Clinical trial NCT01697982: Pilot Study of Living With Hope Program
Official title: Living With Hope: Pilot Study of Patient-Centered Hope Intervention for Persons Receiving Palliative Care Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: pilot study
psychosocial intervention
advanced cancer
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hope is important to palliative home care patients. Our research team has developed a Living with Hope Program that has been found to increase hope and quality of life in older persons with advanced cancer.

The investigators want to know if this program increases hope and quality of life for all palliative home care patients (all ages, all diagnosis). Thirty palliative home care patients and their care partners will participate in this pilot study to evaluate the study procedures and the living with hope program.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: McGill Quality of Life Questionnaire
timeFrame: Change from baseline in quality of life at Day 7
Secondary outcomes:
measure: Herth Hope Index
timeFrame: Change from Baseline in hope at day 7
Other outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline in HADS on day 7
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Wendy Duggleby, PhD
role: PRINCIPAL_INVESTIGATOR
References: