Leveraging a Novel Mixed-Methods Approach to Deepen Insights From Exit Interviews and Trial Data in a Randomized Trial of Cancer Cachexia
Author(s)
Jarjieh Fang, MPH1, Joshua A. Roth, MHA, PhD2, John Groarke, MBBcH, MPH3, Magdalena A. Harrington, PhD3;
1Pfizer, New York, NY, USA, 2Pfizer, Seattle, WA, USA, 3Pfizer, Cambridge, MA, USA
1Pfizer, New York, NY, USA, 2Pfizer, Seattle, WA, USA, 3Pfizer, Cambridge, MA, USA
OBJECTIVES: In-trial interviews provide insights into patient experiences and identify meaningful treatment benefits. Many clinical trials conduct in-trial interviews but use results to only validate Patient Reported Outcome (PRO) measures, rather than to interpret PRO data, a sub-optimal utilization of the patient voice. This research explores novel approaches to advance the interpretation of trial data.
METHODS: Semi-structured telephone interviews were conducted with adult patients with cancer cachexia following the last study visit in a randomized, double-blind, phase 2 trial (NCT05546476). Verbatim transcripts were analyzed using thematic analysis methods to deepen the interpretation of clinical trial results by analyzing phase 2 PRO results alongside qualitative results in aggregate and by matching exit interviews data with PRO data of the same participants.
RESULTS: Twelve patients (58.3% female; mean pre-trial weight loss 39.4 lbs.) completed interviews. Qualitative and PRO results suggested complementary results in patient experiences with pre-trial appetite loss and appetite improvement over trial period. The interviews described how appetite related to the patients’ treatment experiences and to other symptoms and impacts of cancer cachexia, such as nausea and pain. While patient interviews described improvements in ability to accomplish activities of daily living, PROMIS Physical Function Short Form 8c findings diverged. Interview results related to patients’ physical fatigue experience converged with the PROMIS Fatigue Short Form 7a results.
CONCLUSIONS: Our mixed-methods approach enriched insights from exit interviews and randomized trial data in cancer cachexia, providing a more comprehensive understanding of patient experiences and treatment benefits. Findings also highlight the important role of qualitative data in interpreting trial results. This approach underscores the value of integrating qualitative interviews with trial data to enhance the interpretation and application of clinical trial results and should be considered in future trials.
METHODS: Semi-structured telephone interviews were conducted with adult patients with cancer cachexia following the last study visit in a randomized, double-blind, phase 2 trial (NCT05546476). Verbatim transcripts were analyzed using thematic analysis methods to deepen the interpretation of clinical trial results by analyzing phase 2 PRO results alongside qualitative results in aggregate and by matching exit interviews data with PRO data of the same participants.
RESULTS: Twelve patients (58.3% female; mean pre-trial weight loss 39.4 lbs.) completed interviews. Qualitative and PRO results suggested complementary results in patient experiences with pre-trial appetite loss and appetite improvement over trial period. The interviews described how appetite related to the patients’ treatment experiences and to other symptoms and impacts of cancer cachexia, such as nausea and pain. While patient interviews described improvements in ability to accomplish activities of daily living, PROMIS Physical Function Short Form 8c findings diverged. Interview results related to patients’ physical fatigue experience converged with the PROMIS Fatigue Short Form 7a results.
CONCLUSIONS: Our mixed-methods approach enriched insights from exit interviews and randomized trial data in cancer cachexia, providing a more comprehensive understanding of patient experiences and treatment benefits. Findings also highlight the important role of qualitative data in interpreting trial results. This approach underscores the value of integrating qualitative interviews with trial data to enhance the interpretation and application of clinical trial results and should be considered in future trials.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
MSR78
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Pediatrics