Trial Outcomes & Findings for Living With Hope Program for Rural Women Caregivers (NCT NCT01081301)

Results Overview

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. These three subscales are consistent with descriptions of hope by caregivers in the preliminary work completed by the research team. The subscales also include measures of relationships and spirituality that are considered factors that influence hope. Summative scores range from 12-48, with a higher score denoting greater hope.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Baseline, 1week, 2 weeks, 3, 6 and 12 months

Results posted on

2014-07-23

Participant Flow

In Saskatchewan, the Palliative Care Admission team in Regina Qu'Appelle Health Region and nurses at the Saskatchewan Cancer Agency also identified potential participants. In Alberta, the Alberta Health Services Cancer Care and Community Cancer Clinics in rural communities also identified potential participants.

Exclusion criteria were a) women who were cognitively impaired as determined by the recruitment team at the site, b) women otherwise unable to participate, in the opinion of the recruitment team and c) women caring for a family member who has a diagnosis of advanced cancer as well as dementia.

Participant milestones

Participant milestones
Measure	Living With Hope Program Receive Living with Hope Program Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.
Overall Study STARTED	36
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Living With Hope Program Receive Living with Hope Program Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.
Overall Study Bereaved	3
Overall Study Too busy	5
Overall Study Patient too ill	2
Overall Study Lost to Follow-up	4

Baseline Characteristics

Living With Hope Program for Rural Women Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Living With Hope Program n=36 Participants The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.
Age, Continuous	59 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Canada	36 participants n=5 Participants
Herth Hope Index	37.79 units on a scale STANDARD_DEVIATION 5.97 • n=5 Participants
General Self-Efficacy Scale	31.1 units on a scale STANDARD_DEVIATION 3.94 • n=5 Participants
Short Form Health Survey Version 2 - Mental Health	43.59 units on a scale STANDARD_DEVIATION 5.35 • n=5 Participants
Short Form Health Survey Version 2 - Physical Health	45.17 units on a scale STANDARD_DEVIATION 3.87 • n=5 Participants
Non-Death Revised Grief Experience Inventory	72.82 units on a scale STANDARD_DEVIATION 23.92 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1week, 2 weeks, 3, 6 and 12 months

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. These three subscales are consistent with descriptions of hope by caregivers in the preliminary work completed by the research team. The subscales also include measures of relationships and spirituality that are considered factors that influence hope. Summative scores range from 12-48, with a higher score denoting greater hope.

Outcome measures

Outcome measures
Measure	Living With Hope Program [Baseline] n=36 Participants	Living With Hope Program [Day 7] n=35 Participants	Living With Hope Program [Day 14] n=33 Participants	Living With Hope Program [3 Months] n=31 Participants	Living With Hope Program [6 Months] n=26 Participants	Living With Hope Program [12 Months] n=22 Participants
Herth Hope Index	37.79 units on a scale Standard Deviation 5.97	39.74 units on a scale Standard Deviation 4.96	39.06 units on a scale Standard Deviation 6.05	38.17 units on a scale Standard Deviation 5.22	39.34 units on a scale Standard Deviation 4.96	40.53 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: baseline, 1 and 2 wks, 3, 6 and 12 months

The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).

Outcome measures

Outcome measures
Measure	Living With Hope Program [Baseline] n=36 Participants	Living With Hope Program [Day 7] n=35 Participants	Living With Hope Program [Day 14] n=33 Participants	Living With Hope Program [3 Months] n=31 Participants	Living With Hope Program [6 Months] n=26 Participants	Living With Hope Program [12 Months] n=22 Participants
SF12 Mental Health	43.59 units on a scale Standard Deviation 5.35	45.27 units on a scale Standard Deviation 5.66	44.15 units on a scale Standard Deviation 6.40	45.57 units on a scale Standard Deviation 5.76	44.52 units on a scale Standard Deviation 5.66	47.15 units on a scale Standard Deviation 5.36

SECONDARY outcome

Timeframe: Baseline, 1week, 2 weeks, 3, 6 and 12 months

The scale consists of 10 items with responses from 1-4. The higher the Scores on the General Self Efficacy Scale (which has a range from 10 - 40), indicate higher participant feelings of self-efficacy. The General Self Efficacy Scale was chosen as a measure for this study because it has been found to be a reliable and valid measure in many populations.

Outcome measures

Outcome measures
Measure	Living With Hope Program [Baseline] n=36 Participants	Living With Hope Program [Day 7] n=35 Participants	Living With Hope Program [Day 14] n=33 Participants	Living With Hope Program [3 Months] n=31 Participants	Living With Hope Program [6 Months] n=26 Participants	Living With Hope Program [12 Months] n=22 Participants
General Self-Efficacy Score (GSES)	31.1 units on a scale Standard Deviation 3.94	33.04 units on a scale Standard Deviation 4.03	32.44 units on a scale Standard Deviation 4.41	32.63 units on a scale Standard Deviation 3.64	33.2 units on a scale Standard Deviation 3.74	33.2 units on a scale Standard Deviation 4.44

SECONDARY outcome

Timeframe: Baseline, 1week, 2 weeks, 3, 6 and 12 months

The Non-Death Revised Grief Experience Inventory measures grief that is not associated with the death of a person. It is a 22-item scale measuring four domains (existential concerns, depression, tension and guilt, and physical distress) of the grief experience. Responses are scored on a 6-point scale, ranging from slight disagreement to strong agreement, with higher total score indicating more grief and loss. The Non-Death Revised Grief Experience Inventory has a minimum score of 22 and a maximum score of 132.

Outcome measures

Outcome measures
Measure	Living With Hope Program [Baseline] n=36 Participants	Living With Hope Program [Day 7] n=35 Participants	Living With Hope Program [Day 14] n=33 Participants	Living With Hope Program [3 Months] n=31 Participants	Living With Hope Program [6 Months] n=26 Participants	Living With Hope Program [12 Months] n=22 Participants
Non-Death Revised Grief Experience Inventory	72.82 units on a scale Standard Deviation 23.92	71.75 units on a scale Standard Deviation 24.13	70.22 units on a scale Standard Deviation 22.23	73.26 units on a scale Standard Deviation 23.6	64.63 units on a scale Standard Deviation 25.59	66.29 units on a scale Standard Deviation 24.43

SECONDARY outcome

Timeframe: Baseline, 1week, 2 weeks, 3, 6 and 12 months

The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).