Quality of LifeNCT01697982
Pilot Study of Living With Hope Program
A study testing Living with Hope Program and LWH film in people with Quality of Life, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Living with Hope Program and LWH film
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Jul 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Living With Hope: Pilot Study of Patient-Centered Hope Intervention for Persons Receiving Palliative Care Services
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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- Living with Hope Program, LWH film
- Keywords
- pilot study, psychosocial intervention, advanced cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living with Hope ProgramBehavioural
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."
LWH filmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline in quality of life at Day 7
Secondary outcomes (1)
Herth Hope Index
The Herth Hope Index is a 12 item (1-4 point) Likert scale that delineates three sub-scales of hope: a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness. The HHI has been found to take approximately 5 minutes to complete. Summative scores range from 12-48, with a higher score denoting greater hope. The HHI has been found to be reliable (test-retest r=. 91, p<.0 05) and valid (concurrent validity, r=. 84, p<0. 05; criterion, r=. 92, p< 0.05; divergent, r=-0.73, p<0. 05). The HHI has been used in studies with terminally ill patients and family caregivers[54-55] with no reported difficulties in completion.
Measured: Change from Baseline in hope at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Duggleby, University of Alberta
- Investigators
- Wendy Duggleby, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697982
- Sponsor's protocol ID
- Pro00033340
- Status last verified
- Dec 2014
- First submitted
- 26 Sep 2012
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With Hope: Pilot Study of Patient-Centered Hope Intervention for Persons Receiving Palliative Care Services
- ClinicalTrials.gov ID
- NCT01697982
- Acronym / sponsor ID
- Pro00033340
- Conditions
- Quality of Life
- Keywords
- pilot study, psychosocial intervention, advanced cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Oct 2012 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Living with Hope Program | Experimental | Behavioral: Living with Hope ProgramParticipants 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." |
| LWH Film | Experimental | Behavioral: LWH filmParticipants 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
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 ProgramThe 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." | Behavioural | Living with Hope Program |
| LWH filmParticipants 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. | Behavioural | LWH Film |
Primary outcome
McGill Quality of Life Questionnaire
Time frame: Change from baseline in quality of life at Day 7
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.
1 secondary outcome
Herth Hope Index
Time frame: Change from Baseline in hope at day 7
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 4 Dec 2014.
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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, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living with Hope Program and LWH film in people with Quality of Life, run by University of Alberta at 1 site in Canada.
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 2 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 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
McGill Quality of Life Questionnaire (time frame: Change from baseline in quality of life at Day 7). 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 4 Dec 2014.