Primary Malignant Neoplasm of Gastrointestinal Tract Clinical Trial
Official title:
Feasibility of a Creative Writing Intervention in an Advanced Cancer Population: A Single Arm, Consecutive Cohort Study
To assess the feasibility of a creative writing intervention in an advanced cancer population. Given it is a relatively simple intervention delivered by a non-clinician, the investigators are interested in better understanding its pattern of effect on patient psychological adjustment. The investigators aim to assess its feasibility in this study in order to inform a future larger study that will utilize a control arm.
Participants will be recruited within 3 months of presenting with a new GI or lung primary,
non-curable malignancy. After consent, the participants will meet with the staff writer, who
is already part of the creative arts program, to determine the methods, themes and modalities
of creative writing to pursue. These choices will be revisited each session, as patients move
from one theme to another, and some patients may consistently choose a given modality such as
letters, while others will choose variety.
Participants will meet with the staff writer one-on-one by scheduled appointment in the
outpatient or inpatient setting at a minimum of once per month throughout a 6 month time
period after enrollment. This appointment is preferred to be in person, but due to the rural
setting may be conducted by telephone if needed. There will not be a protocol regarding the
length of and number of visits during the 6 month study period, but these quantities will be
recorded to use for analysis of effectiveness of the intervention.
Writing modality choices will include private thoughts and feelings in a journal, poetry,
letters to oneself or loved ones and narrative writing about significant life events. All
interventions will focus on a written product for the participant to have and potentially
share with caregivers if they desire.
Every 3 months patients will be asked to complete the following series of questionnaires:
ECOG PS, PGAC3, HADS4, DT5, CSE6, CD-RISC-107, PTGI-SF8, FACIT-Sp-Ex9, ESAS11 and PA10.
Patients will be followed for 9 months after enrollment or until death (whichever is
soonest). If a patient decides to discontinue the creative writing intervention before 6
months, the reason will be recorded and they will continue in the study for 9 months or until
death completing the questionnaires.
Anyone completing the first intervention with the creative writer will be evaluable for the
feasibility outcome. If the investigators see 50% of patients completing 3 months of the
creative writing intervention then this would indicate the intervention should be examined in
a larger pilot study. In addition, the investigators will carefully record accrual rate with
associated reasons for declining and number of patients able to complete the full planned
intervention with the creative writing. In planning for a larger pilot study next and given
the survey burden is high in this study, the investigators will plan to use a subset analysis
in order to see which factors were significantly affected by the creative arts intervention
;