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Advanced CancerPhase 2LWHNCT01081301

Living With Hope Program for Rural Women Caregivers

A Phase 2 study testing Living with Hope Program in people with Advanced Cancer, run by University of Saskatchewan at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Advanced Cancer
What is being tested?
Living with Hope Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesCanada
Study dates
Jan 2009to Mar 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • caring for a person with advanced cancer and dementia

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2G3

  • University of Saskatchewan

    Saskatoon, Saskatchewan, S7N 5E5

Other trials in Canada

About this study

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

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.

Read the 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:
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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
Being tested
Living with Hope Program
Keywords
hope, quality of life, caregivers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Living with Hope ProgramBehavioural

    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.

Study groups in NCT01081301
Study groupRoleWhat they receive
Living with Hope ProgramExperimentalReceive Living with Hope Program
Receives: Behavioral: Living with Hope Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. SF12 Mental Health

    The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).

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

  2. General Self-Efficacy Score (GSES)

    The scale consists of 10 items with responses from 1-4. The higher the Scores on the General Self Efficacy Scale (which has a range from 10 - 40), indicate higher participant feelings of self-efficacy. The General Self Efficacy Scale was chosen as a measure for this study because it has been found to be a reliable and valid measure in many populations.

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

  3. Non-Death Revised Grief Experience Inventory

    The Non-Death Revised Grief Experience Inventory measures grief that is not associated with the death of a person. It is a 22-item scale measuring four domains (existential concerns, depression, tension and guilt, and physical distress) of the grief experience. Responses are scored on a 6-point scale, ranging from slight disagreement to strong agreement, with higher total score indicating more grief and loss. The Non-Death Revised Grief Experience Inventory has a minimum score of 22 and a maximum score of 132.

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

  4. SF12: Physical Health

    The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01081301
Sponsor's protocol ID
BEH 08-186
Other IDs
184186
Acronym
LWH
Status last verified
Jul 2014
First submitted
3 Mar 2010
Last updated
23 Jul 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 20065303

  • 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.

    PubMed 20346156

  • 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.

    PubMed 24106841

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Living with Hope Program in people with Advanced Cancer, run by University of Saskatchewan at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Herth Hope Index (time frame: Baseline, 1week, 2 weeks, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01081301, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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