Living With Hope Program for Rural Women Caregivers

NCT ID: NCT01081301

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-03-31

Brief Summary

Family caregivers of terminally ill persons describe hope as inner strength that will help them continue caregiving. Our research team has developed and pilot tested a Living with Hope Program (LWHP) for caregivers of family members with advanced cancer, with the goal of fostering hope and improving quality of life (www.usask.ca/nursing /research/livingwithhope). The caregivers involved in our pilot test found the LWHP easy to use and we found some evidence to suggest that the program may have increased their hope and improved their quality of life. We would like to further develop and test the LWHP by finding out more about how and how long it might work. We believe it will improve the quality of life of active and bereaved older rural women of persons with advanced cancer and may decrease the number of prescriptions and doctor visits over one year. Since rural women caring for persons with advanced cancer seem to have the least hope, we want to focus on them first before including other caregivers in our research. Two hundred rural women caring for a person with advanced cancer will be asked to take part in this study. Their feelings of control, loss and grief, quality of life and hope will be measured over a year. The numbers of time they visit their physician and how many prescriptions they have over the year will also be collected. This study will contribute to the refinement of a 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.

Detailed Description

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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Living with Hope Program

Receive Living with Hope Program

Group Type: EXPERIMENTAL

Living with Hope Program

Intervention Type: BEHAVIORAL

The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.

Interventions

Living with Hope Program

The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Wendy Duggleby

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy D Duggleby, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

Duggleby W, Holtslander L, Kylma J, Duncan V, Hammond C, Williams A. Metasynthesis of the hope experience of family caregivers of persons with chronic illness. Qual Health Res. 2010 Feb;20(2):148-58. doi: 10.1177/1049732309358329.

Reference Type: BACKGROUND

PMID: 20065303 (View on PubMed)

Duggleby WD, Williams AM. Living with hope: developing a psychosocial supportive program for rural women caregivers of persons with advanced cancer. BMC Palliat Care. 2010 Mar 26;9:3. doi: 10.1186/1472-684X-9-3.

Reference Type: BACKGROUND

PMID: 20346156 (View on PubMed)

Duggleby W, Williams A, Holstlander L, Cooper D, Ghosh S, Hallstrom LK, McLean RT, Hampton M. Evaluation of the living with hope program for rural women caregivers of persons with advanced cancer. BMC Palliat Care. 2013 Oct 9;12(1):36. doi: 10.1186/1472-684X-12-36.

Reference Type: DERIVED

PMID: 24106841 (View on PubMed)

Related Links

http://www.nursing.ualberta.ca/livingwithhope

Living with Hope Research Website

Other Identifiers

184186

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BEH 08-186

Identifier Type: -

Identifier Source: org_study_id