NCT01697982

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

September 26, 2012

Last Update Submit

December 2, 2014

Conditions

Keywords

pilot studypsychosocial interventionadvanced cancer

Outcome Measures

Primary Outcomes (1)

  • McGill Quality of Life Questionnaire

    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.

    Change from baseline in quality of life at Day 7

Secondary Outcomes (1)

  • Herth Hope Index

    Change from Baseline in hope at day 7

Other Outcomes (1)

  • Hospital Anxiety and Depression Scale (HADS)

    Change from Baseline in HADS on day 7

Study Arms (3)

Living with Hope Program

EXPERIMENTAL

Participants will receive the Living with Hope Program (LWHP). The LWHP involves viewing a short film and choose to begin one of three hope activities: a) Write or ask someone to help you write one or more letters to someone begin to write a letter to someone, b) Begin a Hope Collection or c) begin an "About Me Collection."

Behavioral: Living with Hope Program

LWH Film

EXPERIMENTAL

Participants will viewing a short film entitled Living with Hope (LWH), which is based on the research team's grounded theory study, and shows cases of terminally ill persons and their family members talking about how they maintain their hope

Behavioral: LWH film

Usual Care

NO INTERVENTION

Participants in the usual care group will not receive an intervention. Data collection for outcome variables will be the same as the participants in the other arms.

Interventions

The Living with Hope Program involves viewing a short film entitled Living with Hope, which is based on the research team's grounded theory study, and shows cases of terminally ill persons and their family members talking about how they maintain their hope. Participants then choose to begin one of three hope activities: a) Write or ask someone to help you write one or more letters to someone begin to write a letter to someone, b) Begin a Hope Collection or c) begin an "About Me Collection."

Living with Hope Program
LWH filmBEHAVIORAL

Participants will view the Living with Hope film which is based on the research team's grounded theory study, and shows cases of terminally ill persons and their family members talking about how they maintain their hope.

LWH Film

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6M 2X1, Canada

Location

Study Officials

  • Wendy Duggleby, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Nursing Research Chair Aging and Quality of Life

Study Record Dates

First Submitted

September 26, 2012

First Posted

October 2, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations