- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00161317
Evaluation of a Living With Hope Program
Development, Implementation and Evaluation of a Psychosocial Supportive Hope Focused Program for Patients With Advanced Cancer
Study Overview
Detailed Description
The overall purpose of this study was to evaluate the effectiveness of a psychosocial supportive intervention called "Living with Hope Program" (LWHP) in increasing hope and quality of life for older adult community-living terminally ill cancer patients. Using a mixed method concurrent nested experimental design, 60 terminally ill cancer patients over the age of 60 years were randomly assigned to a treatment and control group. Baseline hope [Herth Hope Index (HHI)] and quality of life scores [McGill Quality of Life Questionnaire, (MQOL)] were collected at the first visit in the patients' homes by trained research assistants. Those in the treatment group received the LWHP, which consisted of viewing an international award winning video on hope and a choice of one of three hope activities to work on over a one-week period. The control group received standard care. Hope and quality of life data were collected one week later from both groups. Qualitative data using open-ended hope questions were collected from the treatment group.
Subjects receiving the Living with Hope Program had statistically significant higher hope (U=255, p=.005) and quality of life scores at visit two (U=294.5, p=.027) than those in the control group. Qualitative data confirmed this finding with the majority (61.5%) of subjects in the treatment group reporting the LWHP increased their hope. This preliminary evaluation of the effectiveness of the LWHP suggests that it may increase hope and quality of life for older terminally ill cancer patients at home.
Study Type
Enrollment
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion criteria for the study is; a) male or female 60 years of age and over, b) diagnosed with cancer, c) receiving palliative home care services d) English speaking, e) able to give informed consent and participate in the study as determined by the Palliative Care Coordinator or SWADD team's assessment.
Exclusion Criteria:
Exclusion criteria includes patients who are non-autonomous adults, cognitively impaired as determined by the SWADD team and or unable in the opinion of the SWADD team to participate-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Hope (Herth Hope Index) and Quality of Life (MacGill Quality of Life Questionnaire.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wendy Duggleby, University of Saskatchewan
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BSC 03-899
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