Table 3
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) |
| |||||||||||||||
| Health education control (n=20 dyads) |
| |||||||||||||||
| 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.