NCT01081301

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 23, 2014

Completed
Last Updated

July 23, 2014

Status Verified

July 1, 2014

Enrollment Period

3.2 years

First QC Date

March 3, 2010

Results QC Date

November 6, 2013

Last Update Submit

July 22, 2014

Conditions

Keywords

hopequality of lifecaregivers

Outcome Measures

Primary Outcomes (1)

  • Herth Hope Index

    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) interconnectedness. 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.

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

Secondary Outcomes (4)

  • SF12 Mental Health

    baseline, 1 and 2 wks, 3, 6 and 12 months

  • General Self-Efficacy Score (GSES)

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

  • Non-Death Revised Grief Experience Inventory

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

  • SF12: Physical Health

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

Study Arms (1)

Living with Hope Program

EXPERIMENTAL

Receive Living with Hope Program

Behavioral: Living with Hope Program

Interventions

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.

Living with Hope Program

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • caring for a person with advanced cancer and dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E5, Canada

Location

Related Publications (3)

  • 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.

    PMID: 20065303BACKGROUND
  • 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.

    PMID: 20346156BACKGROUND
  • 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.

Related Links

Results Point of Contact

Title
Dr. Wendy Duggleby
Organization
University of Alberta

Study Officials

  • Wendy D Duggleby, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 5, 2010

Study Start

January 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 23, 2014

Results First Posted

July 23, 2014

Record last verified: 2014-07

Locations