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Living With Hope: Pilot Study of Patient-Centered Hope Intervention for Persons Receiving Palliative Care Services


N/A
18 Years
N/A
Open (Enrolling)
Both
Quality of Life

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Trial Information

Living With Hope: Pilot Study of Patient-Centered Hope Intervention for Persons Receiving Palliative Care Services


Background: Hope is important for palliative home care patients (Duggleby, 2000; Duggleby,
et al., 2012; Duggleby & Wright, 2004, 2005). Our research team has developed a program
(Living with Hope) that has been found to increase hope and quality of life of palliative
home care patients (Duggleby et al., 2007). The Living with Hope Program (LWHP) involves
seeing a 15 minute film on hope and choosing a hope activity to begin over a one week time
frame. Participants choose to begin: a) a hope collection, b) a story about themselves, and
c) to write a letter to someone.

Aims: The purpose of this pilot study is to evaluate the feasibility of study procedures and
collect preliminary data on the effectiveness and processes of the Living with Hope Program
for persons receiving palliative home care in Alberta and Saskatchewan.

Sample: Palliative home care teams in Alberta and Saskatchewan will identify potential
participants based on the inclusion criteria. They will make contact and ask if the
potential participants are willing to talk with a research nurse about the study. If they
agree the research nurse will contact potential participants. Inclusion criterion for the
patients are: a) 18 years of age and older, b) English speaking, c) receiving palliative
home care services and d) able to complete the study as determined by their palliative care
coordinator/manager. Inclusion criterion for the care partner participants are: a)
identified by a palliative home care patient as being their primary source of physical
and/or emotional support, b) 18 years of age and c) English speaking.

The research nurse will contact potential participants and ask them when it will be a
convenient time to meet with and obtain written informed consent.

Design: Using a mixed-methods randomized control trial (Quant +qual) design, 30 dyads
(palliative care patient and their care partner) will be randomly assigned to one of three
groups: 1) treatment (Watching a film on hope and beginning a hope activity), 2) low dose
group (Film only) or 3) usual care group. In all groups, demographic information, and
baseline, day 7 and 14 measures of hope, quality of life and anxiety will be collected by
trained research nurses. On day 14 all participants will be interviewed using open ended
audiotaped questions to help evaluate the study procedures and those in group 1 and 2 the
LWHP program. Participants in group 1 (treatment group) will also be asked to describe what
they were thinking about when doing the hope activities. Care partners' levels of hope and
their evaluation of the study procedures (using open ended qualitative interview questions)
will also be collected.


Inclusion Criteria:



- Receiving palliative home care services and able to complete the study as determined
by their palliative care coordinator/manager.

- May or may not have an identified care partner.

Exclusion Criteria:

- Patients who are non-autonomous adults, cognitively impaired as determined by the
palliative care coordinator/manager and or unable in the opinion of the palliative
care coordinator/manager to participate

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

McGill Quality of Life Questionnaire

Outcome Description:

McGill Quality of Life Questionnaire: The MQOL is a 16 numerical rating scale designed to measure subjective well-being in palliative care patients. It is comprised of five sub measures: physical symptoms, physical well-being, psychological well-being, existential well-being and support. The scores reflect subjective well-being in each domain as well as a total quality of life score that is a mean score of the 5 sub-measures. The total scores range from 0-10 where the higher the scores indicate a higher the quality of life. The MQOL takes approximately 10 minutes to complete. There are no ceiling or basement effects. The MQOL has been found to be a reliable (r=.9) and valid measure of quality of life in palliative care patients.

Outcome Time Frame:

Change from baseline in quality of life at Day 7

Safety Issue:

No

Principal Investigator

Wendy Duggleby, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alberta

Authority:

Canada: Ethics Review Committee

Study ID:

Pro00033340

NCT ID:

NCT01697982

Start Date:

September 2012

Completion Date:

July 2013

Related Keywords:

  • Quality of Life
  • pilot study
  • psychosocial intervention
  • advanced cancer

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