CancerNCT00161317
Evaluation of a Living With Hope Program
A study testing Living with Hope Program in people with Cancer, run by University of Saskatchewan.
Trial summary
The Living with Hope program was developed by the research team, a panel of experts and palliative patients and their families. The program was evaluated with 60 advanced cancer patients 60 years of age and older. Thirty received the program and 30 did not. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Living with Hope Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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-
About this study
Official title: Development, Implementation and Evaluation of a Psychosocial Supportive Hope Focused Program for Patients With Advanced Cancer
The Living with Hope program was developed by the research team, a panel of experts and palliative patients and their families. The program was evaluated with 60 advanced cancer patients 60 years of age and older. Thirty received the program and 30 did not. After one week, those receiving the Living with Hope Program had higher hope and quality of life scores compared to those who did not. This suggests that the program is effective in increasing hope and quality of life for older palliative care patients with cancer.
Read the 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.
- Conditions
- Cancer
- Being tested
- Living with Hope Program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living with Hope ProgramBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Hope (Herth Hope Index) and Quality of Life (MacGill Quality of Life Questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2003
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Investigators
- Wendy Duggleby, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161317
- Sponsor's protocol ID
- BSC 03-899
- Status last verified
- Jan 2016
- First submitted
- 8 Sep 2005
- Last updated
- 6 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation and Evaluation of a Psychosocial Supportive Hope Focused Program for Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00161317
- Acronym / sponsor ID
- BSC 03-899
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Feb 2006
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Living with Hope program was developed by the research team, a panel of experts and palliative patients and their families. The program was evaluated with 60 advanced cancer patients 60 years of age and older. Thirty received the program and 30 did not. After one week, those receiving the Living with Hope Program had higher hope and quality of life scores compared to those who did not. This suggests that the program is effective in increasing hope and quality of life for older palliative care patients with cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living with Hope Program | Behavioural | – |
Primary outcome
Hope (Herth Hope Index) and Quality of Life (MacGill Quality of Life Questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Duggleby principal investigator
University of Saskatchewan
Questions about this trial
What is this clinical trial studying?
A study testing Living with Hope Program in people with Cancer, run by University of Saskatchewan.
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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hope (Herth Hope Index) and Quality of Life (MacGill Quality of Life Questionnaire.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2016.