Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Insomnia Severity Index (Morin & Espie, 2003) |
A psychometrically sound 7-item self-report measure of perceived sleep impairment. Each item is rated using a five-point Likert scale ranging from 0 (not at all) to 4 (very much), for a total score ranging from 0 to 28. The ISI was recently validated in a large, heterogeneous sample of cancer patients (Savard, Savard, Simard, & Ivers, 2005). |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Modified Edmonton Symptom Assessment System-Revised (ESAS-R) (Philip, Smith, Craft, & Lickiss, (1998) |
A daily assessment of potential side-effects. The ESAS-R assesses symptoms including pain, tiredness, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, and wellbeing on a 0-10 scale. The 9-item measure created for this study includes the pain, drowsiness, depression, anxiety, and wellbeing items and adds fatigue, irritability, forgetfulness, and concentration in a format that otherwise resembles the ESAS-R. |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Sleep diary (Carney et al., 2012) |
A standardized daily outcome measure in insomnia research. Each morning respondents require 2-4 minutes to record a) the number of hours slept, b) time in bed, c) sleep onset latency (estimated time in minutes that it took to fall asleep after going to bed), and d) number of awakenings. All medications taken are also recorded. Diary data are used to calculate wake time after sleep onset (the amount of time in bed minus total sleep time and sleep onset latency) and sleep efficiency (the ratio of total sleep time to time in bed). |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Positive and Negative Affect Schedule (negative subscale)(Watson, Clark & Tellegen, 1988) |
Comprises of 10 negative adjectives describing emotional states. Using a 5-point scale, respondents rate the extent to which each adjective is consistent with his or her current emotional state. |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Pain Intensity Ratings (Jensen, Turner, Romano, & Fisher, 1999) |
Self-reported current, worse, least, and average pain are each assessed. Good validity, reliability, sensitivity to change, and appropriateness to cancer pain have been reported (Jensen et al., 1999). |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Functional Assessment of Cancer Therapy-Cognition scale: Perceived Cognitive Impairment subscale (Wagner et al., 2004) |
|
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-10) (Espie, Inglis, Harvey, & Tessier, 2000) |
a 10-item self-report measure of maladaptive beliefs about sleep (e.g., beliefs about the immediate and long term negative consequences of insomnia, beliefs about the need for control over insomnia). Although developed as an analogue scale, it was transformed into a Likert-type scale with responses ranging from 1 (strongly disagree) to 6 (strongly agree). Thus, possible scores ranged from 10 to 60, with higher scores indicating more maladaptive cognitions regarding sleep. The DBAS has moderate reliability and validity (Edinger, Wohlegemuth, Radtke, Marsh, & Quillian, 2001). |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Pre-Sleep Arousal Scale (PSAS) (Nicassio, Mendlowitz, Fussell, & Petras, 1985) |
An 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal. Evidence of the internal consistency, test-retest reliability, and convergent validity have been reported by the authors in their initial publication. |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Multi-Dimensional Fatigue Inventory (MFI) (Smets, Garssen, Bonke, & de Haes, 1995) |
It consists of 5 subscales, and the authors recommend using the general fatigue subscale for investigations of overall levels of fatigue. The general fatigue (GF) subscale has been found to have good internal consistency (ranging from 0.83-0.90), and GF subscale scores have been shown to positively and significantly correlate with other self-report measures of fatigue. Scores on the sub¬scale range from 4 to 20, with higher scores indicating greater fatigue. It is frequently used with cancer patients (Smets, Garssen, Cull, & de Haes, 1996). |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Depression Anxiety Stress Scale - (DASS) (Lovibond & Lovibond, 1995) |
A 42-item self-report measure that can be reliably grouped into three scales: anxiety, depression, and stress; however, only the depression subscale will be included for the present study. The depression subscale has demonstrated high internal consistency (Cronbach's alpha = 0.96) in a clinical sample (Brown, Chorpita, Korotitsch, & Barlow, 1997). |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Work and Social Adjustment Scale (WSAS) (Mundt, Marks, Shear, & Griest, 2002) |
A brief, 5-item scale assesses patient's perspectives of impaired functioning in important life domains. The authors report a high level of internal consistency (Cronbach's alpha = .7-.94), good test-retest reliability and sensitivity to change with treatment. Subsequent studies have confirmed its psychometric properties (Mataix-Cols et al., 2006). |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Impact of Event Scale (IES) (Horowitz, Wilner, & Alvarez, 1979) |
A 15 item measure of subjective stress in relation to a specific stressor (e.g., cancer). It has strong psychometric properties and is frequently used in cancer research (Cella & Tross, 1986; Cella, Mahon, & Donovan, 1990; Thewes, Meiser, & Hickie, 2001). The four-point frequency scale is as follows: 0='not at all', 1='rarely', 3='sometimes', 5='often', allowing the calculation of a total score (with a possible range of 0-75) and separate intrusion and avoidance subscales scores (with a possible range of 0-35 and 0-40, respectively). Research in oncology suggests a score of = 40 is indicative of a significant stress response (Cella, Mahon, & Donovan, 1990). |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Assessment of Survivor Concerns (ASC) (Gotay & Pagano, 2007) |
A 5 item questionnaire designed to measure cancer specific concerns not covered in general quality of life measures. Each item is rated using a four-point Likert scale ranging from 1 (not at all) to 4 (very much). The first three questions load on a cancer-specific worry subscale and the last two measure general health worry. Evidence of internal consistency, convergent and discriminant validity have been demonstrated in the original article. A recent intervention study provides some evidence of its sensitivity to change (Hershman et. al., 2013). |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)- Global Quality of Life Subscale (Aaronson, Ahmedzai, & Bergman, 1993; Osoba et al., 1997) |
Global Quality of Life Subscale (Aaronson, Ahmedzai, & Bergman, 1993; Osoba et al., 1997) was developed and validated with cancer patients. The global quality-of-life scale, comprised of two items rated on a Likert-type scale with responses ranging from 1 (very poor) to 7 (excellent) will be used. Scores are transformed to provide a rating ranging from 0 to 100. |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Multi-Dimensional Fatigue Inventory (Smets, Garssen, Bonke, & de Haes, 1995) |
|
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Global Adherence Scale |
With acceptable internal consistency (Cronbach's alpha = .81) and construct validity, a modified version of the five-item Medical Outcomes Study General Adherence Scale (MOS-A; Kravitz et al., 1993) assesses compliance with treatment. The MOS-A was modified by replacing physician with psychologist, and sample items are "I followed my psychologist's suggestions exactly" and "I found it easy to do the things my psychologist suggested I do." Participants respond on a scale of 1 (none of the time) to 6 (all of the time). Total scores range from 5 to 30, with higher scores reflecting greater adherence. Scores on the MOS-A have been found to correlate with adherence to other types of regimes in areas of exercise and diet (DiMatteo et al., 1993), and to negatively correlate with barriers to treatment in the area of insomnia (Vincent, Lewycky, & Finnegan, 2008). |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Client Feedback Questionnaire |
A four item questionnaire to assess how confident participants are that the online program helped their sleep problem, if they plan to ask for further help (e.g., in person counseling), what they liked best about the program and what they would change to make the program better. |
October 2016 - October 2019, up to 3 years |
|
| Secondary |
Client Global Improvement and Overall Change (CGI)(Guy, 1976) |
Assesses patients' perceived global improvement. The CGI asked patients to report the overall change in their sleep and in sleep-related effects as a result of participation in their treatment. Participants are asked to rate the change in their sleep and not in any other problem such as chronic pain, depression, or anxiety. Response choices rang from very much improved (1) to very much worse (7). Evidence of the construct validity of the CGI-self-report version comes from the demonstration that CGI scores are significantly and positively associated with treatment-related changes in sleep parameters (e.g., TST, SE) (Vincent, unpublished). |
October 2016 - October 2019, up to 3 years |
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