Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Intervention Acceptability: Session Feedback Questionnaire |
Participant value of the session will be assessed through the Session Feedback. Possible scores range 4-20, with higher scores indicating higher value and acceptability of the session. |
Once weekly during intervention period from Pre to Post (6 weeks after baseline, e.g., at the end of each weekly session during the intervention period) |
|
Other |
Intervention Acceptability: Client Satisfaction Questionnaire-8 |
Participant satisfaction will be measured using the Client Satisfaction Questionnaire-8 (adapted to the current intervention). Possible scores range 8-32, with higher scores indicating more satisfaction. |
Assessed and reported two times: 6 weeks after baseline (Post), 3-month follow-up (FU) |
|
Primary |
Cancer-related trauma symptoms |
A primary outcome will be change in cancer-related trauma symptoms, assessed by the 22-item Impact of Events Scale-Revised. Possible scores range 0-88 with higher scores indicating greater distress/bother. |
Assessed seven times: prior to the intervention (Pre), before each intervention session, 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|
Primary |
Fear of cancer progression |
A primary outcome will be change in fear of cancer progression, assessed by the 12-item Fear of Progression Questionnaire - Short Form and by the four general scale items from the Concerns about Recurrence Scale, with wording adapted to focus on cancer progression rather than recurrence. Range: 12-60, higher scores are associated with higher fear of cancer progression. |
Assessed: prior to the intervention (Pre), before each intervention session, 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|
Primary |
Intervention acceptability |
Assessed with the Acceptability of Intervention Scale. Possible scores range from 4-20, with higher scores indicating greater intervention acceptability. |
Assessed in order to compare values at 2 timepoints: 6 weeks after baseline (Post) and separately at 1.5-month follow-up (FU) |
|
Primary |
Intervention Feasibility |
For participants who begin the intervention, at least 70% complete all intervention sessions |
Assessed at each intervention session 1-5, 1 to 5 weeks after baseline. |
|
Secondary |
Patient Health Questionnaire (PHQ-8) |
Patient-reported depression symptom questionnaire. Range is 0 to 24. Higher scores indicate more depression symptoms |
Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post),, at 1.5 and 3-month follow-up (FU) |
|
Secondary |
Generalized Anxiety Disorder-7 Questionnaire |
Patient-reported anxiety symptom questionnaire. Possible scores range from 0-21, with higher scores indicating more anxiety symptoms |
Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|
Secondary |
The Death Attitude Profile-Revised, Fear of Death and Death Avoidance Scales |
Patient-reported fear of death and dying questionnaire. Possible scores range from 12-84, with higher scores indicating greater fear of death and dying |
Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|
Secondary |
Hopelessness Assessment in Illness Questionnaire 8-item |
Patient-reported hopelessness specifically intended for use with adults with incurable cancer. Possible scores range 0-16, with higher scores indicating greater hopelessness. |
Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|
Secondary |
The Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form v1.0 |
Patient-reported levels of fatigue. Possible scores range 6-30, with higher scores indicating greater fatigue. |
Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|
Secondary |
The Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference-Short Form v1.0 |
Patient-reported dimension of pain interference (e.g., the extent to which pain interferes with daily life and life roles). Possible scores range 6-30, with higher scores indicating greater pain. |
Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|
Secondary |
Emotional Approach Coping Scale (COPE): Avoidance coping (process measure) |
Patient-reported coping through avoidance using three avoidance coping scales (mental disengagement, denial, physical disengagement) with cancer as the anchor. Possible scores range 8-28, with higher scores indicating greater denial, mental and behavioral disengagement. |
Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|
Secondary |
Five Factor Mindfulness Questionnaire, Nonjudge and nonreact scales (process measure) |
Patient-reported coping through acceptance. Possible scores range 15-75, with higher scores reflecting greater nonreactivity and nonjudging of inner experience. |
Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|
Secondary |
Valuing Questionnaire |
Valued engagement in daily life. Possible scores range 0-30 for each of the two subscales with higher scores indicating greater engagement and sense of purpose in life. |
Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|
Secondary |
Self-compassion Scale-Short Form |
Self-compassion questionnaire. Possible scores range 12-60 with higher scores indicating higher self-compassion. |
Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU) |
|