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NCT02575898 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02575898
Other study ID # D15113
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2016
Est. completion date September 4, 2018

Study information
Verified date November 2018
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date September 4, 2018
Est. primary completion date July 12, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Participant must plan to receive follow up care at Dartmouth-Hitchcock.

2. Participant must have a lung or GI primary cancer diagnosed in the last 3 months.

3. Participant must have non-curable cancer as judged by the primary oncologist.

4. Participant must be comfortable conversing in English (reading and writing in English is not required).

5. Participant must be cognitively intact as judged by their responsible clinician.

6. Participant must have access to a working telephone and be willing and available to participate by this modality as needed.

7. Participants may be on anti-depressants and/or anxiolytics as long as the dosing has remained stable over the preceding 2 weeks.

Exclusion Criteria:

1. Participant is expected to die in 6 months or less as judged by the responsible clinician.

2. Participant must not have already worked with the staff writer at Dartmouth Hitchcock prior to enrollment in this study.

3. 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.

4. Participant must not have uncontrolled physical symptoms.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• First Session
Creative Practice and Positive Re-enforcement
• Second Session
Disease Related
Behavioral:
• Third through Sixth Sessions
Life Review and Legacy

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (1)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (16)

Ando M, Tsuda A, Morita T. Life review interviews on the spiritual well-being of terminally ill cancer patients. Support Care Cancer. 2007 Feb;15(2):225-31. Epub 2006 Sep 12. — View Citation

Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198. — View Citation

Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, Dionne-Odom JN, Frost J, Dragnev KH, Hegel MT, Azuero A, Ahles TA. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1438-45. doi: 10.1200/JCO.2014.58.6362. Epub 2015 Mar 23. — View Citation

Bohlmeijer E, Smit F, Cuijpers P. Effects of reminiscence and life review on late-life depression: a meta-analysis. Int J Geriatr Psychiatry. 2003 Dec;18(12):1088-94. — View Citation

Chochinov HM, Hack T, Hassard T, Kristjanson LJ, McClement S, Harlos M. Dignity therapy: a novel psychotherapeutic intervention for patients near the end of life. J Clin Oncol. 2005 Aug 20;23(24):5520-5. — View Citation

Chochinov HM, Kristjanson LJ, Breitbart W, McClement S, Hack TF, Hassard T, Harlos M. Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. Lancet Oncol. 2011 Aug;12(8):753-62. doi: 10.1016/S1470-2045(11)70153-X. Epub 2011 Jul 6. — View Citation

Crogan NL, Evans BC, Bendel R. Storytelling intervention for patients with cancer: part 2--pilot testing. Oncol Nurs Forum. 2008 Mar;35(2):265-72. doi: 10.1188/08.ONF.265-272. — View Citation

Dionne-Odom JN, Azuero A, Lyons KD, Hull JG, Tosteson T, Li Z, Li Z, Frost J, Dragnev KH, Akyar I, Hegel MT, Bakitas MA. Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1446-52. doi: 10.1200/JCO.2014.58.7824. Epub 2015 Mar 23. — View Citation

Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27. — View Citation

Julião M, Oliveira F, Nunes B, Vaz Carneiro A, Barbosa A. Efficacy of dignity therapy on depression and anxiety in Portuguese terminally ill patients: a phase II randomized controlled trial. J Palliat Med. 2014 Jun;17(6):688-95. doi: 10.1089/jpm.2013.0567. Epub 2014 Apr 15. — View Citation

Korte J, Bohlmeijer ET, Cappeliez P, Smit F, Westerhof GJ. Life review therapy for older adults with moderate depressive symptomatology: a pragmatic randomized controlled trial. Psychol Med. 2012 Jun;42(6):1163-73. doi: 10.1017/S0033291711002042. — View Citation

Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013 Jun 10;173(11):960-9. doi: 10.1001/jamainternmed.2013.836. Review. — View Citation

Steinhauser KE, Alexander SC, Byock IR, George LK, Olsen MK, Tulsky JA. Do preparation and life completion discussions improve functioning and quality of life in seriously ill patients? Pilot randomized control trial. J Palliat Med. 2008 Nov;11(9):1234-40. doi: 10.1089/jpm.2008.0078. — View Citation

Tegner I, Fox J, Philipp R, et al. Evaluating the use of poetry to improve well-being and emotional resilience in cancer patients. J Poetry Ther 2009; 22: 121-131.

Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 2011 Jun 10;29(17):2319-26. doi: 10.1200/JCO.2010.32.4459. Epub 2011 May 9. — View Citation

Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary 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