Study period for the procedure of enrolment, intervention delivery and data collection
Timepoint (week) | Enrolment/screening | Baseline (T0) | Allocation | Study period (6 weekly online ACT) | Postintervention (T1) | |||||||||||
1 | 2 | 3 | 4 | 5 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13–14 | 15–20 | 21–24 | |
ENROLMENT | ||||||||||||||||
Eligibility screen | X | X | X | X | ||||||||||||
Informed consent | X | X | X | X | ||||||||||||
Baseline assessment | X | |||||||||||||||
Randomisation | X | |||||||||||||||
Interventions | ||||||||||||||||
ACT+health education (n=20 dyads) |
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Health education control (n=20 dyads) |
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Assessments | ||||||||||||||||
Sociodemographics and disease-related characteristics
Primary outcomes | X | |||||||||||||||
Fatigue interference (FSI) (P) | X | X | ||||||||||||||
Caregiver burden: (ZBI) (C) | X | |||||||||||||||
Secondary outcomes | X | |||||||||||||||
Health-related quality of life (FACT-L) (P) | X | X | ||||||||||||||
Meaning of life (MLQ) (C) | X | X | ||||||||||||||
Psychological flexibility (CompACT) (P, C) | X | X | ||||||||||||||
Mindful attention (MAAS) (P, C) | X | X | ||||||||||||||
Feasibility | X | |||||||||||||||
Acceptability | X | |||||||||||||||
Focus group interview | X | |||||||||||||||
Data analysis | X | |||||||||||||||
Report writing | X | |||||||||||||||
Research dissemination | X |
Lines signify ACT intervention in study, while crosses indicate measurements taken.
ACT, acceptance and commitment therapy; C, caregivers; CompACT, Comprehensive assessment of Acceptance and Commitment Therapy processes; FACT-L, Functional Assessment of Cancer Therapy – Lung, Version 4; FSI, Fatigue Symptom Inventory; MAAS, Mindful Attention Awareness Scale; MLQ, The Meaning of Life questionnaire; P, patients; ZBI, The Zarit Caregiver Burden Inventory.