Feasibility of a Creative Writing Intervention in an Advanced Cancer Population: A Single Arm, Consecutive Cohort Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Feasibility of a Creative Writing Intervention in an Advanced Cancer Population: A Single Arm, Consecutive Cohort Study

Conditions
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Primary Malignant Neoplasm of Lung, Primary Malignant Neoplasm of Gastrointestinal Tract

Intervention / Treatment
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* Other: First Session
* Other: Second Session
* Behavioral: Third through Sixth Sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must plan to receive follow up care at Dartmouth-Hitchcock. Participant must have a lung or GI primary cancer diagnosed in the last 3 months. Participant must have non-curable cancer as judged by the primary oncologist. Participant must be comfortable conversing in English (reading and writing in English is not required). Participant must be cognitively intact as judged by their responsible clinician. Participant must have access to a working telephone and be willing and available to participate by this modality as needed. Participants may be on anti-depressants and/or anxiolytics as long as the dosing has remained stable over the preceding 2 weeks. Exclusion Criteria: Participant is expected to die in 6 months or less as judged by the responsible clinician. Participant must not have already worked with the staff writer at Dartmouth Hitchcock prior to enrollment in this study. Participant with an activated durable power of attorney for health care or cognitive impairment that interferes with ability to understand prognosis as determined by the primary oncologist. Participant must not have uncontrolled physical symptoms.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: One<br>Creative writing and questionnaires interventions: First Session, Second Session, Third through Sixth Sessions | Other: First Session<br>* Creative Practice and Positive Re-enforcement<br>Other: Second Session<br>* Disease Related<br>Behavioral: Third through Sixth Sessions<br>* Life Review and Legacy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a creative writing intervention in an advanced cancer population | 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. | 29 months |