Step 1: Data Collection (ORBIT Phase Ia: Define)
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- Examined literature on FOR interventions |
- Identified skills to address FOR (Hall et al., 2018) |
- Convened experts in (a) the SMART-3RP intervention, (b) cancer survivorship, and (c) clinician stakeholders at recruitment site |
- Mapped FOR skills onto SMART-3RP treatment manual |
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- Identified NCCN Survivorship Health Behavior Guidelines to target health behavior content to cancer survivors |
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- Defined eligibility for Step 3 (e.g., survivors 3-30 months post-treatment) |
Step 2: Integration (ORBIT Phase Ib: Refine)
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- Synthesized findings from Step 1 into initial adaptation of treatment manual |
- Refined content of treatment manual to target FOR |
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- Refined procedures for single arm trial (e.g., in-person delivery) |
- 23 survivors participated in the in-person intervention (4 cohorts of 3-8 survivors) |
- Tested proof of concept pilot (Hall et al., 2020) |
- Assessed acceptability after each session and patient-reported outcomes at baseline, post-intervention, +1 month, and +3 months |
- Preliminary acceptability: 87% of post-session ratings were “High” or “Very High” in enjoyability |
- Exit interviews assessed survivors’ feedback about multimodal nature of intervention |
- Preliminary feasibility: 96% retention baseline to 3-month follow-up; 77% session attendance, feasibility of skills practice (16% at baseline, 76%post-intervention) |
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- Reductions in FOR post-intervention (d = 0.87) and 3-month follow-up |
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- Identified areas for further refinement: |
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- Eligibility: Expand to include long-term survivors and restrict to elevated FOR. Chief reason for ineligibility was cap on time since treatment; Limited benefits for survivors with low FOR at baseline.
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- Content: For all skill modalities, provide guidance on when to apply techniques when engaging in healthcare. Strong preference for learning a variety of skills; Desired tips for applying skills before, during, and after healthcare visits and cancer testing.
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- Delivery: Offer remote, group sessions. Strong preference for group delivery. Chief reasons for eligible survivors not enrolling were distance and time constraints. Chief reasons for missed sessions were late effects of treatments and travel logistics for attending in-person.
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Step 4: Stratified Focus Groups and Individual Interviews (ORBIT Phase Ia: Define)
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- 28 survivors participated in focus groups to identify FOR-related coping skills and healthcare engagement (3 focus groups w/ elevated FOR, 3 focus groups w/ non-elevated FOR) |
- Identified maladaptive coping skills and maladaptive healthcare engagement skills from elevated FOR groups |
- Survivors with elevated FOR (n = 15) were interviewed individually to identify preferences for intervention delivery |
- Identified adaptive coping skills and adaptive healthcare engagement skills from non-elevated FOR groups |
- Identified adaptive coping skills and adaptive healthcare engagement skills from non-elevated FOR groups |
- Refined treatment model to integrate themes about tolerance of uncertainty, coping skills, and healthcare engagement |
- Refined treatment model to integrate themes about tolerance of uncertainty, coping skills, and healthcare engagement |
- Identified willingness and preferences for synchronous virtual delivery |
- Identified willingness and preferences for synchronous virtual delivery |
- Integrated tips for adaptive healthcare engagement into content |
Step 5: Finalized Treatment Manual (ORBIT Phase Ib: Refine)
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- Adapted content of existing treatment manual based on Step 4 |
- Optimized treatment manual and procedures for synchronous virtual delivery |
- Finalized treatment manual |
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- Planned pilot feasibility RCT (ORBIT Phase IIb: Pilot) |
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