Guided imagery for treatment (GIFT): protocol of a pilot trial of guided imagery versus treatment as usual to address radiotherapy-related distress in head and neck cancer

Table 1 GIFT protocol schedule of assessments and procedures

	Screening and enrollment	Prior to RT	During radiation therapy (RT)^a							Post-RT
	Baseline	CT simulation visit	Week 1	Week 2	Week 3	Week 4	Week 5	Week 6	Week 7	Week 12
Enrollment
Consent	X
Eligibility^b	X
Randomization^c	X
Intervention
CT simulation		X
In-person or virtual GI session		X	X
Assessment
Demographics	X
Patient self-administered GI use^d			X	X	X	X	X	X	X
Anxiety HADS-A	X		X		X				X	X
Depression HADS-D	X		X		X				X	X
Symptoms MSAS-SF	X				X				X	X
Health-related QOL FACT-HN	X				X				X	X
Intervention use TLFB-I^d		X	X	X	X	X	X	X	X
Anxiolytic use TLFB-A		X	X	X	X	X	X	X	X
Qualitative interview
Research assistant contact for F/U^e										X
Qualitative interview^f										X

^aPatients may complete the assessments for weeks 1, 3, 7, and 12, listed above any time during the specified week (7 days) of treatment, with day 1 being defined as the first day of radiation treatment. TLFB measures may be completed at any time
^bdetermined by chart review and confirmation of eligibility between research study personnel and treating physician
^cupon completion of baseline measures
^dguided imagery (intervention) participants only
^efollowing completion of 12-week study measures, in person or on the phone; treatment as usual participants will be provided with an MP3 player containing the guided imagery audio files either in person or by mail. Intervention participants will be offered the opportunity to participate in a 30-min qualitative interview assessing the acceptability and feasibility of the intervention
^fthe qualitative interview may be conducted via phone or in person following completion of the week 12 study assessments

ISSN: 2055-5784