptual model in
which self-efficacy and loss and grief are hypothesized intervening variables for
changes in hope, and subsequently quality of life among rural women caring for
persons with advanced cancer. In the LWHP model we hypothesize that administration
of the LWHP will improve self-efficacy and decrease feelings of loss and grief.
This will lead to a positive influence on the proximal outcome of hope and the
distal outcome of quality of life.

2. Exploring the longitudinal effects of the LWHP on hope, quality of life and
health services utilization among older rural women caring for spouses with
advanced cancer. We want to determine if the LWHP has benefits beyond what was
found in the pilot. The team will compare baseline scores of hope and quality of
life to scores after the LWHP over time and health services utilization (one year
prospective number of physician visits and prescriptions compared to the year
before the LWHP). This study is unique, as it will follow caregivers over a
one-year period. As approximately 50% of these caregivers will become bereaved one
month after study enrolment; rather than dropping these caregivers from the study,
the team felt that retaining these subjects would add to the understanding of
hope, quality of life and health care utilization among caregivers by continuing
to follow them through bereavement. Thus, patterns of hope, quality of life and
health care services utilization will be delineated over time for active and
bereaved caregivers.

3. Research Plan: Using a time-series embedded mixed method design, baseline measures were
collected from 122 rural women caring for a person who has advanced cancer. Data
collection began January 2009 in 4 sites: Saskatoon Cancer Agency, Alan Blair Cancer
Agency, Sunrise Health Region and Regina/Qu'Appelle Health Region. Data collection in
Alberta started July 2010 through Alberta Health Services Community Cancer Clinics, and
in September 2010 through a mail out through the Alberta Cancer Registry. In January
2011 subjects were enrolled through a mail out through the Saskatchewan Cancer
Registry. Subjects who consented to participate in the full study received the LWHP.
Subjects were then post tested on the variables at 1 and 2 weeks, 3, 6 and 12 months.
Journal entries were copied and transcribed.

4. Data Analysis: Path Analysis will be used to test the model post LWHP at 1 and 2 weeks.
Two-factor ANCOVA will determine patterns over time and Cortazzi's narrative analysis
will be used to analyze the subjects journals completed as part of the LWHP.

5. Significance: This study will contribute to the refinement of the Living with Hope
Program that may improve quality of life and personal health of older rural women
caring for their spouse with advanced cancer and those who subsequently become
bereaved. The findings will also increase our understanding of the factors influencing
hope, quality of life and health in a vulnerable, understudied population that is
increasing in numbers with the aging of Canada's population. Family care giving is what
sustains patients at the end of life, and with changing demographics and diminishing
resources there is a potential that every Canadian will be an informal caregiver at
some time. Effective psychosocial supportive interventions, such as the LWHP are
critical for their support and well-being.


Inclusion Criteria:



- caring for a person who is diagnosed with advanced cancer, c) home address is outside
of metropolitan areas.

Exclusion Criteria:

- caring for a person with advanced cancer and dementia

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Herth Hope Index

Outcome Description:

The Herth Hope Index is a 12 item (1-4 point) Likert scale that delineates three sub-scales of hope: a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness71. These three subscales are consistent with descriptions of hope by caregivers in the preliminary work completed by the research team. The subscales also include measures of relationships and spirituality that are considered factors that influence hope. Summative scores range from 12-48, with a higher score denoting greater hope.

Outcome Time Frame:

Baseline, 1week, 2 weeks, 3, 6 and 12 months

Safety Issue:

No

Principal Investigator

Wendy D Duggleby, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alberta

Authority:

Canada: Ethics Review Committee

Study ID:

BEH 08-186

NCT ID:

NCT01081301

Start Date:

January 2009

Completion Date:

March 2012

Related Keywords:

  • Advanced Cancer
  • hope
  • quality of life
  • caregivers
  • Neoplasms

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